Robotic single docking total colectomy for ulcerative colitis: First experience with a novel technique

Robotic single docking total colectomy for ulcerative colitis: First experience with a novel technique

International Journal of Surgery 21 (2015) 63e67 Contents lists available at ScienceDirect International Journal of Surgery journal homepage: www.jo...

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International Journal of Surgery 21 (2015) 63e67

Contents lists available at ScienceDirect

International Journal of Surgery journal homepage: www.journal-surgery.net

Original research

Robotic single docking total colectomy for ulcerative colitis: First experience with a novel technique Franco Roviello a, *, Riccardo Piagnerelli a, Francesco Ferrara b, Maximilian Scheiterle b, Lorenzo De Franco b, Daniele Marrelli b a b

Department of Medicine, Surgery and Neuroscience, Unit of Minimally Invasive Surgery, University of Siena, Italy Department of Medicine, Surgery and Neuroscience, Unit of Surgical Oncology, University of Siena, Italy

h i g h l i g h t s  We present a novel approach for robotic total colectomy.  This is the first series in literature.  This technique allows to perform a time saving procedure.

a r t i c l e i n f o

a b s t r a c t

Article history: Received 13 June 2015 Received in revised form 11 July 2015 Accepted 19 July 2015 Available online 21 July 2015

Introduction: We describe a novel technique that could aid the surgeon to perform a total proctocolectomy with a single docking position of the da Vinci Si HD System. Methods: Patients were positioned in 20 Trendelenburg lithotomy split legs position. A 12-mm trocar was for camera and 3 more trocars were placed: two robotics on left and right flanks and one laparoscopic in left iliac fossa. The robot was docked between the legs of the patients. Results: Four proctocolectomies were performed. Mean operative time was 235 min (range 215e255); mean blood loss was 100 cc (range 50e200). Median post-operative stay was 6 days. Overall morbidity was 75%, whereas major complications occurred in 25%. Post-operative mortality was null. Conclusions: The robotic single docking approach to perform total proctocolectomy for ulcerative colitis is a time-saving technique respect to the multiple docking approach. © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Keywords: Robotic surgery Total proctocolectomy Ulcerative colitis Colorectal surgery

1. Introduction Ulcerative colitis (UC) is a benign disease characterized by a chronic relapsing and remitting inflammation of the colon-rectum. Medical treatment, including corticosteroids, antibiotics, immunomodulators, 5-aminosalicylate and biological agents, is the first line approach. Because of steroid-dependence, therapy refractory disease, unacceptable medical side-effects, suspect of malignant degeneration and non-compliant behavior, up to 35% of patients need surgical treatment [1,2]. A total (procto)colectomy is often required and this procedure is defined as standard in the last European Crohn's and Colitis Organization (ECCO) and American Society of Colon and Rectal Surgeons (ASCRS) guidelines [3,4]. Total

* Corresponding author. Azienda Ospedaliera Universitaria Senese, Viale Bracci, 14 e 53100 Siena, Italy. E-mail address: [email protected] (F. Roviello).

proctocolectomy can be performed by open or minimally-invasive approach. The surgical technique does not require an oncological resection, such as mesenteric excision, radical lymphadenectomy and ligation of the vessels near their origin. This allows a close to the bowel dissection and it can be performed as a one-, two- or three-stage procedure. In the first case after colectomy, ileal-pouch anal anastomosis (IPAA) is performed. In the second approach, the IPAA is protected by a temporary diverting ileostomy. In the latter, colectomy with terminal ileostomy is performed, then the IPAA is carried out with diverting ileostomy and, finally, the intestinal transit is restored [5,6]. Nowadays the minimally-invasive approach, like conventional laparoscopy or robotic surgery, can offer these patients better cosmesis, less post-operative pain and fewer complications, minimizing the trauma of surgery [7]. The robotic technique has been introduced to overtake the limitations of laparoscopy, especially in terms of dexterity, visualization and shorter learning curve [8]. In effect, robotics has the potential to

http://dx.doi.org/10.1016/j.ijsu.2015.07.642 1743-9191/© 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

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provide an enhanced and clear view even within a narrow pelvis, with improved visualization of the nerves and their branches and a better manipulation in a field difficult to access in laparoscopy [9]. Moreover the learning curve of the robotic technique seems to be faster than laparoscopic surgery, probably because robotic assistance improves performance with complex tasks, while decreasing operator workload [10]. Finally, several reports have demonstrated the non inferiority of robotics compared to laparoscopy, in terms of short and long-term outcomes [11]. Despite these advantages, this approach is burdened by some drawbacks, such as higher costs and increased operative time respect to conventional laparoscopy [9,12]. In procedures like total colectomy, one of the reasons of this limitation is certainly due to the presence of large operative fields (i.e. the entire abdominal cavity), which often require an intraoperative redocking of the robotic cart in order to achieve the best position for every step of the surgical procedure. In addition the surgical table needs to be tilted during the cart redocking, with a relevant waste of time. Consequently time consumption is one of the main limitations of robotic approach, minimizing its advantages [13]. For the purposes of this study, we hypothesized we could perform a robotic single docking total proctocolectomy to overcome the principal limitation of this type of minimally invasive approach, preserving all its advantages. In this technical note we present our first experience using the da Vinci Si HD™ Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA). To our knowledge this is the first report in literature to describe this type of approach. 2. Materials & methods Four patients were affected by UC not responsive to medical treatment, based on immunosuppressive drugs and high dose corticoids. The common colonoscopy finding was severe inflammatory state involving the whole colonic mucosa with rectal sparring. Blood tests revealed mild anemia in each case, with high levels of inflammatory markers, such as CRP, fibrinogen, neutrophilic leukocytosis. The operative time was measured from the first incision to skin closure. Post-operative morbidities were classified according to Clavien-Dindo classification. Major morbidities were defined as Clavien-Dindo grade III-IV complications. The recovery of bowel function was recorded through the ileostomy. 2.1. Preparation to surgery Surgery was elective for all patients. They were prepared for the surgical operation administering antibiotic prophylaxis based on Cefotaxime 1 g and Metronidazole 500 mg, steroids and proton pump inhibitors before the induction. Deep venous thrombosis prophylaxis with low molecular weight heparin was also administered 12 h before the procedure. 2.2. Surgical procedure In all cases a close-to-the-bowel dissection was performed, because no evidence of cancer has been found pre- and intraoperatively. After the induction of anesthesia patients were positioned in 20 Trendelenburg lithotomy position, with arms along the body tucked in sterile drapes and split legs. Pneumoperitoneum was induced and maintained at 8 mmHg using Verres needle technique on Palmer's point. A 12-mm trocar was placed in the epigastrium and a 3D HD camera inserted. Three more trocars were inserted: two 8-mm robotics, one on the left and one on the right flank; one 12-mm laparoscopic, on the left iliac fossa, for the

Fig. 1. Port placement (R1: robotic arm 1; R2: robotic arm 2; L1: assistant port).

assistant (Fig. 1). The robotic system was docked caudally, between the patient's legs. The first robotic arm (R1) was equipped with monopolar scissors and the second one (R2) with bipolar Cadiere forceps. The assistant surgeon stent on the left of the patient (Fig. 2) and started to retract medially the right colon. The terminal ileum, caecum and ascending colon were dissected with a lateral-tomedial approach and the ileo-colic vessels were individuated, ligated with Hem-O-lok™ clips, XL size, (Teleflex Medical Inc. