Surg Endosc DOI 10.1007/s00464-014-3974-z
and Other Interventional Techniques
Does ghost ileostomy have a role in the laparoscopic rectal surgery era? A randomized controlled trial Francesco Saverio Mari • Tatiana Di Cesare • Luciano Novi • Marcello Gasparrini • Giammauro Berardi • Giovanni Guglielmo Laracca Andrea Liverani • Antonio Brescia
•
Received: 27 July 2014 / Accepted: 28 October 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Anastomotic leakage following anterior rectal resection is the most important and most commonly faced complication of laparoscopy and open surgery. To prevent this complication, the construction of a preventing stoma is usually adopted. It is not easy to decide whether to construct a protective stoma in patients with a medium risk of anastomotic leakage. In these patients, ghost ileostomy (GI), a pre-stage ileostomy that can be externalized and opened if needed, has proved useful. We conducted a prospective, randomized, controlled study to evaluate the advantages of GI in laparoscopic rectal resection. Methods All patients with surgical indications for laparoscopic rectal resection who were at medium risk for anastomotic leakage from January 2007 to January 2013 were included and were randomly divided in 2 groups. All of the patients were subjected to laparoscopic anterior rectal resection with the performance of GI (group A) or without the construction of any protective stoma (group B). The presence and severity of clinically evident postoperative anastomotic leakage and other postoperative complications and reinterventions were investigated. Results Of the 55 patients allocated to group A, 3 experienced anastomotic leakage compared with 4 in group B. The patients with GI experienced a lower severity of
The manuscript has been reviewed and approved by all of the listed authors, and all of the data presented are previously unpublished. F. S. Mari (&) T. Di Cesare L. Novi M. Gasparrini G. Berardi G. G. Laracca A. Liverani A. Brescia Department of Medical and Surgical Sciences and Translational Medicine, St. Andrea Hospital, School of Medicine and Psychology, Faculty of Medicine and Psychology, Sapienza University of Rome, Via di Grottarossa 1035, 00189 Rome, Italy e-mail: [email protected]
anastomotic leakage and shorter hospitalization compared with the patients in group B. None of the patients with GI and anastomotic leakage required laparotomy to treat the dehiscence. Conclusions The use of GI in laparoscopic rectal resections in patients at medium risk for anastomotic leakage was useful because it allowed for the avoidance of stoma creation in all of the patients, thus reducing the number of stomas performed, improving the quality of life of the patients and preserving, in most cases, the benefits gained by laparoscopy. Keywords Ghost ileostomy Laparoscopic lower rectal resection Anterior rectal resection Anastomotic leak Anastomotic dehiscence
Since its first performance by Jacob in 1991 [1], laparoscopic colorectal surgery has gained increasing acceptance and has been widely applied. Many studies have shown the advantages of minimally invasive colorectal resection in terms of smaller surgical incision sizes, reduced intraoperative bleeding, less postoperative pain, faster recovery of bowel function, less risk of immobilization-related diseases, shorter hospital stays, a more rapid return to daily activities, and improved quality of life [2, 3]. Additionally, with regard to oncological radicality and short- to medium-term survival, laparoscopy has proved as effective as open surgery [4]. Despite technological improvements in surgical equipment and especially in staplers, anastomotic leakage following anterior rectal resection remains the most important and most commonly faced complication, both in laparoscopy and in open surgery. The clinically evident leakage rate after laparoscopic anterior rectal resection has been reported at 3–19 % [5–12].
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Anastomotic leakage has been associated with significant morbidity and mortality rates (12–27 %), and it usually requires re-operation with stoma creation. This need significantly increases the hospitalization length and all of the costs of recovery [6, 8, 13–19]. The role of a temporary protective stoma has long been debated and remains controversial. Some authors have recommended routine use of a temporary stoma to reduce the rate of and morbidity from anastomotic leakage [20, 21]. In contrast, other authors have discouraged the routine use of temporary stomas, preferring selective use. For these authors, a protective stoma is only able to reduce the disastrous clinical consequences of anastomotic leakage and instead increases the burden with stoma-related complications [6, 22]. The routine use of temporary stomas reduces the benefits of the laparoscopic technique and therefore its selective use would be preferable. The difficulties in the selective use of temporary stomas are related to the necessity for effective anastomotic dehiscence risk stratification, which is unavailable today. Many studies have shown that there are many independent variables associated with an increased risk of anastomotic leakage, such as anastomosis height to the anal verge, preoperative neoadjuvant chemo-radiotherapy, body mass index, age, sex, and American Society of Anesthesiologists score (see Table 1) [8, 12, 14, 23–25]. With these variables in mind, it is easy to identify those high-risk patients who would benefit from stoma protection. Additionally, the identification of those patients at low risk for anastomotic leakage and who do not require stomas is simple. In contrast, it is not easy to decide whether to construct a protective stoma in patients with a medium risk of anastomotic leakage. Usually, in these cases, surgeons
Table 1 Risk class of anastomotic dehiscence following anterior rectal resection Risk class
Anastomosis localizationa
Lower risk
Higher than 10 cm
Medium risk
From 10 to 5 cm
Plus 2 or less co-risk factorb
From 10 to 5 cm
Plus neoadiuvant chemoradiotherapy
rely on their experience or follow the directives of their surgical school. In such cases, the possibility of constructing a temporary ileostomy, as needed, or alternatively if no other incisions on the abdomen are desired, can greatly improve the outcomes of patients undergoing laparoscopic anterior rectal resection. Ghost ileostomy (GI) is just a pre-stage ileostomy that at any time can be externalized and opened. This technique, previously described for open surgery, might be even more advantageous in laparoscopy because it does not jeopardize the important benefits that are typical of minimally invasive surgery [26–30]. To evaluate whether GI was truly advantageous in laparoscopy, we conducted a prospective, randomized, controlled study at the Sant’Andrea Hospital in Rome, Italy.
