Surg Endosc DOI 10.1007/s00464-015-4405-5
and Other Interventional Techniques
The role of single-balloon colonoscopy for patients with previous incomplete standard colonoscopy: Is it worth doing it? Michael Christian Sulz1 • Remus Frei1 • Gian-Marco Semadeni1 • Mikael Sawatzki1 Jan Borovicka1 • Christa Meyenberger1
•
Received: 7 February 2015 / Accepted: 2 July 2015 Ó Springer Science+Business Media New York 2015
Abstract Background The rate of cecal intubation is a well-recognized quality measure of successful colonoscopy. Infrequently, the standard colonoscopy techniques fail to achieve complete examination. The role of single-balloon overtube-assisted colonoscopy (SBC) in these situations has only been sparsely studied. This prospective singlecenter study aimed to investigate the technical success (rate of cecal intubation) and the diagnostic gain of SBC. Methods The study recruited consecutive patients with previous incomplete standard colonoscopy who were admitted for SBC at our tertiary center in Eastern Switzerland between February 2008 and October 2014. The primary outcome was defined as successful cecal intubation. Data on patient characteristics, indication, technical details of procedure, and outcome were collected prospectively. The Olympus enteroscope SIF-Q180 was used. Results The study included 100 consecutive patients (median age 70 years; range 38–87 years; 54 % female) who were examined using a single-balloon overtube-assisted technique. The cecal intubation rate was 98 % (98/ 100). The median time of total procedure was 54 min (range 15–119 min); the median time to reach the cecal pole was 27.5 min (range 4–92 min). Passage of the sigmoid colon was not possible in two cases with a fixed, angulated sigmoid colon. The diagnostic gain was 21 % regarding adenomatous polyps in the right colon. The
& Michael Christian Sulz [email protected] 1
Division of Gastroenterology and Hepatology, Kantonsspital St. Gallen, Rorschacherstrasse 95, 9007 St. Gallen, Switzerland
complication rate was 2 % (2/100, minor) without need for surgery. Conclusions This prospective patient cohort study shows that single-balloon colonoscopy is a safe and effective procedure to achieve a complete endoscopic examination in patients with a previous failed standard colonoscopy. A significant diagnostic and therapeutic gain in the right colon justifies additional procedure time. Keywords Single-balloon Colonoscopy Incomplete Cecal intubation The colon can be visualized using a variety of modern radiological cross-sectional imaging techniques (e.g., colonography by computed tomography or magnetic resonance imaging) and noninvasive endoscopy devices (e.g., wireless video capsule colonoscopy). However, standard flexible endoscopy remains the mainstay of colon disease diagnosis because it is the only technique that allows tissue sampling and performing interventions. Moreover, colonoscopy is the most sensitive available examination for colon pathology detection [1]. International guidelines specify a 90 % rate of successfully reaching the cecum as one major quality index for colonoscopy [2]. Despite improvements in endoscopic equipment and sedation methods, endoscopists still fail to achieve cecal intubation in 5–10 % of cases [3, 4]. This is due to a number of demographic and clinical factors, including older age, female gender, low body mass index (BMI), diverticular disease, insufficient colon cleansing, previous abdominal or pelvic surgery, and anatomical reasons (e.g., redundant colon, dolichocolon, and fixed angulation) [5–7]. In the event of incomplete standard colonoscopy (SC), various endoscopic adaptations can be used to improve the
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chances of success—for example, the pediatric colonoscope, variable stiffness colonoscope, colonoscopy with magnetic guidance, and thinner and more flexible gastroscopes. Additionally, accessory overtubes can allow better colonoscope straightening and thus reduce looping. Among patients with previously failed SC, double-balloon-assisted endoscopy has achieved successful cecal intubation in 88–100 % of cases [8–12]. Over recent years, single-balloon overtube-assisted colonoscopy (SBC) has gained attention. However, to date, only a few fairly small case series are available [13–15], and it remains unclear whether it is worthwhile to perform SBC after incomplete SC. One recently published study concluded that achieving a complete colonic evaluation in patients with previous incomplete colonoscopy was worth the effort [16]. Here we present the so far largest prospective singlecenter study of SBC in cases of previous incomplete SC. This study aimed to add to the published experience with this promising technique, to investigate its technical success rate, and to determine the number of relevant findings in the right hemicolon that were recognized due to the additional effort of SBC compared to the previous incomplete SC.
