International Journal of Surgery 20 (2015) 153e157
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Transumbilical Roux-en-Y gastric bypass in morbidly obese patients: A systematic review Ilias P. Doulamis a, Konstantinos P. Economopoulos a, b, * a b
Society of Junior Doctors, Athens, Greece Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
h i g h l i g h t s SILS RYGB leads to better cosmetic results. The higher complication rate of SILS RYGB may be an obstacle. Further research is required in order to make substantial conclusions.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 12 February 2015 Received in revised form 31 May 2015 Accepted 28 June 2015 Available online 10 July 2015
Background: Transumbilical single-incision Roux-en-Y gastric bypass constitutes a delicate technique of the conventional laparoscopic approach, which is the gold standard for the treatment of obesity. Methods: In order to investigate its efficacy and feasibility, PubMed was searched up to April 25th, 2015. Ten studies reporting on 247 patients with a mean age of 37.3 years were eligible. Results: Mean preoperative Body Mass Index was 42.4 kg/m2. Most common comorbidities were diabetes and dyslipidemia. Mean operative time was 128.5 min and mean length of hospital stay was 3.3 days. No conversions to open surgery were reported. Conclusion: Clinical outcomes of the transumbilical Roux-en-Y gastric bypass appear to be comparable with those of the conventional laparoscopic one. However, more trials are necessary to elucidate all of its aspects. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Keywords: Transumbilical Single-incision Roux-en-Y gastric bypass
1. Introduction Obesity and its complications constitute an epidemic which imparts a significant burden on population morbidity and mortality worldwide [1]. Bariatric surgery is considered as the gold standard for the treatment of morbid obesity, since it exhibits better results than non-surgical interventions [2]. Roux-en-Y gastric bypass (RYGB) remains the gold standard procedure for over a decade, with 75% of RYGB procedures done laparoscopically [3,4]. The laparoscopic approach has more to offer than the traditional open approach to both the patient and the surgeon. Minimized blood loss, low complication rate, less postoperative pain and short length of hospital stay are some of the benefits of the laparoscopic approach [5,6]. However, conventional laparoscopic Roux-en-Y
gastric bypass (LRYGB) requires five to seven abdominal incisions and may be associated with a poor cosmetic outcome for the patient [7]. Recently, a more cosmetic-friendly surgical technique has been proposed. In the single incision laparoscopic surgery (SILS) the surgeon utilizes a natural orifice, the umbilicus [8]. Through a single umbilical incision the same operation is performed with better cosmetic results since no or few minor additional incisions are made on the abdominal wall and no postoperative scar is visible [9]. However, there is still lack of comprehensive evidence regarding the efficacy, the complications and other specific characteristics of SILS-RYGB. With this systematic review we aim to perform a thorough search of the published available data, in order to elucidate all aspects of this novel technique. 2. Methods
* Corresponding author. Department of Surgery, Massachusetts General Hospital, Harvard Medical School, 101 Merrimac street, Boston, MA, 02114, USA. E-mail addresses: [email protected] (I.P. Doulamis), keconomopoulos@mgh. harvard.edu (K.P. Economopoulos).
2.1. Search strategy and article selection The systematic review was conducted in accordance with the
http://dx.doi.org/10.1016/j.ijsu.2015.06.077 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
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I.P. Doulamis, K.P. Economopoulos / International Journal of Surgery 20 (2015) 153e157
Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines and in line with the protocol agreed by all authors [10]. The following MeSH terms were used for this search in all possible combinations: “single incision laparoscopic surgery (SILS)”, “gastric bypass”, “single incision”, “single port access”, “single incision transumbilical (SITU)”. Pubmed database and Cochrane library were used. Original studies reporting on outcomes following treatment of obesity and its complications with SILS-RYGB were considered eligible for this systematic review. The selection process excluded studies reporting on: 1) animal models, 2) patients treated with more than three incisions, 3) other bariatric operations than Roux-en-Y gastric bypass. In addition, all references of relevant reviews and eligible articles were hand-searched for potentially missed eligible studies. Articles in language other than English were excluded. Two independent reviewers extracted the data from the included studies, discrepancies were discussed and consensus was reached. The methodological quality of all included studies was assessed using the NewcastleeOttawa Quality Assessment Scale (NOS) of nonrandomized studies. 