Materials and methods All patients with surgical indications for laparoscopic rectal resection from January 2007 to January 2013 were evaluated to be included in the study. The patients were classified according to the anastomotic leakage stratification risk into 3 groups: low, medium, and high risk (see Table 1). Only patients in the medium-risk group were definitively included in the study. These patients were subjected to laparoscopic anterior rectal resection, and after the anastomosis was performed, they were randomly divided into 2 treatment groups. In the first group, the GI group, GI was performed, while in the second group, the No Stoma group, no protective stoma was constructed. GI was performed at the end of rectal resection and was removed on the fifth to sixth postoperative day if there were no clinical signs of anastomotic dehiscence. Patients with advanced neoplasia (T4) or with indications for intersphincteric resection were preliminarily excluded from the study. Patients in whom the hydro-pneumatic test of anastomosis tightness showed air leakage were subjected to temporary ileostomy and were excluded from the study. Additionally, patients in whom the surgical procedure was intraoperatively modified from standard laparoscopic anterior rectal resection, such as the need for multiorgan resection or for the Hartmann procedure, were excluded from the study.
Plus emergency setting Plus 3 or more co-risk factorb Higher risk a
Lower than 5 cm
Anastomosis height from the anal verge
b
Co-risk factor are: age over 65 years, male sex, BMI higher than 25, American Society of Anaesthesiology score 3 or 4, diabetes mellitus, blood transfusion and operative time longer than 3 h
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Surgical technique The procedure was conducted under general anesthesia with endotracheal intubation. The patients were placed in the supine position and were secured to the operating table with straps to prevent falling during tilting and rotating maneuvers. Nasogastric tubing and a urinary catheter were
Surg Endosc Fig. 1 Ghost ileostomy: a rubber band was passed around the terminal ileum and externalized through the trocaron the right flank (arrow)
placed during all of the procedures. The tube was removed at the end of procedure, and the catheter was usually removed on the first postoperative day. We routinely performed laparoscopic anterior rectal resections using the three-trocar technique (10 mm), eventually placing a fourth trocar in the left flank if needed. The first port was placed in the middle of the xiphoumbilical line, the second port was placed in the middle of umbilico-pubic line, and the third port was inserted into the right flank. For all of the operations, we performed preliminary exploration of the abdominal cavity to evaluate the extent of the tumor and to determine the presence of any contraindications for laparoscopy. The procedure started with division of the gastro-spleno-colic ligament and subsequent mobilization of the left colic flexure, followed by identification and sectioning of the inferior mesenteric vessels at the origin. The procedure continued with complete mobilization of the descending colon and the rectum to obtain a total mesorectal excision. Once we had completed the rectal section, we usually performed a mechanical termino-terminal anastomosis. Once performed, the anastomosis was tested for air leakage with the hydro-pneumatic test, and if no air bubbles were observed, the procedure continued with the execution of the GI. The terminal ileum was identified, and a window in the mesentery was created to pass a rubber band (we usually used a vessel loop) around the intestinal loop (Fig. 1). The rubber band was subsequently exteriorized through the trocar incision in the right flank. The presence and severity of clinically evident postoperative anastomotic leakage according to the definition of the International Study Group of Rectal Cancer was investigated in both groups [31]. Other postoperative complications and re-interventions were also investigated. The study protocol was approved by our local ethics committee and was registered at ClinicalTrials.gov under number NCT01861379.
All of the patients provided informed consent before being included in the study. The patients’ biographical and study data were prospectively recoded in a computerized database. Statistical analysis Preliminary evaluation using a dedicated, sampling-specific software (PASS 2005) established a minimum of 50 patients/group for 1 % significance level and 80 % statistical power. Calculations were derived from the results of the studies of Gulla`, Mori, Cerroni, and Sacchi et al. [26– 29]. The distributions of all of the variables of interest were examined. The data are reported as the frequencies or mean values, as appropriate. The data were compared using Student’s parametric t test and the nonparametric v2 test, as appropriate. Values of p \ 0.05 were considered statistically significant. The data were analyzed using SPSS software, version 17.0 (SPSS, Inc., Chicago, IL, USA).