Materials and methods The present series prospectively included consecutive patients who had an incomplete SC and were admitted for SBC between February 2008 and November 2014. Exclusion criteria included pregnancy, age of \18 years, or failure to provide informed consent. The study was performed in the state hospital of St. Gallen, Switzerland, a tertiary referral center with an average annual case volume of 2500 SCs and serving a population of 500,000 inhabitants. The average annual case volume included 70 singleballoon-assisted endoscopies in the upper and lower gastrointestinal tract. This study was approved by the local ethics committee (EKSG/13/164). Previous incomplete standard colonoscopy (SC) All patients previously underwent SC performed either by gastroenterologists with [10 years of experience performing colonoscopies (each [4000 colonoscopies) in local private practices and district hospitals, or by the endoscopy staff at our center. Incomplete SC was defined as failure to intubate the cecum (i.e., without identification of the ileocecal valve and triradiate fold) or cancellation of colonoscopy due to intolerable pain during the procedure despite sedation with propofol and midazolam or pethidine. Causes for incomplete colonoscopy were either a redundant colon where the cecum could not be reached due to
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excessive looping or a tortuous colon or a fixed angulation of the rectosigmoid that could not be passed. When a colonoscopy was performed by a trainee at our center, an experienced fully trained gastroenterologist tried to complete the examination before it was stopped without completion and regarded as failed. It was left at the discretion of each endoscopist who performed the SC whether to switch to another standard endoscope (e.g., pediatric colonoscope or gastroscope), to use the stiffness function (if available), or to use fluoroscopy or scope guide, and when to stop the SC if further attempts were estimated to be potentially harmful. There was no predetermined time limit to achieve cecal intubation. Thereafter, we proceeded directly to SBC without another attempt of SC in our unit. The double-balloon endoscope (DBE) system was not anymore in use at our institution. Single-balloon colonoscopy (SBC) Bowel preparation was achieved using polyethylene glycol (Macrogol; Norgine, Amsterdam, the Netherlands). Three liters was administered one night prior to the procedure, followed by another liter in the morning on the day of the procedure. The procedures were usually performed under conscious sedation with non-anesthesiologist-administered propofol (AstraZeneca AG, Zug, Switzerland). Patients with multi-morbidity and/or American Society of Anesthesiologists (ASA) classification III/IV were evaluated by anesthetists who decided whether to perform monitored anesthesia care or general anesthesia. Healthy patients without suspicion of active bleeding were usually treated as outpatients. SBC was performed with a single-balloon enteroscopy system (Olympus SIF-Q180 with overtube; Olympus, Tokyo, Japan). This extra-long, thin endoscope (200 cm length; 9.2-mm outer diameter) has a 140-degree field of view. The moveable rigid overtube carries an inflatable and deflatable balloon on its top, allowing stabilization and straightening of the colon. SBC was performed using standard practices with a nurse’s assistance. The overtube was backloaded onto the enteroscope, and then, the enteroscope was advanced until the overtube reached the anus. The overtube with the balloon deflated was then generously lubricated and advanced over the endoscope until either significant resistance was met or the overtube reached the tip of the endoscope. Next, the air was suctioned from the colon, and the overtube balloon was inflated. If loops were shown under fluoroscopic control (Fig. 1), the endoscopist grasped and withdrew both the endoscope and balloon overtube, applying gentle torque to reduce the loop (Fig. 2). Subsequently, the endoscope was again maximally advanced, and the process was repeated until reaching the cecum and/or ileum. The examinations
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square test were used to assess significance when comparing categorical variables (e.g., gender). A p value of B0.05 was considered significant. The STATA 12.0 program (StataCorp LP, College Station, Texas, USA) was used for statistical analysis.
Results
Fig. 1 Fluoroscopy during colonoscopy shows fixed loops in the sigmoid colon. The large arrow shows the inflated balloon of the overtube (small arrow pointing to the tip of the overtube)
Fig. 2 Single-balloon overtube-assisted colonoscopy with fluoroscopic guidance. Inlay shows straightened loops after passage of the sigmoid colon
were performed by six endoscopists, including two trainees and four who were experienced in single-balloonassisted endoscopy ([50 procedures). Data were prospectively collected on sex, age, BMI, ASA classification, indication, details of the previous incomplete SC (if applicable), technical details of SBC procedure, and outcome. Statistical analysis Data were analyzed with the use of descriptive statistics. As appropriate, Fisher’s exact test and Pearson’s Chi-
Between February 2008 and November 2014, 100 consecutive patients with a previous incomplete SC underwent colonoscopy with the single-balloon overtube-assisted technique with the aim of complete examination of the colon. The median age was 70 years (age range 38–87 years), 54 % of the patients were female, and the median BMI was 25.2 kg/m2 (BMI range 17.1–49.0 kg/ m2). Table 1 presents details regarding the patient characteristics and technical information about the previous incomplete SC. Out of 100 patients, 45 (60 % female) had a history of previous abdominal and/or pelvic surgery. In 22/100 cases, the endoscopist switched during the initial incomplete SC to a different standard endoscope (54.5 % pediatric colonoscope, 36.5 % gastroscope 36.5 %) without being successful. The main indication for colonoscopy was abdominal pain (18 %) (Table 2). Of the 100 patients, 11 % underwent SBC for colorectal cancer/polyp screening and 6 % for polyp surveillance (Table 2). The technical success rate of SBC was 98 %, with success defined as cecal intubation and recognition of the ileocecal valve and the appendiceal orifice (Table 3). Passage of the sigmoid colon with the SIF-Q180 endoscope was not technically possible in two patients, both of whom had a fixed, angulated sigmoid colon. One of these patients was a female with severe peritoneal carcinomatosis, and the other was a male with extensive diverticulosis. The median duration of the total procedure was 54 min (range 15–119 min), and the median time to reach the cecal pole was 27.5 min (range 4–92 min) (Table 2). In 94/100 patients, SBC was performed under conscious sedation (non-anesthesiologist-administered propofol, alone or in combination with midazolam or pethidine). Only two cases required general anesthesia, and four cases required monitored anesthesia care (Table 2). Two minor complications (2 %) occurred (Table 3). One patient exhibited a single mucosal defect after the polypectomy. The defect was successfully closed with hemoclips, and the patient received prophylactic antibiotics and remained asymptomatic. Another patient suffered from severe abdominal pain and hematochezia after a diagnostic SBC without intervention. Computed tomography results excluded perforation. This outpatient was then admitted for medical observation and was discharged home pain-free after 4 days.