2.2. Data extraction For each of the eligible studies data regarding the study characteristics (study center, study period, type of study), demographic characteristics (number of patients, age, gender, Body Mass Index (BMI)), comorbidities (eg. diabetes, sleep apnea, hypertension), American Society of Anesthesiologists (ASA) status [11] and history of prior abdominal operations of the studied population were extracted. Additional perioperative data were also extracted. Specifically, data related to the surgical technique used (i.e. route of access, number of trocars used, gastrojejunal anastomosis, jejunojejunal anastomosis, enterotomy closure), complications (i.e. conversion to open surgery, bleeding, respiratory or renal failure, anastomotic leak or stricture, adding trocar) and surgical outcomes (i.e. mortality, mean length of hospital stay, reoperations, mean weight and BMI loss, reversion of pre-existing comorbidities) were extracted from the eligible studies. 2.3. Statistical analysis All data extracted from eligible studies were tabulated and the outcomes were analyzed cumulatively. A descriptive approach was attempted in all parameters. No further statistical analysis was performed. 3. Results 3.1. Article selection and patient demographics The flow diagram of the search of this systematic review is shown in Fig. 1. In total, ten studies met the inclusion criteria and reported on 247 patients who had undergone SILS-RYGB for the treatment of obesity [5,7,9,12e18]. General characteristics of the eligible studies and patient demographics are summarized in Table 1. Six of the eligible studies were prospective cohort studies of relatively low quality (were characterized on average by six stars in the Newcastle Ottawa scale) [5,7,13,14,16,18], while the rest were either case report (n ¼ 2) [9,15] or case series (n ¼ 2) [12,17]. The mean age of the patients was 37.3 years (range, 19e55 years), and 79.4% (n ¼ 196) of them were female. Preoperative BMI was ranging from 35.3 to 55.3 kg/m2, with a mean value of 42.4 kg/m2. In respect of the ASA Physical Status classification system, 30.1% (22/73) of the patients were classified as ASA I or II, while the rest were divided into ASA III and IV (29/73 and 22/73, respectively). As far as
previous surgical operations are concerned, one patient underwent a cosmetic operation on the abdominal area, six patients had a cholecystectomy, two patients a hysterectomy (with a C-section) and one patient had a ventricular hernia repair. The most common comorbidities of the patients were dyslipidemia (22.8%, 32/154), diabetes mellitus (16.2%, 25/154), arthritis (15.6%, 24/154) and hypertension (16.8%, 26/154). 3.2. Surgical technique, perioperative outcomes, morbidity and mortality Specific characteristics of the surgical technique are summarized in Table 2. Gastrojejunal anastomosis was performed in all patients, while jejunojejunal anastomosis was performed in 94.3% of them (233/247). The enterotomy closure was hand sewn in 40% of the patients (99/247) and in the rest of them it was carried out with a stapler (134/247) or with the use of Endo Stitch™ (14/247). No need for an additional trocar/incision and nor conversion to open surgery was reported in any of the included studies, except for one patient, in which conversion to conventional laparoscopic RYGB was required. Re-operation was required in 1.2% of the surgical patients (n ¼ 3). The mean operative time was 128.5 min (range, 60e240 min) and the postoperative mean hospital stay was 3.3 days (range, 1e9 days). The mortality rate was restricted to zero. There were no major postoperative complications, except for 1 patient with respiratory failure, 3 patients with anastomotic leak or stricture and 3 patients with focal infection of the incisional wound (Table 3). 3.3. Follow-up Mean follow-up period, in a subtotal of 128 patients, was 10 months. As far as the effectiveness of the bariatric operations is concerned, data was reported only for 85 patients, who exhibited 44% weight loss on average. 4. Discussion This systematic review summarizes the available data regarding SILS-RYGB in bariatric patients. Six of the available studies identified were prospective cohort of relatively low quality. The rest of the included studies were either case reports or case series. In 2009, Saber et al. reported the first successful single port transumbilical laparoscopic RYGB in a 38-year-old female with BMI of 38.7 kg/m2 [9]. No major complications were reported and the patient was discharged from the hospital the first postoperative day. In the 3-month postoperative follow-up period, 18% reduction of the body weight was shown. The following year, Saber et al. published a series of 16 patients who had undergone laparoscopic RYGB through 3 incisions (transumbilical, right upper quadrant, subxiphoid) [17]. Surgical complications were limited to two patients (one with wound infection and one with atrial fibrillation). At the same year, Tacchino et al. published the first prospective cohort study regarding SILS-RYGB using a single port procedure (only one transumbilical incision) in 14 patients [18]. Tacchino et al. reported a 28% reduction of body weight and one patient with obstructive jaundice after a 12-month period. With regard to the access route used in the eligible studies, the transumbilical one was reported in all cases. However, as mentioned above, additional abdominal incisions were also reported in eight studies [5,7,12,14e17,19]. Specifically, a subxiphoid incision was required in 22.5% of the overall patients (n ¼ 191), a left upper quadrant (LUQ) in 12%, a right upper quadrant (RUQ) in 8%, a left lateral abdominal in 52%, an epigastric in 1 patient, while additional incisions are reported in 5 more patients without any
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Fig. 1. PRISMA flow diagram of transumbilical gastric bypass Search term: (single incision OR single port access OR SILS OR SITU) AND gastric bypass.
further details. These differentiations of the incision site are rational, since a solely single incision with the use of multi-access port devices can eliminate the need for additional scars, but it can predispose at the same time to incisional hernias [20]. On the other hand, making one or two extra incisions apart from the main umbilical one, may not require special devices and instruments and it presents less potential for the development of postoperative hernias [21]. It should also be pointed out that somatometric characteristics such as BMI and the distance between the umbilicus and the epigastric area, have to be taken into consideration in order to provide an individualized approach to each patient [12]. The surgical technique per se, did not vary at a great degree within the studies (eg. gastric pouch left, distance from Treitz ligament for anastomosis etc). The only remarkable difference among the studies included in this analysis is the fact that Lee et al. used a stapler to make the enterotomy closure after the jejunojenunal
anastomosis [14], Rogula et al. used and Endo Stitch [5], while the rest surgeons made it hand-sewn. Mean operative time was 128.5 min on average, ranging from 60 min [16] to 240 min [16]. Moreover, surgeons who used only transumbilical access did not seem to exhibit longer operative time than the overall average (134 min, vs 128.5 min, respectively). With regards to major operative complications, Lee et al. reported a 2% anastomotic leak rate and 3 patients required reoperation [14]. Tacchino et al. reported mild pneumonia with pleural effusion and non-obstructive jaundice, which resolved in one week, in one patient [18]. It should be highlighted that no death was reported. Wound complications such as seroma, infection and hernia are frequently seen following SILS [22]. Nonetheless, in SILS-RYGB wound infection was reported only in three cases, while no hernia on the incisional site was mentioned. These outcomes seem
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Table 1 Characteristics of eligible studies and demographic data of the patients. ASA status: American Society of Anesthesiologists Classification System, BMI: Body Mass Index, NOS: NewcastleeOttawa Quality Assessment Scale for cohort studies. Trial ID
Saber 2009 [9] Tacchino 2010 [18] Fernandez 2013 [12] Morales Conde 2013 [7] Marchesini 2013 [15] Huang 2012 [13] Saber 2010 [17] Lee 2012 [14] Pitot 2014 [16] Rogula 2014 [5] Total
Stars in Patients, Mean age ± SD Female, Ottawa n (years) n (%)
Journal
Surg Innov e Obes Surg 4 Obes Surg e Surg Endosc 4 ABCD e Surg Obes Relat Dis 5 Int J Surg e Surg Obes Relat Dis 7 Surg Endosc 7 Obes Surg 10
1 16 3 22 1 40 16 100 34 14 247
34 38.4 34 41 ± 9 50 30.6 ± 7.75 47 34 42.6 48.1 ± 11.3 37.3
1 (100) 16 (100) 3 (100) 21 (95) 1 (100) 36 (90) 12 (75) 70 (70) 24 (70) 12 (86%) 196 (79.4)
Mean preoperative ASA status, n (%) BMI ± SD (kg/m2) 1 2
3
4
38.7 43.5 37.2 42.7 ± 2.3 41 41.1 ± 5.1 42.4 43.2 41.9 40.2 ± 4.6 42.4
1 (100) 14 (87.5) 0 0 0 e 8 (50) e e 6 (43) 29 (40)
0 0 0 e 0 e 22 (100) e 0 1 e e 0 11 e e e e 0 e 22 (30) 12 (66.7)
0 0 1 (33) 0 1 (100) e 4 (25) e e 2 (14) 8 (10.9)
0 2 (12.5) 2 (67) 0 0 e 4 (25) e e 6 (43) 14 (19.5)
Prior abdominal operations
Table 2 Characteristics of the surgical procedure. Trial ID
Access route
Saber 2009 [9] Tacchino 2013 [18] Fernandez 2013 [12] Morales Conde 2013 [7] Marchesini 2013 [15] Huang 2012 [13] Saber 2010 [17]
Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical
Lee 2012 [14]
Transumbilical & left lateral abdominal wall Transumbilical Transumbilical
Pitot 2014 [16] Rogula 2014 [5] Total
Number of trocars used
& subxiphoid & & & &
2 1 3 (87%), 2 (13%) e LUQ incision 4 1 LUQ & subxiphoid 3 2 (86%) LUQ & epigastric 5 2 3 0 RUQ & subxiphoid & 4 2
25 22 30 22 27 29 22
1 16 3 22 1 40 16
(100) (100) (100) (100) (100) (100) (100)
1 2 3 22 1 40 16
(100) (12.5) (100) (100) (100) (100) (100)
3
1
22
100 (100)
100 (100)
2 3
4 (3%) 1 (14%)
10 22
34 (100) 14 (100) 247 (100)
34 (100) 14 (100) 233 (94.3)
much more encouraging than other published data [22]. The effectiveness of SILS-RYGB, in terms of weight loss, was specified in 85 patients. In these cases, a 41% mean weight loss was reported and the mean follow-up time after surgery was 10 months. These results are comparable with those of conventional laparoscopic gastric bypass, however there is a need of studies with a longer follow-up in order to draw more definite conclusions regarding the efficacy of SILS-RYGB [23,24]. At this point, it should be highlighted that SILS-RYGB has a significant learning curve. The surgeon needs to acquire high yield skills and expertise in laparoscopy in order to be able to accomplish such operations. The surgical procedure is much more demanding than the conventional one, since more careful and delicate maneuvers have to be made. While there is no available data regarding the experience of an average surgeon and the efficacy of SILS-RYGB in comparison with
Table 3 Preoperative comorbidities and postoperative complications of patients following single-incision laparoscopic Roux-en-Y gastric bypass surgery. GERD: Gastroesophageal Reflux Disease. Comorbidities
n, (%)
Complications
n, (%)
Arthritis Diabetes mellitus Dyslipidemia Hypertension GERD Sleep apnea syndrome Stress incontinence
24 25 32 26 10 13 5
Anastomotic leak/stricture Bleeding Conversion to open Hernia (incisional/internal) Renal failure Respiratory failure Wound infection
3 (1.2) 0 0 0 0 1 (0.4) 3 (1.2)
(15.6) (16.2) (22.8) (16.8) (6.4) (8.3) (3.2)
Additional Total mm of Surgical technique number transumbilical Gastrojejunal Jejunojenunal Enterotomy closure of incisions trocars anastomosis, anastomosis, (after JJ anastomosis), n (%) n (%) n (technique) 1 (handsewn) 16 (handsewn) 3 (handsewn) 22 (handsewn) 1 (handsewn) 40 (handsewn) 16 (handsewn intracorporeal) 100 (stapler) 34 (stapler) 14 (Endo Stitch)
conventional RYGB, Rogula et al. reported that the former is feasible in selected bariatric patients and that the short term outcomes are comparable between the two groups [5]. Finally, it should be noted that the majority of the patients (79.4%) were women. Many factors (such as having children, been teased for appearance, etc) have been found to be positively related to an interest in cosmetic surgery in females [25]. This may pose a limitation for the generalizability of the findings to the male population. The enhanced aesthetic results of SILS should be taken into consideration as an ameliorating psychological factor for the patient, especially for females. This study has several limitations that should be taken into account before the interpretation of our findings. The eligible studies include the initial experience of surgeons with this relatively new procedure and probably consist of data from selected patients, which makes our results not generalizable to the population overall. The small sample size e and the even smaller number of true SITU operations (104 patients in total) - and the short followup period of the eligible studies are another concern. Moreover, it is precarious to draw certain conclusions regarding the success of the procedures performed, since there is available data on weight loss for only 34% of patients. The heterogeneity among the studies in terms of differences in the surgical technique among surgeons (i.e. number of incisions, access site, different access devices, instruments and overall equipment) is another drawback of this study. On the other hand, the strengths of this study are the systematic approach adopted for the identification of the eligible studies, the detailed data extraction of all included studies, the rating of the
I.P. Doulamis, K.P. Economopoulos / International Journal of Surgery 20 (2015) 153e157
quality of the studies, and the detailed reporting of extracted data. However, it should not be neglected that these reports come from highly skilled surgeons and may not be reproducible by average surgeons.
[2]
5. Conclusion
[4]
It has been demonstrated that SILS-RYGB is a feasible procedure with improved cosmetic results, when compared to conventional techniques. However, the high complication rate casts doubt on the efficacy and safety of this procedure. It is rational that in an attempt to achieve a “reduced port” technique, the clinical outcomes are being endangered at a certain degree. It is yet to be answered whether the risk for a better cosmetic result is acceptable or not by both the health professionals and the overall population. Randomized trials and larger cohort studies with longer follow-up are of paramount importance so as to evaluate and define the role of SILS-RYGB for the bariatric patient. Ethical approval None. Sources of funding None. Author contribution IPD contributed to the literature review, submitted, and drafted the paper. KPE contributed to study conception, design, edited the paper and is guarantor for the manuscript. All authors read and approved the final manuscript.
[3]
[5]
[6]
[7]
[8] [9]
[10]
[11] [12]
[13]
[14]
[15]
[16]
[17]
Conflict of interest None.
[18] [19]
Guarantor [20]
Konstantinos P Economopoulos. [21]
Acknowledgments [22]
None. Appendix A. Supplementary data
[23]
Supplementary data related to this article can be found at http:// dx.doi.org/10.1016/j.ijsu.2015.06.077.
[24]
References
[25]
[1] C. Ricci, M. Gaeta, E. Rausa, Y. Macchitella, L. Bonavina, Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a
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systematic review, meta-analysis and meta-regression on 6,587 patients, Obes. Surg. 24 (2013) 522e528. H. Buchwald, Y. Avidor, E. Braunwald, et al., Bariatric surgery: a systematic review and meta-analysis, JAMA 292 (2004) 1724e1737. M. Martin, A. Beekley, R. Kjorstad, J. Sebesta, Socioeconomic disparities in eligibility and access to bariatric surgery: a national population-based analysis, Surg. Obes. Relat. Dis. 6 (2010) 8e15. P.S. Griffith, D.W. Birch, A.M. Sharma, S. Karmali, Managing complications associated with laparoscopic Roux-en-Y gastric bypass for morbid obesity, Can. J. Surg. 55 (2012) 329e336. T. Rogula, C. Daigle, M. Dua, et al., Laparoscopic bariatric surgery can be performed through a single incision: a comparative study, Obes. Surg. 24 (2014) 1102e1108. S. Giordano, M. Victorzon, Laparoscopic Roux-en-Y gastric bypass is effective and safe in over 55-year-old patients: a comparative analysis, World J. Surg. 38 (2013) 1121e1126. S. Morales-Conde, M. Rubio-Manzanares Dorado, A. Barranco, et al., Singleport Roux-en-Y gastric bypass: toward a less invasive procedure with the same surgical results and a better cosmesis, Surg. Endosc. 27 (2013) 4347e4353. C.K. Huang, Single-incision laparoscopic bariatric surgery, J. Minim. Access Surg. 7 (2011) 99e103. A.A. Saber, T.H. El-Ghazaly, D.B. Minnick, Single port access transumbilical laparoscopic Roux-en-Y gastric bypass using the SILS Port: first reported case, Surg. Innov. 16 (2009) 343e347. A. Liberati, D.G. Altman, J. Tetzlaff, et al., The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration, PLoS Med. 6 (2009) e1000100. A.S.o. Anesthesiologists, ASA Physical Status Classification System, 2008. http://www.asahq.org/clinical/physicalstatus.htm. J.I. Fernandez, C. Ovalle, C. Farias, J. de la Maza, C. Cabrera, Transumbilical laparoscopic Roux-en-Y gastric bypass with hand-sewn gastrojejunal anastomosis, Obes. Surg. 23 (2013) 140e144. C.K. Huang, C.H. Lo, J.Y. Houng, Y.S. Chen, P.H. Lee, Surgical results of singleincision transumbilical laparoscopic Roux-en-Y gastric bypass, Surg. Obes. Relat. Dis. 8 (2012) 201e207. W.J. Lee, J.C. Chen, W.C. Yao, et al., Transumbilical 2-site laparoscopic Rouxen-Y gastric bypass: initial results of 100 cases and comparison with traditional laparoscopic technique, Surg. Obes. Relat. Dis. 8 (2012) 208e213. J.C. Marchesini, J.B. Marchesini, G.A. Baretta, et al., Laparoscopic Roux-en-Y gastric bypass with single transumbilical incisioneGelPoint(R), Arq. Bras. Cir. Dig. 26 (Suppl. 1) (2013) 83e84. D. Pitot, M. Takieddine, Z. Abbassi, et al., Pure transumbilical SILS gastric bypass with mechanical circular gastrojejunal anastomosis feasibility, Surg. Endosc. 28 (2014) 3007e3011. A.A. Saber, M.H. Elgamal, T.H. El-Ghazaly, et al., Three trocar laparoscopic Roux-en-y gastric bypass: a novel technique en route to the single-incision laparoscopic approach, Int. J. Surg. 8 (2010) 131e134. R.M. Tacchino, F. Greco, D. Matera, G. Diflumeri, Single-incision laparoscopic gastric bypass for morbid obesity, Obes. Surg. 20 (2010) 1154e1160. C.K. Huang, J.C. Tsai, C.H. Lo, et al., Preliminary surgical results of singleincision transumbilical laparoscopic bariatric surgery, Obes. Surg. 21 (2011) 391e396. J.E. Varela, Single-site laparoscopic sleeve gastrectomy: preclinical use of a novel multi-access port device, Surg. Innov. 