Results Between January 2007 and January 2013, 143 patients were evaluated for inclusion in this study. Of these patients, 18 were preliminarily excluded for unexpected extended neoplasia (T4), and another 12 patients were excluded because of a need for stoma construction during rectal resection. Another 6 patients were finally excluded because of positivity of the hydro-pneumatic test for air bubbles, which forced us to construct a temporary ileostomy. Finally, 107 patients were included and were randomly (computer-generated) assigned to one of the two groups: 55 to the GI group and 52 to the No Stoma group, in which temporary ileostomy was not performed (Fig. 2). There were 53 men and 54 women, with a mean age of 70 years, and a mean BMI of 29.3 kg/m2. The two groups were homogeneous for age, sex, BMI, risk factors for
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Enrollment Assessed for eligibility (n= 143)
Excluded (n=36) ♦ Unexpected extended neoplasia (T4) (n=18) ♦ Stoma construction during the rectal resection (n= 12) ♦ Positivity of the hydro-pneumatic test for air bubble (n=6)
Randomized (n= 107)
Allocation GI Group Allocated to intervention (n= 55) ♦ Received allocated intervention (n= 55)
No Stoma Group Allocated to intervention (n=52) ♦ Received allocated intervention (n=52)
♦
♦
Did not receive allocated intervention (n= 0)
Did not receive allocated intervention (n= 0)
Follow-Up Lost to follow-up (n= 0)
Lost to follow-up (n= 0)
Discontinued intervention (n= 0)
Discontinued intervention (n=0)
Analysis Analysed (n=55) ♦ Excluded from analysis (n= 0 )
Analysed (n=52) ♦ Excluded from analysis (n= 0)
Fig. 2 CONSORT diagram of the study
anastomotic dehiscence, and cancer staging. The demographic data and indications for surgery are summarized in Table 2. All of the procedures were performed by 4 expert surgeons, who were equally distributed to the two groups. The incidence of clinically evident anastomotic leakage was similar between the two groups (3 in the GI group and 4 in the No Stoma group, p = 0.63). In the group in which GI was performed, temporary ileostomy was performed in all of the cases on the third postoperative day under local anesthesia, without the need for abdominal re-exploration. In 2 of these 3 cases, the procedure was performed in the ward without the need to bring the patients in the operative room. In all of these cases, anastomotic leakage was suspected by the presence of corpusculated and purulent matter in the perianastomotic drainage tube, with increases
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in C-reactive protein and white blood cell count. All patients with the suspect of anastomotic dehiscence were studied with CT scan to exclude abscess or pelvic collection before surgery. In the No Stoma group, a re-intervention was always needed to construct a temporary ileostomy and in 3 cases, these require a laparotomy. In this group, the re-intervention was performed between the third and the fifth postoperative days and in 2 cases with a fecal peritonitis. The patients with GI experienced a lower severity of anastomotic leakage: grade B for all of the patients in the GI group compared with grade C for all of the patients in the No Stoma group. The mean hospital stays were comparable between the two groups (Table 2), but if we considered only the mean
Surg Endosc Table 2 Biographic and study data
GI
No stoma
N
55
52
Sex, (male/female)
26/29
27/25
0.63a
71 (±7.6)
69 (±8.2)
0.42b
BMI, mean (SD), kg/m
29.3 (±2.6)
29.2 (±3.0)
0.40b
Operative time, mean, minutes
185 (±32)
186 (±47)
0.60b
Neoadiuvant chemo-radiotherapy
37
32
0.55a
Emergency setting
6
5
1.0a
ASA score 3–4
7
9
0.59a
Diabetes mellitus
13
16
0.51a
Blood transfusion
14
11
0.65a
Operative time longer than 3 h
41
38
1.0a
I
6
5
1.0a
II III
19 25
22 22
0.43a 0.84a
IV
5
3
0.71a
6.3 (±1.6)
6.6 (±1.7)
0.83b
3 (5.4 %)
4 (7.7 %)
0.63a
Grade B
Grade C
10.7 (±1.1)
16.2 (±2.0)
Age, mean (SD), years 2
p
Risk factors for anastomotic dehiscence
Cancer staging p value is calculated using v testa or T-student testb
2
c
Cancer Staging based on TNM 2010 Classification
d
Severity of the anastomotic leakage was calculated on the basis of the definition of the International Study Group of Rectal Cancer
c
Hospital stay, days Clinical evident anastomotic leak Severity of anastomotic leakage
d
Hospital stay of patients with an anastomotic leak, days
hospitalization of the patients with anastomotic leakage, there was a significantly shorter length of stay in patients with GI (9.3 vs. 16.2 days, respectively, p = 0.01). None of the GI patients experienced complications in the site of the GI.