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Surg Endosc Table 1 Patient characteristics and technical details of previous incomplete standard colonoscopy
Table 2 Technical details of single-balloon colonoscopy
Demographic data
Polyp surveillance
Indication, na 6
Number of patients, n
100
Screening for polyps/early colorectal cancer
Age in years, median (range)
70 (38–87)
Positive family history of colorectal cancer
9 4
Sex, female:male
54:46
Anemia
BMI in kg/m2, median (range)
25.2 (17.1–49)
Abdominal pain
ASA [n (%)]
Bleeding
11
18 6
I
46 (46)
Diarrhea
16
II
32 (32)
Other
31
III
22 (22)
Time to cecal pole in minutes, median (range)
IV Number of patients with previous abdominal and/ or pelvic surgery [n (%)], female:male
0 45 (45), 27:18
Ratio in-house/out-of-house incomplete colonoscopies
43:57
Reason for incomplete colonoscopy [n (%)] Loop
55 (55)
Colon elongatum
17 (17)
Descending colon
100
Propofol dosage in mg, median (range) Propofol combined with Midazolam, n Propofol combined with Pethidine, n Propofol dosage in mg, median (range)
28 (28)
Fixed sigma Part of colon reached [n (% females)] Sigmoid colon
54 (15–119)
Use of sedation, n Propofol alone, n
Previous incomplete standard colonoscopy
6 (16.6)
4
General anesthesia, n
2
Total n is [100 due to combination
Table 3 Outcome of single-balloon colonoscopy Technical success (i.e., cecal intubation) [n (%)]
Endoscopes used, n Colonoscope
78
Complications [n (%)]
Pediatric colonoscope
20
Findings (n/100 patients)
2
Patients with any finding Diverticulosis
22 12 (54.5)
Colitis Colorectal cancer
Use of additional aids, overall, n
21
Polyps, (female:male)
5 (24)
Repeat colonoscopies before SBC, overall, n Once
20 18
Twice
2
Total number of polyps, n (right colon/transverse colon/left colon)
The overall rate of findings was 86 % (Table 3). Of the 100 patients, 54 showed a marked diverticulosis and 47 showed at least one polyp within the colon. The overall adenoma detection rate was 34/100, of which 21 patients had adenomas in the right colon, and 9 had adenomas in the transverse colon (Table 3). Nearly all polyps could be removed. One adenocarcinoma was detected in the sigmoid colon. Among the 13 patients who underwent SBC for polyp/colorectal cancer screening, adenomas were detected
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1 47 (22:25) 113 (55/18/38)
Adenomatous polyps Adenoma detection rate, overall Right colon Transverse colon
ASA American Society of Anesthesiologists, BMI body mass index
86/100 54 4
8 (36.5) 2 (9.0)
Scopeguide [n (%)]
2 (2)
2
Switch to gastroscope [n (%)]
16 (76)
98 (98)
Angiodysplasia
Switch to both [n (%)] Fluoroscopy [n (%)]
325 (102–751)
2 (100) 31 (38.7)
Switch to pediatric colonoscope [n (%)]
34 2
61 (63.9)
Right flexure
Switch to other standard endoscope, n
58 369 (100–806)
Monitored anesthesia care, n a
Left flexure
Gastroscope
27.5 (4–92)
Total procedure time in minutes, median (range)
Left colon Adenoma detection rate in patients admitted for polyp/colorectal cancer screening [n (%)]
34/100 21/100 9/100 16/100 6/13 (46.2)
Histology of polyps in the right colon (%) Tubular adenoma
59.3
Tubulovillous adenoma
11.1
Sessile serrated adenoma Hyperplastic polyp
7.4 14.8
Therapy, overall [n (%)]
46 (46)
Polypectomy [n (%)]
45 (97.8)
Argon plasma coagulation [n (%)]
1 (2.2)
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in 6 (46.2 %). Other findings included a few cases of colitis and angiodysplasia (Table 3).
Discussion Here we describe the so far largest prospective singlecenter study of SBC in 100 patients with prior incomplete SC. We reported a high technical success rate of 98 % in this group of selected patients and a 21 % diagnostic gain regarding adenomatous polyps in the right colon. To date, the literature includes only few and relatively small case series investigating this subject [13–15]. Teshima et al. [14] performed 23 SBC in 22 patients with previous incomplete SC and showed a 96 % cecal intubation success rate. May et al. [15] reported a 100 % success rate for SBC in 14 patients who previously underwent a failed SC. As in our present series, these prior case series reported no procedure-related complications. The strength of our study is that the findings of previous studies, namely the feasibility, the high technical success rate of SBC, and the relevant diagnostic gain of completed colonoscopy in patients with previous incomplete colonoscopy could be confirmed with a high sample size. The European Society of Gastrointestinal Endoscopy (ESGE) [17] states that endoscopists should achieve a cecal intubation rate of above 90 %. However, in clinical practice, incomplete colonoscopy is reported in up to 13 % of patients [18]. These failures are related to several factors, including prior abdominal surgery (resulting in adhesions), severe diverticular disease, inadequate bowel cleansing, patient discomfort, low BMI (\18.5 kg/m2), and female gender [18]. Important causes for incomplete colonoscopy are also either a redundant colon where the cecum could not be reached due to excessive looping or a tortuous colon or a fixed angulation of the rectosigmoid that could not be passed. In patients who undergo an incomplete colonoscopy, complete colonic evaluation can be achieved using a variety of techniques. Depending on the local facility, expertise, and habits, the options may include computed tomography or magnetic resonance colonography, as well as video capsule colonoscopy, repeat endoscopy with or without water immersion or cap assistance, or balloon-assisted colonoscopy. The special features of SBC allow the endoscopist to overcome the aforementioned difficult anatomical conditions in patients with previously incomplete SC. The single-balloon enteroscope is very thin and extra-long (200 cm length; 9.2 mm outer diameter) with a high degree of flexibility and mobility suitable in a fixed angulated rectosigmoid. The moveable rigid overtube with the inflatable and deflatable balloon on its top provides the required stabilization and straightening of redundant or tortuous colon. While the inflated balloon stabilizes the