16 (2009) 207e210. A.M. Merchant, M.W. Cook, B.C. White, et al., Transumbilical Gelport access technique for performing single incision laparoscopic surgery (SILS), J. Gastrointest. Surg. 13 (2009) 159e162. C.E. Koh, D.J. Martin, D.J. Cavallucci, G. Becerril-Martinez, C.J. Taylor, On the road to single-site laparoscopic adjustable gastric banding: lessons learned from 60 cases, Surg. Endosc. 25 (2011) 947e953. K.J. Coleman, J. Brookey, Gender and Racial/Ethnic Background Predict Weight Loss after Roux-en-Y Gastric Bypass Independent of Health and Lifestyle Behaviors, Obes. Surg. 24 (2014) 1729e1736. M.K. Kim, W. Kim, H.S. Kwon, et al., Effects of bariatric surgery on metabolic and nutritional parameters in severely obese Korean patients with type 2 diabetes: a prospective 2-year follow up, J. Diabetes Investig. 5 (2014) 221e227. I.M. Javo, T. Sorlie, Psychosocial predictors of an interest in cosmetic surgery among young Norwegian women: a population-based study, Plast. Surg. Nurs. 30 (2010) 180e186.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Transumbilical Roux-en-Y gastric bypass in morbidly obese patients: A systematic review Ilias P. Doulamis a, Konstantinos P. Economopoulos a, b, * a b
Society of Junior Doctors, Athens, Greece Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
h i g h l i g h t s SILS RYGB leads to better cosmetic results. The higher complication rate of SILS RYGB may be an obstacle. Further research is required in order to make substantial conclusions.
a r t i c l e i n f o
a b s t r a c t
Article history: Received 12 February 2015 Received in revised form 31 May 2015 Accepted 28 June 2015 Available online 10 July 2015
Background: Transumbilical single-incision Roux-en-Y gastric bypass constitutes a delicate technique of the conventional laparoscopic approach, which is the gold standard for the treatment of obesity. Methods: In order to investigate its efficacy and feasibility, PubMed was searched up to April 25th, 2015. Ten studies reporting on 247 patients with a mean age of 37.3 years were eligible. Results: Mean preoperative Body Mass Index was 42.4 kg/m2. Most common comorbidities were diabetes and dyslipidemia. Mean operative time was 128.5 min and mean length of hospital stay was 3.3 days. No conversions to open surgery were reported. Conclusion: Clinical outcomes of the transumbilical Roux-en-Y gastric bypass appear to be comparable with those of the conventional laparoscopic one. However, more trials are necessary to elucidate all of its aspects. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Keywords: Transumbilical Single-incision Roux-en-Y gastric bypass
1. Introduction Obesity and its complications constitute an epidemic which imparts a significant burden on population morbidity and mortality worldwide [1]. Bariatric surgery is considered as the gold standard for the treatment of morbid obesity, since it exhibits better results than non-surgical interventions [2]. Roux-en-Y gastric bypass (RYGB) remains the gold standard procedure for over a decade, with 75% of RYGB procedures done laparoscopically [3,4]. The laparoscopic approach has more to offer than the traditional open approach to both the patient and the surgeon. Minimized blood loss, low complication rate, less postoperative pain and short length of hospital stay are some of the benefits of the laparoscopic approach [5,6]. However, conventional laparoscopic Roux-en-Y
gastric bypass (LRYGB) requires five to seven abdominal incisions and may be associated with a poor cosmetic outcome for the patient [7]. Recently, a more cosmetic-friendly surgical technique has been proposed. In the single incision laparoscopic surgery (SILS) the surgeon utilizes a natural orifice, the umbilicus [8]. Through a single umbilical incision the same operation is performed with better cosmetic results since no or few minor additional incisions are made on the abdominal wall and no postoperative scar is visible [9]. However, there is still lack of comprehensive evidence regarding the efficacy, the complications and other specific characteristics of SILS-RYGB. With this systematic review we aim to perform a thorough search of the published available data, in order to elucidate all aspects of this novel technique. 2. Methods
* Corresponding author. Department of Surgery, Massachusetts General Hospital, Harvard Medical School, 101 Merrimac street, Boston, MA, 02114, USA. E-mail addresses: [email protected] (I.P. Doulamis), keconomopoulos@mgh. harvard.edu (K.P. Economopoulos).
2.1. Search strategy and article selection The systematic review was conducted in accordance with the
http://dx.doi.org/10.1016/j.ijsu.2015.06.077 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
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Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines and in line with the protocol agreed by all authors [10]. The following MeSH terms were used for this search in all possible combinations: “single incision laparoscopic surgery (SILS)”, “gastric bypass”, “single incision”, “single port access”, “single incision transumbilical (SITU)”. Pubmed database and Cochrane library were used. Original studies reporting on outcomes following treatment of obesity and its complications with SILS-RYGB were considered eligible for this systematic review. The selection process excluded studies reporting on: 1) animal models, 2) patients treated with more than three incisions, 3) other bariatric operations than Roux-en-Y gastric bypass. In addition, all references of relevant reviews and eligible articles were hand-searched for potentially missed eligible studies. Articles in language other than English were excluded. Two independent reviewers extracted the data from the included studies, discrepancies were discussed and consensus was reached. The methodological quality of all included studies was assessed using the NewcastleeOttawa Quality Assessment Scale (NOS) of nonrandomized studies. 2.2. Data extraction For each of the eligible studies data regarding the study characteristics (study center, study period, type of study), demographic characteristics (number of patients, age, gender, Body Mass Index (BMI)), comorbidities (eg. diabetes, sleep apnea, hypertension), American Society of Anesthesiologists (ASA) status [11] and history of prior abdominal operations of the studied population were extracted. Additional perioperative data were also extracted. Specifically, data related to the surgical technique used (i.e. route of access, number of trocars used, gastrojejunal anastomosis, jejunojejunal anastomosis, enterotomy closure), complications (i.e. conversion to open surgery, bleeding, respiratory or renal failure, anastomotic leak or stricture, adding trocar) and surgical outcomes (i.e. mortality, mean length of hospital stay, reoperations, mean weight and BMI loss, reversion of pre-existing comorbidities) were extracted from the eligible studies. 2.3. Statistical analysis All data extracted from eligible studies were tabulated and the outcomes were analyzed cumulatively. A descriptive approach was attempted in all parameters. No further statistical analysis was performed. 3. Results 3.1. Article selection and patient demographics The flow diagram of the search of this systematic review is shown in Fig. 1. In total, ten studies met the inclusion criteria and reported on 247 patients who had undergone SILS-RYGB for the treatment of obesity [5,7,9,12e18]. General characteristics of the eligible studies and patient demographics are summarized in Table 1. Six of the eligible studies were prospective cohort studies of relatively low quality (were characterized on average by six stars in the Newcastle Ottawa scale) [5,7,13,14,16,18], while the rest were either case report (n ¼ 2) [9,15] or case series (n ¼ 2) [12,17]. The mean age of the patients was 37.3 years (range, 19e55 years), and 79.4% (n ¼ 196) of them were female. Preoperative BMI was ranging from 35.3 to 55.3 kg/m2, with a mean value of 42.4 kg/m2. In respect of the ASA Physical Status classification system, 30.1% (22/73) of the patients were classified as ASA I or II, while the rest were divided into ASA III and IV (29/73 and 22/73, respectively). As far as
previous surgical operations are concerned, one patient underwent a cosmetic operation on the abdominal area, six patients had a cholecystectomy, two patients a hysterectomy (with a C-section) and one patient had a ventricular hernia repair. The most common comorbidities of the patients were dyslipidemia (22.8%, 32/154), diabetes mellitus (16.2%, 25/154), arthritis (15.6%, 24/154) and hypertension (16.8%, 26/154). 3.2. Surgical technique, perioperative outcomes, morbidity and mortality Specific characteristics of the surgical technique are summarized in Table 2. Gastrojejunal anastomosis was performed in all patients, while jejunojejunal anastomosis was performed in 94.3% of them (233/247). The enterotomy closure was hand sewn in 40% of the patients (99/247) and in the rest of them it was carried out with a stapler (134/247) or with the use of Endo Stitch™ (14/247). No need for an additional trocar/incision and nor conversion to open surgery was reported in any of the included studies, except for one patient, in which conversion to conventional laparoscopic RYGB was required. Re-operation was required in 1.2% of the surgical patients (n ¼ 3). The mean operative time was 128.5 min (range, 60e240 min) and the postoperative mean hospital stay was 3.3 days (range, 1e9 days). The mortality rate was restricted to zero. There were no major postoperative complications, except for 1 patient with respiratory failure, 3 patients with anastomotic leak or stricture and 3 patients with focal infection of the incisional wound (Table 3). 3.3. Follow-up Mean follow-up period, in a subtotal of 128 patients, was 10 months. As far as the effectiveness of the bariatric operations is concerned, data was reported only for 85 patients, who exhibited 44% weight loss on average. 4. Discussion This systematic review summarizes the available data regarding SILS-RYGB in bariatric patients. Six of the available studies identified were prospective cohort of relatively low quality. The rest of the included studies were either case reports or case series. In 2009, Saber et al. reported the first successful single port transumbilical laparoscopic RYGB in a 38-year-old female with BMI of 38.7 kg/m2 [9]. No major complications were reported and the patient was discharged from the hospital the first postoperative day. In the 3-month postoperative follow-up period, 18% reduction of the body weight was shown. The following year, Saber et al. published a series of 16 patients who had undergone laparoscopic RYGB through 3 incisions (transumbilical, right upper quadrant, subxiphoid) [17]. Surgical complications were limited to two patients (one with wound infection and one with atrial fibrillation). At the same year, Tacchino et al. published the first prospective cohort study regarding SILS-RYGB using a single port procedure (only one transumbilical incision) in 14 patients [18]. Tacchino et al. reported a 28% reduction of body weight and one patient with obstructive jaundice after a 12-month period. With regard to the access route used in the eligible studies, the transumbilical one was reported in all cases. However, as mentioned above, additional abdominal incisions were also reported in eight studies [5,7,12,14e17,19]. Specifically, a subxiphoid incision was required in 22.5% of the overall patients (n ¼ 191), a left upper quadrant (LUQ) in 12%, a right upper quadrant (RUQ) in 8%, a left lateral abdominal in 52%, an epigastric in 1 patient, while additional incisions are reported in 5 more patients without any
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Fig. 1. PRISMA flow diagram of transumbilical gastric bypass Search term: (single incision OR single port access OR SILS OR SITU) AND gastric bypass.