Discussion Laparoscopic surgery for colorectal resections has proved effective, and it offers significant advantages over open surgery, including smaller surgical incision sizes, reduced intraoperative bleeding, less postoperative pain, faster recovery of bowel function, less risk of immobilizationrelated diseases, shorter hospital stays, a more rapid return to daily activities, and improved quality of life [2, 3]. Laparoscopic colorectal resection has proved comparable to traditional open surgery with regard to oncological radicality and short- and medium-term survival [4]. Recently, laparoscopic anterior rectal resections have also achieved wide acceptance and diffusion, although with a delay compared to colonic resection. Despite the important progress made in the last few decades regarding technical equipment and surgical techniques, clinical anastomotic leakage is one of the most important complications that can occur after low anterior resection for rectal cancer. The clinical leakage rate after
0.01b
anterior rectal resection has ranged from 3 to 19 % [5–12]. Two extensive reviews reported a rate of 11 % [6, 32]. Anastomotic leakage is associated with significant morbidity and mortality rates (12–27 %), frequent need for re-operation with stoma creation, prolonged hospital stays, and increased costs [6, 8, 13–19]. Additionally, the presence of anastomotic leakage seems to be related to diminished survival and increased local recurrence risk after potentially curative rectal resection [33, 34]. The role of a temporary protective stoma has long been debated and remains controversial. Some authors have reported a lower incidence of anastomotic leakage and reduced morbidity in patients with defunctioning stomas and have recommended the routine use of it [20, 21]. Other authors have experienced a similar rate of anastomotic dehiscence in patients with or without temporary stomas, with the unique advantage of reduced disastrous clinical consequences in ostomatous patients [6, 22]. These authors have discouraged the routine use of temporary stomas, which can cause an additional burden due to stoma-related complications. In fact, the presence of a stoma has been correlated with significant morbidity and mortality rates (15–20 and 0.4 %, respectively) and with several specific complications (see Table 2) [16, 35–37]. The presence of a stoma also worsens the quality of life of ostomatous patients and can cause a permanent change in
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body image, with a significant psychological impact [38]. Moreover, stoma reversal can have a significant impact on patients, with a morbidity rate of 17 % and a non-negligible (0.4 %) mortality rate [35]. Furthermore of the patients who have undergone anterior rectal resection with a temporary stoma a percentage from 6 and 20 % will not undergo stoma reversal [36, 37]. This percentage increases to 50 % if we consider only the elderly patients [39]. A selective approach to the use of a defunctioning stoma should be preferred to reduce the morbidity associated with stomas without significantly increasing the risk of disastrous clinical consequences due to anastomotic leakage. As proposed in this study, a careful analysis of risk factors for anastomotic leakage may be useful for identifying those patients at high risk who would benefit from stoma creation during rectal resection. Routine use of temporary stomas in these patients should also be recommended because these patients would not be able to overcome the clinical consequences of dehiscence, such as peritonitis or septic complications. In contrast, in low-risk patients, temporary stomas should be avoided because stoma-related complications are more common and burdensome than the complications due to anastomotic leakage. The risk stratification for anastomotic leakage, however, resulted in the identification of a group of patients at medium risk, in whom the role of temporary stomas has not yet been well defined. Usually, in these cases, the choice for stoma creation is based on the experience of the individual surgeon or on the dictates of each surgical school. In these patients, the use of GI allowed us to forego stoma creation in patients who truly will not benefit from it. GI is easy to perform during a laparoscopic procedure. At the end of the procedure, a rubber band (we simply use a vessel-loop) can easily be passed around the terminal ileal loop and subsequently externalized through the incision of the trocar at the level of the right flank. If needed, loop ileostomy can be easily created by exteriorizing the ileal loop under local anesthesia. As previously reported, GI is a pre-stage ileostomy, its opening is usually easy and rapid to create, and it can minimize fecal peritonitis in cases of leakage [26–30]. Complete and careful monitoring of patients’ clinical parameters is mandatory for the early identification those patients who require ileostomy construction. The evaluation of laboratory parameters, such as C-reactive protein and WBC, was helpful in the identification of these patients without having to wait for the presence of fecal matter in the drains [31]. GI allowed us to avoid subjecting these patients to a second procedure, perhaps postoperative laparotomy for stoma construction. In fact, only 5.4 % (3/55) of the patients required ileal loop exteriorization during the
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postoperative period, and this procedure was performed under local anesthesia, without the need for abdominal laparoscopic or open exploration. In all of these cases, the anastomotic leakage was identified on the third postoperative day, and it was easily treated with stoma construction, antibiotic therapy and irrigation by the drainage tube. In the No Stoma group, the stoma was performed later than in the group GI probably for the need of a certain diagnosis of anastomotic dehiscence to justify a re-intervention. This has led to a worsening of the clinical condition of the patients. In fact, patients with GI experienced a lower severity of anastomotic leakage (grade B) compared with the patients of the No Stoma Group (grade C). Additionally, if we considered only the patients who experienced anastomotic leakage, GI also proved advantageous in terms of shortened postoperative stays compared to the No Stoma group. This is mainly related to the different severity of the anastomotic dehiscence’s complications. Similar results were reported by Gulla` et al., who showed a statistically significant reduction in stoma-related morbidity and hospitalization in patients with GI compared to patients with traditional ileostomy (5.5 vs. 37 %, p = 0.04, and 5.4 vs. 8.3 days, p = 0.0002, respectively). The creation of a stoma usually significantly affects the quality of life of these patients, with psychological implications and severe repercussions on working activity as well [36–38]. The use of GI allows for the avoidance of stoma creation in all patients, thus reducing the number of stomas performed and, as reported by Gulla` et al., improving the quality of life of these patients [27]. Some authors have already suggested the advantage of performing GI in terms of reduced numbers of stomas created and, consequently, decreased numbers of stomarelated complications [26–30]. In these studies, however, rectal resection was almost always performed as open surgery, and this surgical approach tends to minimize the benefits of GI to only the reduction in the number of stomas performed. The use of GI in laparoscopic rectal resections allows for the preservation of the benefits gained by laparoscopy in the majority of patients. In fact, stoma creation or, worse, the need for laparotomic reintervention following anastomotic leakage negates the advantages of laparoscopy in terms of reduced postoperative pain, rapid functional recovery, decreased hospital stays, and improved esthetic appearance.
Conclusion GI was a safe and efficacious technique for avoiding intraoperative stoma creation in patients at medium risk for
Surg Endosc
anastomotic dehiscence. This technique was very helpful in laparoscopic rectal resection because it allowed for the retention of the benefits of laparoscopy and for the creation of stomas only in patients who needed them.
16. 17.
Disclosures Francesco Saverio Mari, Tatiana Di Cesare, Luciano Novi, Marcello Gasparrini, Giammauro Berardi, Giovanni Guglielmo Laracca, Andrea Liverani and Antonio Brescia declare no conflict of interest or financial ties to disclose.
18.