endoscope within the colon, the SB enteroscope is advanced up to 50 cm; thereafter, the overtube with deflated balloon is gently pushed up. This alternating process is repeated until the cecum and/or ileum is reached. As described above, a variety of options exist to achieve complete colonic evaluation. However, it remains unclear whether complete colonoscopy is really needed and what is gained from the extra effort and cost of performing an additional technical procedure. One recent study concluded that it was worth the effort required to achieve a complete colonic evaluation in patients with incomplete colonoscopy [16]. Repeat colonoscopy in 71 patients with previous incomplete colonoscopies revealed 32 lesions (24 tubular adenomas, 4 tubulovillous adenomas, and 4 sessile serrated polyps) in 17 patients (24 %) [16]. In our present study, 47/100 patients had at least one polyp (34/100 patients with adenomatous polyps), among whom 21 patients had adenomatous polyps in the right colon. This high technical success rate and the diagnostic gain associated with complete colonic evaluation certainly appear to legitimize the practice of SBC. However, it may be more cost-effective to repeat SC in these patients rather than to refer them to a tertiary center for SBC, which is less widely available and more expensive. A recently published Canadian study with 90 patients demonstrated that most patients with a previous incomplete colonoscopy can undergo a successful repeat colonoscopy at a tertiary care center, showing a cecal intubation rate of 97 %, mainly utilizing standard preparation, sedation, and patient positioning [19]. In that study, gastroscopes were only used in 6 % of cases and pediatric colonoscopes in 7 %. However, it is difficult to compare their results with those of the present study. The authors of the Canadian study stated that only 33 % of their patients were previously seen by gastroenterologists. In contrast, all of our present patients referred for SBC had previously undergone SC performed by experienced gastroenterologists in private practices, district hospitals, or in our own unit highlighting the selection of difficult colonoscopies in our study. Gawron et al. [20] also demonstrated the success of repeating SC, achieving cecal intubation in 96 of 100 repeated examinations, 83 of which were completed with a standard endoscope (adult or pediatric colonoscope, or gastroscope). In particular, patients with a tortuous colon more frequently had a complete repeat procedure with a standard endoscope that was not used in the prior incomplete procedure [20]. However, data in literature are contradictory. Keswani et al. [13] randomized 30 patients with incomplete SC to either repeat SC or SBC. SBC was successful in 92.9 % and repeat SC only in 50 %. Those failed repeat SC were then switched to SBC, with a success rate of 100 % [13], emphasizing the impact of SBC in some situations.
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Considering the currently available data as well as the additional technical supplies needed for balloon overtubeassisted endoscopy, it may be easier and less expensive to initially repeat the colonoscopy using standard endoscopes, as suggested by Gawron et al. [20]. The use of a gastroscope is recommended in patients with a tortuous colon that could not be reached using a pediatric colonoscope, as is the use of an adult or pediatric colonoscope in patients with a redundant colon [20]. In any situation, it is advised to use water immersion with no or only minimal air insufflation, as this practice is associated with significantly lower use of an external straightener and less frequent patient position changes compared to air insufflation [21]. Our prospective study showed that SBC has a great potential, with an excellent colonoscopy completion rate and very few complications in the hand of skilled endoscopists. However, it might be best to reserve this procedure for really difficult cases after a second failure of SC in a redundant or tortuous colon. Prospective multicenter randomized trials are needed to evaluate the value of balloon-assisted colonoscopy in the event of incomplete colonoscopy in clinical practice. Double-balloon colonoscopy is another balloon overtubeassisted technique, using an overtube with two balloons. Only scarce data are available to compare single-balloon and double-balloon colonoscopy techniques. One randomized controlled trial with only 21 patients (11 single balloon, 10 double balloon) revealed no significant difference between these two balloon techniques; however, the time to cecal intubation was lower in the group with double-balloon colonoscopy [22]. Double-balloon colonoscopy certainly is also a good option in patients with incomplete SC. However, we decided in 2007 to abandon double-balloon-assisted endoscopy due to feasibility reasons. Since then, we performed all balloon-assisted endoscopies in single-balloon technique. In our opinion, double-balloon-assisted endoscopy is technically more elaborate for the staff; especially for colonoscopy, we think that practicing gastroenterologists may find SBC easier to learn and more intuitive than doubleballoon colonoscopy having two balloon cycles. The Olympus SB enteroscope is stiffer than the Fujinon doubleballoon endoscope (Fujinon Inc., Saitama, Japan) which might be especially suitable when passing redundant colon loops. However, local habits, expertise, and availability determine which type of balloon-assisted endoscope system is utilized at a certain facility. Our study has several limitations. First, this study represents the experience of a Swiss tertiary endoscopy center that receives external referrals for SBC only from experienced gastroenterologists in private practices and district hospitals. Therefore, the patients with a previous incomplete SC are a highly selected group. It is difficult to compare our patients with patients from countries where endoscopy is also
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performed by general internists or surgeons. Second, this was a single-center study with a selection bias. Therefore, the results are not easily generalizable to other practice settings and individual endoscopists. However, the sample size was large compared to other case series in which this topic has been investigated. Third, it was left at the discretion of each endoscopist who performed the SC whether to switch to another standard endoscope (e.g., pediatric colonoscope or gastroscope), to use the stiffness function (if available), or to use fluoroscopy or scope guide, and when to stop the SC if further attempts were estimated to be potentially harmful. There was no predetermined time limit to achieve cecal intubation. Therefore, this decision was subjective and not directly reproducible, presenting another selection bias. However, the endoscopists were very experienced ([10 years), and thus, their decisions to break off an incomplete colonoscopy could be trusted. Finally, we did not randomize patients for either repeat SC, SBC, or double-balloonassisted colonoscopy. As mentioned above, the latter technique was not longer available at our institution since 2007. In conclusion, this prospective patient cohort study with 100 patients shows that single-balloon colonoscopy has a very high success rate and is safe. A significant diagnostic and therapeutic gain in the right colon justifies additional procedure time. This appears to be a legitimate method for use in selected patients with previous incomplete colonoscopy. A controlled randomized study is planned to more clearly determine its role. Acknowledgments We wish to thank the statistician Professor Hanno Ulmer, as well as Mrs. Meltem Yilmaz, Mrs. Michela Bazzeghini, and Mr. Matthias Meyenberger for their extraordinary professional technical support. Compliance with ethical standards Disclosures Drs. Michael Christian Sulz, Remus Frei, Gian-Marco Semadeni, Mikael Sawatzki, Jan Borovicka, and Christa Meyenberger have no conflicts of interest or financial ties to disclose.