further details. These differentiations of the incision site are rational, since a solely single incision with the use of multi-access port devices can eliminate the need for additional scars, but it can predispose at the same time to incisional hernias [20]. On the other hand, making one or two extra incisions apart from the main umbilical one, may not require special devices and instruments and it presents less potential for the development of postoperative hernias [21]. It should also be pointed out that somatometric characteristics such as BMI and the distance between the umbilicus and the epigastric area, have to be taken into consideration in order to provide an individualized approach to each patient [12]. The surgical technique per se, did not vary at a great degree within the studies (eg. gastric pouch left, distance from Treitz ligament for anastomosis etc). The only remarkable difference among the studies included in this analysis is the fact that Lee et al. used a stapler to make the enterotomy closure after the jejunojenunal
anastomosis [14], Rogula et al. used and Endo Stitch [5], while the rest surgeons made it hand-sewn. Mean operative time was 128.5 min on average, ranging from 60 min [16] to 240 min [16]. Moreover, surgeons who used only transumbilical access did not seem to exhibit longer operative time than the overall average (134 min, vs 128.5 min, respectively). With regards to major operative complications, Lee et al. reported a 2% anastomotic leak rate and 3 patients required reoperation [14]. Tacchino et al. reported mild pneumonia with pleural effusion and non-obstructive jaundice, which resolved in one week, in one patient [18]. It should be highlighted that no death was reported. Wound complications such as seroma, infection and hernia are frequently seen following SILS [22]. Nonetheless, in SILS-RYGB wound infection was reported only in three cases, while no hernia on the incisional site was mentioned. These outcomes seem
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Table 1 Characteristics of eligible studies and demographic data of the patients. ASA status: American Society of Anesthesiologists Classification System, BMI: Body Mass Index, NOS: NewcastleeOttawa Quality Assessment Scale for cohort studies. Trial ID
Saber 2009 [9] Tacchino 2010 [18] Fernandez 2013 [12] Morales Conde 2013 [7] Marchesini 2013 [15] Huang 2012 [13] Saber 2010 [17] Lee 2012 [14] Pitot 2014 [16] Rogula 2014 [5] Total
Stars in Patients, Mean age ± SD Female, Ottawa n (years) n (%)
Journal
Surg Innov e Obes Surg 4 Obes Surg e Surg Endosc 4 ABCD e Surg Obes Relat Dis 5 Int J Surg e Surg Obes Relat Dis 7 Surg Endosc 7 Obes Surg 10
1 16 3 22 1 40 16 100 34 14 247
34 38.4 34 41 ± 9 50 30.6 ± 7.75 47 34 42.6 48.1 ± 11.3 37.3
1 (100) 16 (100) 3 (100) 21 (95) 1 (100) 36 (90) 12 (75) 70 (70) 24 (70) 12 (86%) 196 (79.4)
Mean preoperative ASA status, n (%) BMI ± SD (kg/m2) 1 2
3
4
38.7 43.5 37.2 42.7 ± 2.3 41 41.1 ± 5.1 42.4 43.2 41.9 40.2 ± 4.6 42.4
1 (100) 14 (87.5) 0 0 0 e 8 (50) e e 6 (43) 29 (40)
0 0 0 e 0 e 22 (100) e 0 1 e e 0 11 e e e e 0 e 22 (30) 12 (66.7)
0 0 1 (33) 0 1 (100) e 4 (25) e e 2 (14) 8 (10.9)
0 2 (12.5) 2 (67) 0 0 e 4 (25) e e 6 (43) 14 (19.5)
Prior abdominal operations
Table 2 Characteristics of the surgical procedure. Trial ID
Access route
Saber 2009 [9] Tacchino 2013 [18] Fernandez 2013 [12] Morales Conde 2013 [7] Marchesini 2013 [15] Huang 2012 [13] Saber 2010 [17]
Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical Transumbilical
Lee 2012 [14]
Transumbilical & left lateral abdominal wall Transumbilical Transumbilical
Pitot 2014 [16] Rogula 2014 [5] Total
Number of trocars used
& subxiphoid & & & &
2 1 3 (87%), 2 (13%) e LUQ incision 4 1 LUQ & subxiphoid 3 2 (86%) LUQ & epigastric 5 2 3 0 RUQ & subxiphoid & 4 2
25 22 30 22 27 29 22
1 16 3 22 1 40 16
(100) (100) (100) (100) (100) (100) (100)
1 2 3 22 1 40 16
(100) (12.5) (100) (100) (100) (100) (100)
3
1
22
100 (100)
100 (100)
2 3
4 (3%) 1 (14%)
10 22
34 (100) 14 (100) 247 (100)
34 (100) 14 (100) 233 (94.3)
much more encouraging than other published data [22]. The effectiveness of SILS-RYGB, in terms of weight loss, was specified in 85 patients. In these cases, a 41% mean weight loss was reported and the mean follow-up time after surgery was 10 months. These results are comparable with those of conventional laparoscopic gastric bypass, however there is a need of studies with a longer follow-up in order to draw more definite conclusions regarding the efficacy of SILS-RYGB [23,24]. At this point, it should be highlighted that SILS-RYGB has a significant learning curve. The surgeon needs to acquire high yield skills and expertise in laparoscopy in order to be able to accomplish such operations. The surgical procedure is much more demanding than the conventional one, since more careful and delicate maneuvers have to be made. While there is no available data regarding the experience of an average surgeon and the efficacy of SILS-RYGB in comparison with