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and Other Interventional Techniques
Does ghost ileostomy have a role in the laparoscopic rectal surgery era? A randomized controlled trial Francesco Saverio Mari • Tatiana Di Cesare • Luciano Novi • Marcello Gasparrini • Giammauro Berardi • Giovanni Guglielmo Laracca Andrea Liverani • Antonio Brescia
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Received: 27 July 2014 / Accepted: 28 October 2014 Ó Springer Science+Business Media New York 2014
Abstract Background Anastomotic leakage following anterior rectal resection is the most important and most commonly faced complication of laparoscopy and open surgery. To prevent this complication, the construction of a preventing stoma is usually adopted. It is not easy to decide whether to construct a protective stoma in patients with a medium risk of anastomotic leakage. In these patients, ghost ileostomy (GI), a pre-stage ileostomy that can be externalized and opened if needed, has proved useful. We conducted a prospective, randomized, controlled study to evaluate the advantages of GI in laparoscopic rectal resection. Methods All patients with surgical indications for laparoscopic rectal resection who were at medium risk for anastomotic leakage from January 2007 to January 2013 were included and were randomly divided in 2 groups. All of the patients were subjected to laparoscopic anterior rectal resection with the performance of GI (group A) or without the construction of any protective stoma (group B). The presence and severity of clinically evident postoperative anastomotic leakage and other postoperative complications and reinterventions were investigated. Results Of the 55 patients allocated to group A, 3 experienced anastomotic leakage compared with 4 in group B. The patients with GI experienced a lower severity of
The manuscript has been reviewed and approved by all of the listed authors, and all of the data presented are previously unpublished. F. S. Mari (&) T. Di Cesare L. Novi M. Gasparrini G. Berardi G. G. Laracca A. Liverani A. Brescia Department of Medical and Surgical Sciences and Translational Medicine, St. Andrea Hospital, School of Medicine and Psychology, Faculty of Medicine and Psychology, Sapienza University of Rome, Via di Grottarossa 1035, 00189 Rome, Italy e-mail: [email protected]
anastomotic leakage and shorter hospitalization compared with the patients in group B. None of the patients with GI and anastomotic leakage required laparotomy to treat the dehiscence. Conclusions The use of GI in laparoscopic rectal resections in patients at medium risk for anastomotic leakage was useful because it allowed for the avoidance of stoma creation in all of the patients, thus reducing the number of stomas performed, improving the quality of life of the patients and preserving, in most cases, the benefits gained by laparoscopy. Keywords Ghost ileostomy Laparoscopic lower rectal resection Anterior rectal resection Anastomotic leak Anastomotic dehiscence
Since its first performance by Jacob in 1991 [1], laparoscopic colorectal surgery has gained increasing acceptance and has been widely applied. Many studies have shown the advantages of minimally invasive colorectal resection in terms of smaller surgical incision sizes, reduced intraoperative bleeding, less postoperative pain, faster recovery of bowel function, less risk of immobilization-related diseases, shorter hospital stays, a more rapid return to daily activities, and improved quality of life [2, 3]. Additionally, with regard to oncological radicality and short- to medium-term survival, laparoscopy has proved as effective as open surgery [4]. Despite technological improvements in surgical equipment and especially in staplers, anastomotic leakage following anterior rectal resection remains the most important and most commonly faced complication, both in laparoscopy and in open surgery. The clinically evident leakage rate after laparoscopic anterior rectal resection has been reported at 3–19 % [5–12].
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Anastomotic leakage has been associated with significant morbidity and mortality rates (12–27 %), and it usually requires re-operation with stoma creation. This need significantly increases the hospitalization length and all of the costs of recovery [6, 8, 13–19]. The role of a temporary protective stoma has long been debated and remains controversial. Some authors have recommended routine use of a temporary stoma to reduce the rate of and morbidity from anastomotic leakage [20, 21]. In contrast, other authors have discouraged the routine use of temporary stomas, preferring selective use. For these authors, a protective stoma is only able to reduce the disastrous clinical consequences of anastomotic leakage and instead increases the burden with stoma-related complications [6, 22]. The routine use of temporary stomas reduces the benefits of the laparoscopic technique and therefore its selective use would be preferable. The difficulties in the selective use of temporary stomas are related to the necessity for effective anastomotic dehiscence risk stratification, which is unavailable today. Many studies have shown that there are many independent variables associated with an increased risk of anastomotic leakage, such as anastomosis height to the anal verge, preoperative neoadjuvant chemo-radiotherapy, body mass index, age, sex, and American Society of Anesthesiologists score (see Table 1) [8, 12, 14, 23–25]. With these variables in mind, it is easy to identify those high-risk patients who would benefit from stoma protection. Additionally, the identification of those patients at low risk for anastomotic leakage and who do not require stomas is simple. In contrast, it is not easy to decide whether to construct a protective stoma in patients with a medium risk of anastomotic leakage. Usually, in these cases, surgeons
Table 1 Risk class of anastomotic dehiscence following anterior rectal resection Risk class
Anastomosis localizationa
Lower risk
Higher than 10 cm
Medium risk
From 10 to 5 cm
Plus 2 or less co-risk factorb
From 10 to 5 cm
Plus neoadiuvant chemoradiotherapy
rely on their experience or follow the directives of their surgical school. In such cases, the possibility of constructing a temporary ileostomy, as needed, or alternatively if no other incisions on the abdomen are desired, can greatly improve the outcomes of patients undergoing laparoscopic anterior rectal resection. Ghost ileostomy (GI) is just a pre-stage ileostomy that at any time can be externalized and opened. This technique, previously described for open surgery, might be even more advantageous in laparoscopy because it does not jeopardize the important benefits that are typical of minimally invasive surgery [26–30]. To evaluate whether GI was truly advantageous in laparoscopy, we conducted a prospective, randomized, controlled study at the Sant’Andrea Hospital in Rome, Italy.