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and Other Interventional Techniques
The role of single-balloon colonoscopy for patients with previous incomplete standard colonoscopy: Is it worth doing it? Michael Christian Sulz1 • Remus Frei1 • Gian-Marco Semadeni1 • Mikael Sawatzki1 Jan Borovicka1 • Christa Meyenberger1
•
Received: 7 February 2015 / Accepted: 2 July 2015 Ó Springer Science+Business Media New York 2015
Abstract Background The rate of cecal intubation is a well-recognized quality measure of successful colonoscopy. Infrequently, the standard colonoscopy techniques fail to achieve complete examination. The role of single-balloon overtube-assisted colonoscopy (SBC) in these situations has only been sparsely studied. This prospective singlecenter study aimed to investigate the technical success (rate of cecal intubation) and the diagnostic gain of SBC. Methods The study recruited consecutive patients with previous incomplete standard colonoscopy who were admitted for SBC at our tertiary center in Eastern Switzerland between February 2008 and October 2014. The primary outcome was defined as successful cecal intubation. Data on patient characteristics, indication, technical details of procedure, and outcome were collected prospectively. The Olympus enteroscope SIF-Q180 was used. Results The study included 100 consecutive patients (median age 70 years; range 38–87 years; 54 % female) who were examined using a single-balloon overtube-assisted technique. The cecal intubation rate was 98 % (98/ 100). The median time of total procedure was 54 min (range 15–119 min); the median time to reach the cecal pole was 27.5 min (range 4–92 min). Passage of the sigmoid colon was not possible in two cases with a fixed, angulated sigmoid colon. The diagnostic gain was 21 % regarding adenomatous polyps in the right colon. The
& Michael Christian Sulz [email protected] 1
Division of Gastroenterology and Hepatology, Kantonsspital St. Gallen, Rorschacherstrasse 95, 9007 St. Gallen, Switzerland
complication rate was 2 % (2/100, minor) without need for surgery. Conclusions This prospective patient cohort study shows that single-balloon colonoscopy is a safe and effective procedure to achieve a complete endoscopic examination in patients with a previous failed standard colonoscopy. A significant diagnostic and therapeutic gain in the right colon justifies additional procedure time. Keywords Single-balloon Colonoscopy Incomplete Cecal intubation The colon can be visualized using a variety of modern radiological cross-sectional imaging techniques (e.g., colonography by computed tomography or magnetic resonance imaging) and noninvasive endoscopy devices (e.g., wireless video capsule colonoscopy). However, standard flexible endoscopy remains the mainstay of colon disease diagnosis because it is the only technique that allows tissue sampling and performing interventions. Moreover, colonoscopy is the most sensitive available examination for colon pathology detection [1]. International guidelines specify a 90 % rate of successfully reaching the cecum as one major quality index for colonoscopy [2]. Despite improvements in endoscopic equipment and sedation methods, endoscopists still fail to achieve cecal intubation in 5–10 % of cases [3, 4]. This is due to a number of demographic and clinical factors, including older age, female gender, low body mass index (BMI), diverticular disease, insufficient colon cleansing, previous abdominal or pelvic surgery, and anatomical reasons (e.g., redundant colon, dolichocolon, and fixed angulation) [5–7]. In the event of incomplete standard colonoscopy (SC), various endoscopic adaptations can be used to improve the
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chances of success—for example, the pediatric colonoscope, variable stiffness colonoscope, colonoscopy with magnetic guidance, and thinner and more flexible gastroscopes. Additionally, accessory overtubes can allow better colonoscope straightening and thus reduce looping. Among patients with previously failed SC, double-balloon-assisted endoscopy has achieved successful cecal intubation in 88–100 % of cases [8–12]. Over recent years, single-balloon overtube-assisted colonoscopy (SBC) has gained attention. However, to date, only a few fairly small case series are available [13–15], and it remains unclear whether it is worthwhile to perform SBC after incomplete SC. One recently published study concluded that achieving a complete colonic evaluation in patients with previous incomplete colonoscopy was worth the effort [16]. Here we present the so far largest prospective singlecenter study of SBC in cases of previous incomplete SC. This study aimed to add to the published experience with this promising technique, to investigate its technical success rate, and to determine the number of relevant findings in the right hemicolon that were recognized due to the additional effort of SBC compared to the previous incomplete SC.