Table 3 Preoperative comorbidities and postoperative complications of patients following single-incision laparoscopic Roux-en-Y gastric bypass surgery. GERD: Gastroesophageal Reflux Disease. Comorbidities
n, (%)
Complications
n, (%)
Arthritis Diabetes mellitus Dyslipidemia Hypertension GERD Sleep apnea syndrome Stress incontinence
24 25 32 26 10 13 5
Anastomotic leak/stricture Bleeding Conversion to open Hernia (incisional/internal) Renal failure Respiratory failure Wound infection
3 (1.2) 0 0 0 0 1 (0.4) 3 (1.2)
(15.6) (16.2) (22.8) (16.8) (6.4) (8.3) (3.2)
Additional Total mm of Surgical technique number transumbilical Gastrojejunal Jejunojenunal Enterotomy closure of incisions trocars anastomosis, anastomosis, (after JJ anastomosis), n (%) n (%) n (technique) 1 (handsewn) 16 (handsewn) 3 (handsewn) 22 (handsewn) 1 (handsewn) 40 (handsewn) 16 (handsewn intracorporeal) 100 (stapler) 34 (stapler) 14 (Endo Stitch)
conventional RYGB, Rogula et al. reported that the former is feasible in selected bariatric patients and that the short term outcomes are comparable between the two groups [5]. Finally, it should be noted that the majority of the patients (79.4%) were women. Many factors (such as having children, been teased for appearance, etc) have been found to be positively related to an interest in cosmetic surgery in females [25]. This may pose a limitation for the generalizability of the findings to the male population. The enhanced aesthetic results of SILS should be taken into consideration as an ameliorating psychological factor for the patient, especially for females. This study has several limitations that should be taken into account before the interpretation of our findings. The eligible studies include the initial experience of surgeons with this relatively new procedure and probably consist of data from selected patients, which makes our results not generalizable to the population overall. The small sample size e and the even smaller number of true SITU operations (104 patients in total) - and the short followup period of the eligible studies are another concern. Moreover, it is precarious to draw certain conclusions regarding the success of the procedures performed, since there is available data on weight loss for only 34% of patients. The heterogeneity among the studies in terms of differences in the surgical technique among surgeons (i.e. number of incisions, access site, different access devices, instruments and overall equipment) is another drawback of this study. On the other hand, the strengths of this study are the systematic approach adopted for the identification of the eligible studies, the detailed data extraction of all included studies, the rating of the
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quality of the studies, and the detailed reporting of extracted data. However, it should not be neglected that these reports come from highly skilled surgeons and may not be reproducible by average surgeons.
[2]
5. Conclusion
[4]
It has been demonstrated that SILS-RYGB is a feasible procedure with improved cosmetic results, when compared to conventional techniques. However, the high complication rate casts doubt on the efficacy and safety of this procedure. It is rational that in an attempt to achieve a “reduced port” technique, the clinical outcomes are being endangered at a certain degree. It is yet to be answered whether the risk for a better cosmetic result is acceptable or not by both the health professionals and the overall population. Randomized trials and larger cohort studies with longer follow-up are of paramount importance so as to evaluate and define the role of SILS-RYGB for the bariatric patient. Ethical approval None. Sources of funding None. Author contribution IPD contributed to the literature review, submitted, and drafted the paper. KPE contributed to study conception, design, edited the paper and is guarantor for the manuscript. All authors read and approved the final manuscript.
[3]
[5]
[6]
[7]
[8] [9]
[10]
[11] [12]
[13]
[14]
[15]
[16]
[17]
Conflict of interest None.
[18] [19]
Guarantor [20]
Konstantinos P Economopoulos. [21]
Acknowledgments [22]
None. Appendix A. Supplementary data
[23]
Supplementary data related to this article can be found at http:// dx.doi.org/10.1016/j.ijsu.2015.06.077.
[24]
References
[25]
[1] C. Ricci, M. Gaeta, E. Rausa, Y. Macchitella, L. Bonavina, Early impact of bariatric surgery on type II diabetes, hypertension, and hyperlipidemia: a
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