Materials and methods All patients with surgical indications for laparoscopic rectal resection from January 2007 to January 2013 were evaluated to be included in the study. The patients were classified according to the anastomotic leakage stratification risk into 3 groups: low, medium, and high risk (see Table 1). Only patients in the medium-risk group were definitively included in the study. These patients were subjected to laparoscopic anterior rectal resection, and after the anastomosis was performed, they were randomly divided into 2 treatment groups. In the first group, the GI group, GI was performed, while in the second group, the No Stoma group, no protective stoma was constructed. GI was performed at the end of rectal resection and was removed on the fifth to sixth postoperative day if there were no clinical signs of anastomotic dehiscence. Patients with advanced neoplasia (T4) or with indications for intersphincteric resection were preliminarily excluded from the study. Patients in whom the hydro-pneumatic test of anastomosis tightness showed air leakage were subjected to temporary ileostomy and were excluded from the study. Additionally, patients in whom the surgical procedure was intraoperatively modified from standard laparoscopic anterior rectal resection, such as the need for multiorgan resection or for the Hartmann procedure, were excluded from the study.
Plus emergency setting Plus 3 or more co-risk factorb Higher risk a
Lower than 5 cm
Anastomosis height from the anal verge
b
Co-risk factor are: age over 65 years, male sex, BMI higher than 25, American Society of Anaesthesiology score 3 or 4, diabetes mellitus, blood transfusion and operative time longer than 3 h
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Surgical technique The procedure was conducted under general anesthesia with endotracheal intubation. The patients were placed in the supine position and were secured to the operating table with straps to prevent falling during tilting and rotating maneuvers. Nasogastric tubing and a urinary catheter were
Surg Endosc Fig. 1 Ghost ileostomy: a rubber band was passed around the terminal ileum and externalized through the trocaron the right flank (arrow)
placed during all of the procedures. The tube was removed at the end of procedure, and the catheter was usually removed on the first postoperative day. We routinely performed laparoscopic anterior rectal resections using the three-trocar technique (10 mm), eventually placing a fourth trocar in the left flank if needed. The first port was placed in the middle of the xiphoumbilical line, the second port was placed in the middle of umbilico-pubic line, and the third port was inserted into the right flank. For all of the operations, we performed preliminary exploration of the abdominal cavity to evaluate the extent of the tumor and to determine the presence of any contraindications for laparoscopy. The procedure started with division of the gastro-spleno-colic ligament and subsequent mobilization of the left colic flexure, followed by identification and sectioning of the inferior mesenteric vessels at the origin. The procedure continued with complete mobilization of the descending colon and the rectum to obtain a total mesorectal excision. Once we had completed the rectal section, we usually performed a mechanical termino-terminal anastomosis. Once performed, the anastomosis was tested for air leakage with the hydro-pneumatic test, and if no air bubbles were observed, the procedure continued with the execution of the GI. The terminal ileum was identified, and a window in the mesentery was created to pass a rubber band (we usually used a vessel loop) around the intestinal loop (Fig. 1). The rubber band was subsequently exteriorized through the trocar incision in the right flank. The presence and severity of clinically evident postoperative anastomotic leakage according to the definition of the International Study Group of Rectal Cancer was investigated in both groups [31]. Other postoperative complications and re-interventions were also investigated. The study protocol was approved by our local ethics committee and was registered at ClinicalTrials.gov under number NCT01861379.
All of the patients provided informed consent before being included in the study. The patients’ biographical and study data were prospectively recoded in a computerized database. Statistical analysis Preliminary evaluation using a dedicated, sampling-specific software (PASS 2005) established a minimum of 50 patients/group for 1 % significance level and 80 % statistical power. Calculations were derived from the results of the studies of Gulla`, Mori, Cerroni, and Sacchi et al. [26– 29]. The distributions of all of the variables of interest were examined. The data are reported as the frequencies or mean values, as appropriate. The data were compared using Student’s parametric t test and the nonparametric v2 test, as appropriate. Values of p \ 0.05 were considered statistically significant. The data were analyzed using SPSS software, version 17.0 (SPSS, Inc., Chicago, IL, USA).