Materials and methods The present series prospectively included consecutive patients who had an incomplete SC and were admitted for SBC between February 2008 and November 2014. Exclusion criteria included pregnancy, age of \18 years, or failure to provide informed consent. The study was performed in the state hospital of St. Gallen, Switzerland, a tertiary referral center with an average annual case volume of 2500 SCs and serving a population of 500,000 inhabitants. The average annual case volume included 70 singleballoon-assisted endoscopies in the upper and lower gastrointestinal tract. This study was approved by the local ethics committee (EKSG/13/164). Previous incomplete standard colonoscopy (SC) All patients previously underwent SC performed either by gastroenterologists with [10 years of experience performing colonoscopies (each [4000 colonoscopies) in local private practices and district hospitals, or by the endoscopy staff at our center. Incomplete SC was defined as failure to intubate the cecum (i.e., without identification of the ileocecal valve and triradiate fold) or cancellation of colonoscopy due to intolerable pain during the procedure despite sedation with propofol and midazolam or pethidine. Causes for incomplete colonoscopy were either a redundant colon where the cecum could not be reached due to
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excessive looping or a tortuous colon or a fixed angulation of the rectosigmoid that could not be passed. When a colonoscopy was performed by a trainee at our center, an experienced fully trained gastroenterologist tried to complete the examination before it was stopped without completion and regarded as failed. It was left at the discretion of each endoscopist who performed the SC whether to switch to another standard endoscope (e.g., pediatric colonoscope or gastroscope), to use the stiffness function (if available), or to use fluoroscopy or scope guide, and when to stop the SC if further attempts were estimated to be potentially harmful. There was no predetermined time limit to achieve cecal intubation. Thereafter, we proceeded directly to SBC without another attempt of SC in our unit. The double-balloon endoscope (DBE) system was not anymore in use at our institution. Single-balloon colonoscopy (SBC) Bowel preparation was achieved using polyethylene glycol (Macrogol; Norgine, Amsterdam, the Netherlands). Three liters was administered one night prior to the procedure, followed by another liter in the morning on the day of the procedure. The procedures were usually performed under conscious sedation with non-anesthesiologist-administered propofol (AstraZeneca AG, Zug, Switzerland). Patients with multi-morbidity and/or American Society of Anesthesiologists (ASA) classification III/IV were evaluated by anesthetists who decided whether to perform monitored anesthesia care or general anesthesia. Healthy patients without suspicion of active bleeding were usually treated as outpatients. SBC was performed with a single-balloon enteroscopy system (Olympus SIF-Q180 with overtube; Olympus, Tokyo, Japan). This extra-long, thin endoscope (200 cm length; 9.2-mm outer diameter) has a 140-degree field of view. The moveable rigid overtube carries an inflatable and deflatable balloon on its top, allowing stabilization and straightening of the colon. SBC was performed using standard practices with a nurse’s assistance. The overtube was backloaded onto the enteroscope, and then, the enteroscope was advanced until the overtube reached the anus. The overtube with the balloon deflated was then generously lubricated and advanced over the endoscope until either significant resistance was met or the overtube reached the tip of the endoscope. Next, the air was suctioned from the colon, and the overtube balloon was inflated. If loops were shown under fluoroscopic control (Fig. 1), the endoscopist grasped and withdrew both the endoscope and balloon overtube, applying gentle torque to reduce the loop (Fig. 2). Subsequently, the endoscope was again maximally advanced, and the process was repeated until reaching the cecum and/or ileum. The examinations
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square test were used to assess significance when comparing categorical variables (e.g., gender). A p value of B0.05 was considered significant. The STATA 12.0 program (StataCorp LP, College Station, Texas, USA) was used for statistical analysis.
Results
Fig. 1 Fluoroscopy during colonoscopy shows fixed loops in the sigmoid colon. The large arrow shows the inflated balloon of the overtube (small arrow pointing to the tip of the overtube)
Fig. 2 Single-balloon overtube-assisted colonoscopy with fluoroscopic guidance. Inlay shows straightened loops after passage of the sigmoid colon
were performed by six endoscopists, including two trainees and four who were experienced in single-balloonassisted endoscopy ([50 procedures). Data were prospectively collected on sex, age, BMI, ASA classification, indication, details of the previous incomplete SC (if applicable), technical details of SBC procedure, and outcome. Statistical analysis Data were analyzed with the use of descriptive statistics. As appropriate, Fisher’s exact test and Pearson’s Chi-
Between February 2008 and November 2014, 100 consecutive patients with a previous incomplete SC underwent colonoscopy with the single-balloon overtube-assisted technique with the aim of complete examination of the colon. The median age was 70 years (age range 38–87 years), 54 % of the patients were female, and the median BMI was 25.2 kg/m2 (BMI range 17.1–49.0 kg/ m2). Table 1 presents details regarding the patient characteristics and technical information about the previous incomplete SC. Out of 100 patients, 45 (60 % female) had a history of previous abdominal and/or pelvic surgery. In 22/100 cases, the endoscopist switched during the initial incomplete SC to a different standard endoscope (54.5 % pediatric colonoscope, 36.5 % gastroscope 36.5 %) without being successful. The main indication for colonoscopy was abdominal pain (18 %) (Table 2). Of the 100 patients, 11 % underwent SBC for colorectal cancer/polyp screening and 6 % for polyp surveillance (Table 2). The technical success rate of SBC was 98 %, with success defined as cecal intubation and recognition of the ileocecal valve and the appendiceal orifice (Table 3). Passage of the sigmoid colon with the SIF-Q180 endoscope was not technically possible in two patients, both of whom had a fixed, angulated sigmoid colon. One of these patients was a female with severe peritoneal carcinomatosis, and the other was a male with extensive diverticulosis. The median duration of the total procedure was 54 min (range 15–119 min), and the median time to reach the cecal pole was 27.5 min (range 4–92 min) (Table 2). In 94/100 patients, SBC was performed under conscious sedation (non-anesthesiologist-administered propofol, alone or in combination with midazolam or pethidine). Only two cases required general anesthesia, and four cases required monitored anesthesia care (Table 2). Two minor complications (2 %) occurred (Table 3). One patient exhibited a single mucosal defect after the polypectomy. The defect was successfully closed with hemoclips, and the patient received prophylactic antibiotics and remained asymptomatic. Another patient suffered from severe abdominal pain and hematochezia after a diagnostic SBC without intervention. Computed tomography results excluded perforation. This outpatient was then admitted for medical observation and was discharged home pain-free after 4 days.
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Table 2 Technical details of single-balloon colonoscopy
Demographic data
Polyp surveillance
Indication, na 6
Number of patients, n
100
Screening for polyps/early colorectal cancer
Age in years, median (range)
70 (38–87)
Positive family history of colorectal cancer
9 4
Sex, female:male
54:46
Anemia
BMI in kg/m2, median (range)
25.2 (17.1–49)
Abdominal pain
ASA [n (%)]
Bleeding
11
18 6
I
46 (46)
Diarrhea
16
II
32 (32)
Other
31
III
22 (22)
Time to cecal pole in minutes, median (range)
IV Number of patients with previous abdominal and/ or pelvic surgery [n (%)], female:male
0 45 (45), 27:18
Ratio in-house/out-of-house incomplete colonoscopies
43:57
Reason for incomplete colonoscopy [n (%)] Loop
55 (55)
Colon elongatum
17 (17)
Descending colon
100
Propofol dosage in mg, median (range) Propofol combined with Midazolam, n Propofol combined with Pethidine, n Propofol dosage in mg, median (range)
28 (28)
Fixed sigma Part of colon reached [n (% females)] Sigmoid colon
54 (15–119)
Use of sedation, n Propofol alone, n
Previous incomplete standard colonoscopy
6 (16.6)
4
General anesthesia, n
2
Total n is [100 due to combination
Table 3 Outcome of single-balloon colonoscopy Technical success (i.e., cecal intubation) [n (%)]
Endoscopes used, n Colonoscope
78
Complications [n (%)]
Pediatric colonoscope
20
Findings (n/100 patients)
2
Patients with any finding Diverticulosis
22 12 (54.5)
Colitis Colorectal cancer
Use of additional aids, overall, n
21
Polyps, (female:male)
5 (24)
Repeat colonoscopies before SBC, overall, n Once
20 18
Twice
2
Total number of polyps, n (right colon/transverse colon/left colon)
The overall rate of findings was 86 % (Table 3). Of the 100 patients, 54 showed a marked diverticulosis and 47 showed at least one polyp within the colon. The overall adenoma detection rate was 34/100, of which 21 patients had adenomas in the right colon, and 9 had adenomas in the transverse colon (Table 3). Nearly all polyps could be removed. One adenocarcinoma was detected in the sigmoid colon. Among the 13 patients who underwent SBC for polyp/colorectal cancer screening, adenomas were detected
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1 47 (22:25) 113 (55/18/38)
Adenomatous polyps Adenoma detection rate, overall Right colon Transverse colon
ASA American Society of Anesthesiologists, BMI body mass index
86/100 54 4
8 (36.5) 2 (9.0)
Scopeguide [n (%)]
2 (2)
2
Switch to gastroscope [n (%)]
16 (76)
98 (98)
Angiodysplasia
Switch to both [n (%)] Fluoroscopy [n (%)]
325 (102–751)
2 (100) 31 (38.7)
Switch to pediatric colonoscope [n (%)]
34 2
61 (63.9)
Right flexure
Switch to other standard endoscope, n
58 369 (100–806)
Monitored anesthesia care, n a
Left flexure
Gastroscope
27.5 (4–92)
Total procedure time in minutes, median (range)
Left colon Adenoma detection rate in patients admitted for polyp/colorectal cancer screening [n (%)]
34/100 21/100 9/100 16/100 6/13 (46.2)
Histology of polyps in the right colon (%) Tubular adenoma
59.3
Tubulovillous adenoma
11.1
Sessile serrated adenoma Hyperplastic polyp
7.4 14.8
Therapy, overall [n (%)]
46 (46)
Polypectomy [n (%)]
45 (97.8)
Argon plasma coagulation [n (%)]
1 (2.2)
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in 6 (46.2 %). Other findings included a few cases of colitis and angiodysplasia (Table 3).
Discussion Here we describe the so far largest prospective singlecenter study of SBC in 100 patients with prior incomplete SC. We reported a high technical success rate of 98 % in this group of selected patients and a 21 % diagnostic gain regarding adenomatous polyps in the right colon. To date, the literature includes only few and relatively small case series investigating this subject [13–15]. Teshima et al. [14] performed 23 SBC in 22 patients with previous incomplete SC and showed a 96 % cecal intubation success rate. May et al. [15] reported a 100 % success rate for SBC in 14 patients who previously underwent a failed SC. As in our present series, these prior case series reported no procedure-related complications. The strength of our study is that the findings of previous studies, namely the feasibility, the high technical success rate of SBC, and the relevant diagnostic gain of completed colonoscopy in patients with previous incomplete colonoscopy could be confirmed with a high sample size. The European Society of Gastrointestinal Endoscopy (ESGE) [17] states that endoscopists should achieve a cecal intubation rate of above 90 %. However, in clinical practice, incomplete colonoscopy is reported in up to 13 % of patients [18]. These failures are related to several factors, including prior abdominal surgery (resulting in adhesions), severe diverticular disease, inadequate bowel cleansing, patient discomfort, low BMI (\18.5 kg/m2), and female gender [18]. Important causes for incomplete colonoscopy are also either a redundant colon where the cecum could not be reached due to excessive looping or a tortuous colon or a fixed angulation of the rectosigmoid that could not be passed. In patients who undergo an incomplete colonoscopy, complete colonic evaluation can be achieved using a variety of techniques. Depending on the local facility, expertise, and habits, the options may include computed tomography or magnetic resonance colonography, as well as video capsule colonoscopy, repeat endoscopy with or without water immersion or cap assistance, or balloon-assisted colonoscopy. The special features of SBC allow the endoscopist to overcome the aforementioned difficult anatomical conditions in patients with previously incomplete SC. The single-balloon enteroscope is very thin and extra-long (200 cm length; 9.2 mm outer diameter) with a high degree of flexibility and mobility suitable in a fixed angulated rectosigmoid. The moveable rigid overtube with the inflatable and deflatable balloon on its top provides the required stabilization and straightening of redundant or tortuous colon. While the inflated balloon stabilizes the
endoscope within the colon, the SB enteroscope is advanced up to 50 cm; thereafter, the overtube with deflated balloon is gently pushed up. This alternating process is repeated until the cecum and/or ileum is reached. As described above, a variety of options exist to achieve complete colonic evaluation. However, it remains unclear whether complete colonoscopy is really needed and what is gained from the extra effort and cost of performing an additional technical procedure. One recent study concluded that it was worth the effort required to achieve a complete colonic evaluation in patients with incomplete colonoscopy [16]. Repeat colonoscopy in 71 patients with previous incomplete colonoscopies revealed 32 lesions (24 tubular adenomas, 4 tubulovillous adenomas, and 4 sessile serrated polyps) in 17 patients (24 %) [16]. In our present study, 47/100 patients had at least one polyp (34/100 patients with adenomatous polyps), among whom 21 patients had adenomatous polyps in the right colon. This high technical success rate and the diagnostic gain associated with complete colonic evaluation certainly appear to legitimize the practice of SBC. However, it may be more cost-effective to repeat SC in these patients rather than to refer them to a tertiary center for SBC, which is less widely available and more expensive. A recently published Canadian study with 90 patients demonstrated that most patients with a previous incomplete colonoscopy can undergo a successful repeat colonoscopy at a tertiary care center, showing a cecal intubation rate of 97 %, mainly utilizing standard preparation, sedation, and patient positioning [19]. In that study, gastroscopes were only used in 6 % of cases and pediatric colonoscopes in 7 %. However, it is difficult to compare their results with those of the present study. The authors of the Canadian study stated that only 33 % of their patients were previously seen by gastroenterologists. In contrast, all of our present patients referred for SBC had previously undergone SC performed by experienced gastroenterologists in private practices, district hospitals, or in our own unit highlighting the selection of difficult colonoscopies in our study. Gawron et al. [20] also demonstrated the success of repeating SC, achieving cecal intubation in 96 of 100 repeated examinations, 83 of which were completed with a standard endoscope (adult or pediatric colonoscope, or gastroscope). In particular, patients with a tortuous colon more frequently had a complete repeat procedure with a standard endoscope that was not used in the prior incomplete procedure [20]. However, data in literature are contradictory. Keswani et al. [13] randomized 30 patients with incomplete SC to either repeat SC or SBC. SBC was successful in 92.9 % and repeat SC only in 50 %. Those failed repeat SC were then switched to SBC, with a success rate of 100 % [13], emphasizing the impact of SBC in some situations.