Results Between January 2007 and January 2013, 143 patients were evaluated for inclusion in this study. Of these patients, 18 were preliminarily excluded for unexpected extended neoplasia (T4), and another 12 patients were excluded because of a need for stoma construction during rectal resection. Another 6 patients were finally excluded because of positivity of the hydro-pneumatic test for air bubbles, which forced us to construct a temporary ileostomy. Finally, 107 patients were included and were randomly (computer-generated) assigned to one of the two groups: 55 to the GI group and 52 to the No Stoma group, in which temporary ileostomy was not performed (Fig. 2). There were 53 men and 54 women, with a mean age of 70 years, and a mean BMI of 29.3 kg/m2. The two groups were homogeneous for age, sex, BMI, risk factors for
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Enrollment Assessed for eligibility (n= 143)
Excluded (n=36) ♦ Unexpected extended neoplasia (T4) (n=18) ♦ Stoma construction during the rectal resection (n= 12) ♦ Positivity of the hydro-pneumatic test for air bubble (n=6)
Randomized (n= 107)
Allocation GI Group Allocated to intervention (n= 55) ♦ Received allocated intervention (n= 55)
No Stoma Group Allocated to intervention (n=52) ♦ Received allocated intervention (n=52)
♦
♦
Did not receive allocated intervention (n= 0)
Did not receive allocated intervention (n= 0)
Follow-Up Lost to follow-up (n= 0)
Lost to follow-up (n= 0)
Discontinued intervention (n= 0)
Discontinued intervention (n=0)
Analysis Analysed (n=55) ♦ Excluded from analysis (n= 0 )
Analysed (n=52) ♦ Excluded from analysis (n= 0)
Fig. 2 CONSORT diagram of the study
anastomotic dehiscence, and cancer staging. The demographic data and indications for surgery are summarized in Table 2. All of the procedures were performed by 4 expert surgeons, who were equally distributed to the two groups. The incidence of clinically evident anastomotic leakage was similar between the two groups (3 in the GI group and 4 in the No Stoma group, p = 0.63). In the group in which GI was performed, temporary ileostomy was performed in all of the cases on the third postoperative day under local anesthesia, without the need for abdominal re-exploration. In 2 of these 3 cases, the procedure was performed in the ward without the need to bring the patients in the operative room. In all of these cases, anastomotic leakage was suspected by the presence of corpusculated and purulent matter in the perianastomotic drainage tube, with increases
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in C-reactive protein and white blood cell count. All patients with the suspect of anastomotic dehiscence were studied with CT scan to exclude abscess or pelvic collection before surgery. In the No Stoma group, a re-intervention was always needed to construct a temporary ileostomy and in 3 cases, these require a laparotomy. In this group, the re-intervention was performed between the third and the fifth postoperative days and in 2 cases with a fecal peritonitis. The patients with GI experienced a lower severity of anastomotic leakage: grade B for all of the patients in the GI group compared with grade C for all of the patients in the No Stoma group. The mean hospital stays were comparable between the two groups (Table 2), but if we considered only the mean
Surg Endosc Table 2 Biographic and study data
GI
No stoma
N
55
52
Sex, (male/female)
26/29
27/25
0.63a
71 (±7.6)
69 (±8.2)
0.42b
BMI, mean (SD), kg/m
29.3 (±2.6)
29.2 (±3.0)
0.40b
Operative time, mean, minutes
185 (±32)
186 (±47)
0.60b
Neoadiuvant chemo-radiotherapy
37
32
0.55a
Emergency setting
6
5
1.0a
ASA score 3–4
7
9
0.59a
Diabetes mellitus
13
16
0.51a
Blood transfusion
14
11
0.65a
Operative time longer than 3 h
41
38
1.0a
I
6
5
1.0a
II III
19 25
22 22
0.43a 0.84a
IV
5
3
0.71a
6.3 (±1.6)
6.6 (±1.7)
0.83b
3 (5.4 %)
4 (7.7 %)
0.63a
Grade B
Grade C
10.7 (±1.1)
16.2 (±2.0)
Age, mean (SD), years 2
p
Risk factors for anastomotic dehiscence
Cancer staging p value is calculated using v testa or T-student testb
2
c
Cancer Staging based on TNM 2010 Classification
d
Severity of the anastomotic leakage was calculated on the basis of the definition of the International Study Group of Rectal Cancer
c
Hospital stay, days Clinical evident anastomotic leak Severity of anastomotic leakage
d
Hospital stay of patients with an anastomotic leak, days
hospitalization of the patients with anastomotic leakage, there was a significantly shorter length of stay in patients with GI (9.3 vs. 16.2 days, respectively, p = 0.01). None of the GI patients experienced complications in the site of the GI.