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Considering the currently available data as well as the additional technical supplies needed for balloon overtubeassisted endoscopy, it may be easier and less expensive to initially repeat the colonoscopy using standard endoscopes, as suggested by Gawron et al. [20]. The use of a gastroscope is recommended in patients with a tortuous colon that could not be reached using a pediatric colonoscope, as is the use of an adult or pediatric colonoscope in patients with a redundant colon [20]. In any situation, it is advised to use water immersion with no or only minimal air insufflation, as this practice is associated with significantly lower use of an external straightener and less frequent patient position changes compared to air insufflation [21]. Our prospective study showed that SBC has a great potential, with an excellent colonoscopy completion rate and very few complications in the hand of skilled endoscopists. However, it might be best to reserve this procedure for really difficult cases after a second failure of SC in a redundant or tortuous colon. Prospective multicenter randomized trials are needed to evaluate the value of balloon-assisted colonoscopy in the event of incomplete colonoscopy in clinical practice. Double-balloon colonoscopy is another balloon overtubeassisted technique, using an overtube with two balloons. Only scarce data are available to compare single-balloon and double-balloon colonoscopy techniques. One randomized controlled trial with only 21 patients (11 single balloon, 10 double balloon) revealed no significant difference between these two balloon techniques; however, the time to cecal intubation was lower in the group with double-balloon colonoscopy [22]. Double-balloon colonoscopy certainly is also a good option in patients with incomplete SC. However, we decided in 2007 to abandon double-balloon-assisted endoscopy due to feasibility reasons. Since then, we performed all balloon-assisted endoscopies in single-balloon technique. In our opinion, double-balloon-assisted endoscopy is technically more elaborate for the staff; especially for colonoscopy, we think that practicing gastroenterologists may find SBC easier to learn and more intuitive than doubleballoon colonoscopy having two balloon cycles. The Olympus SB enteroscope is stiffer than the Fujinon doubleballoon endoscope (Fujinon Inc., Saitama, Japan) which might be especially suitable when passing redundant colon loops. However, local habits, expertise, and availability determine which type of balloon-assisted endoscope system is utilized at a certain facility. Our study has several limitations. First, this study represents the experience of a Swiss tertiary endoscopy center that receives external referrals for SBC only from experienced gastroenterologists in private practices and district hospitals. Therefore, the patients with a previous incomplete SC are a highly selected group. It is difficult to compare our patients with patients from countries where endoscopy is also
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performed by general internists or surgeons. Second, this was a single-center study with a selection bias. Therefore, the results are not easily generalizable to other practice settings and individual endoscopists. However, the sample size was large compared to other case series in which this topic has been investigated. Third, it was left at the discretion of each endoscopist who performed the SC whether to switch to another standard endoscope (e.g., pediatric colonoscope or gastroscope), to use the stiffness function (if available), or to use fluoroscopy or scope guide, and when to stop the SC if further attempts were estimated to be potentially harmful. There was no predetermined time limit to achieve cecal intubation. Therefore, this decision was subjective and not directly reproducible, presenting another selection bias. However, the endoscopists were very experienced ([10 years), and thus, their decisions to break off an incomplete colonoscopy could be trusted. Finally, we did not randomize patients for either repeat SC, SBC, or double-balloonassisted colonoscopy. As mentioned above, the latter technique was not longer available at our institution since 2007. In conclusion, this prospective patient cohort study with 100 patients shows that single-balloon colonoscopy has a very high success rate and is safe. A significant diagnostic and therapeutic gain in the right colon justifies additional procedure time. This appears to be a legitimate method for use in selected patients with previous incomplete colonoscopy. A controlled randomized study is planned to more clearly determine its role. Acknowledgments We wish to thank the statistician Professor Hanno Ulmer, as well as Mrs. Meltem Yilmaz, Mrs. Michela Bazzeghini, and Mr. Matthias Meyenberger for their extraordinary professional technical support. Compliance with ethical standards Disclosures Drs. Michael Christian Sulz, Remus Frei, Gian-Marco Semadeni, Mikael Sawatzki, Jan Borovicka, and Christa Meyenberger have no conflicts of interest or financial ties to disclose.
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