Discussion Laparoscopic surgery for colorectal resections has proved effective, and it offers significant advantages over open surgery, including smaller surgical incision sizes, reduced intraoperative bleeding, less postoperative pain, faster recovery of bowel function, less risk of immobilizationrelated diseases, shorter hospital stays, a more rapid return to daily activities, and improved quality of life [2, 3]. Laparoscopic colorectal resection has proved comparable to traditional open surgery with regard to oncological radicality and short- and medium-term survival [4]. Recently, laparoscopic anterior rectal resections have also achieved wide acceptance and diffusion, although with a delay compared to colonic resection. Despite the important progress made in the last few decades regarding technical equipment and surgical techniques, clinical anastomotic leakage is one of the most important complications that can occur after low anterior resection for rectal cancer. The clinical leakage rate after
0.01b
anterior rectal resection has ranged from 3 to 19 % [5–12]. Two extensive reviews reported a rate of 11 % [6, 32]. Anastomotic leakage is associated with significant morbidity and mortality rates (12–27 %), frequent need for re-operation with stoma creation, prolonged hospital stays, and increased costs [6, 8, 13–19]. Additionally, the presence of anastomotic leakage seems to be related to diminished survival and increased local recurrence risk after potentially curative rectal resection [33, 34]. The role of a temporary protective stoma has long been debated and remains controversial. Some authors have reported a lower incidence of anastomotic leakage and reduced morbidity in patients with defunctioning stomas and have recommended the routine use of it [20, 21]. Other authors have experienced a similar rate of anastomotic dehiscence in patients with or without temporary stomas, with the unique advantage of reduced disastrous clinical consequences in ostomatous patients [6, 22]. These authors have discouraged the routine use of temporary stomas, which can cause an additional burden due to stoma-related complications. In fact, the presence of a stoma has been correlated with significant morbidity and mortality rates (15–20 and 0.4 %, respectively) and with several specific complications (see Table 2) [16, 35–37]. The presence of a stoma also worsens the quality of life of ostomatous patients and can cause a permanent change in
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body image, with a significant psychological impact [38]. Moreover, stoma reversal can have a significant impact on patients, with a morbidity rate of 17 % and a non-negligible (0.4 %) mortality rate [35]. Furthermore of the patients who have undergone anterior rectal resection with a temporary stoma a percentage from 6 and 20 % will not undergo stoma reversal [36, 37]. This percentage increases to 50 % if we consider only the elderly patients [39]. A selective approach to the use of a defunctioning stoma should be preferred to reduce the morbidity associated with stomas without significantly increasing the risk of disastrous clinical consequences due to anastomotic leakage. As proposed in this study, a careful analysis of risk factors for anastomotic leakage may be useful for identifying those patients at high risk who would benefit from stoma creation during rectal resection. Routine use of temporary stomas in these patients should also be recommended because these patients would not be able to overcome the clinical consequences of dehiscence, such as peritonitis or septic complications. In contrast, in low-risk patients, temporary stomas should be avoided because stoma-related complications are more common and burdensome than the complications due to anastomotic leakage. The risk stratification for anastomotic leakage, however, resulted in the identification of a group of patients at medium risk, in whom the role of temporary stomas has not yet been well defined. Usually, in these cases, the choice for stoma creation is based on the experience of the individual surgeon or on the dictates of each surgical school. In these patients, the use of GI allowed us to forego stoma creation in patients who truly will not benefit from it. GI is easy to perform during a laparoscopic procedure. At the end of the procedure, a rubber band (we simply use a vessel-loop) can easily be passed around the terminal ileal loop and subsequently externalized through the incision of the trocar at the level of the right flank. If needed, loop ileostomy can be easily created by exteriorizing the ileal loop under local anesthesia. As previously reported, GI is a pre-stage ileostomy, its opening is usually easy and rapid to create, and it can minimize fecal peritonitis in cases of leakage [26–30]. Complete and careful monitoring of patients’ clinical parameters is mandatory for the early identification those patients who require ileostomy construction. The evaluation of laboratory parameters, such as C-reactive protein and WBC, was helpful in the identification of these patients without having to wait for the presence of fecal matter in the drains [31]. GI allowed us to avoid subjecting these patients to a second procedure, perhaps postoperative laparotomy for stoma construction. In fact, only 5.4 % (3/55) of the patients required ileal loop exteriorization during the
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postoperative period, and this procedure was performed under local anesthesia, without the need for abdominal laparoscopic or open exploration. In all of these cases, the anastomotic leakage was identified on the third postoperative day, and it was easily treated with stoma construction, antibiotic therapy and irrigation by the drainage tube. In the No Stoma group, the stoma was performed later than in the group GI probably for the need of a certain diagnosis of anastomotic dehiscence to justify a re-intervention. This has led to a worsening of the clinical condition of the patients. In fact, patients with GI experienced a lower severity of anastomotic leakage (grade B) compared with the patients of the No Stoma Group (grade C). Additionally, if we considered only the patients who experienced anastomotic leakage, GI also proved advantageous in terms of shortened postoperative stays compared to the No Stoma group. This is mainly related to the different severity of the anastomotic dehiscence’s complications. Similar results were reported by Gulla` et al., who showed a statistically significant reduction in stoma-related morbidity and hospitalization in patients with GI compared to patients with traditional ileostomy (5.5 vs. 37 %, p = 0.04, and 5.4 vs. 8.3 days, p = 0.0002, respectively). The creation of a stoma usually significantly affects the quality of life of these patients, with psychological implications and severe repercussions on working activity as well [36–38]. The use of GI allows for the avoidance of stoma creation in all patients, thus reducing the number of stomas performed and, as reported by Gulla` et al., improving the quality of life of these patients [27]. Some authors have already suggested the advantage of performing GI in terms of reduced numbers of stomas created and, consequently, decreased numbers of stomarelated complications [26–30]. In these studies, however, rectal resection was almost always performed as open surgery, and this surgical approach tends to minimize the benefits of GI to only the reduction in the number of stomas performed. The use of GI in laparoscopic rectal resections allows for the preservation of the benefits gained by laparoscopy in the majority of patients. In fact, stoma creation or, worse, the need for laparotomic reintervention following anastomotic leakage negates the advantages of laparoscopy in terms of reduced postoperative pain, rapid functional recovery, decreased hospital stays, and improved esthetic appearance.
Conclusion GI was a safe and efficacious technique for avoiding intraoperative stoma creation in patients at medium risk for
Surg Endosc
anastomotic dehiscence. This technique was very helpful in laparoscopic rectal resection because it allowed for the retention of the benefits of laparoscopy and for the creation of stomas only in patients who needed them.
16. 17.
Disclosures Francesco Saverio Mari, Tatiana Di Cesare, Luciano Novi, Marcello Gasparrini, Giammauro Berardi, Giovanni Guglielmo Laracca, Andrea Liverani and Antonio Brescia declare no conflict of interest or financial ties to disclose.
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19.
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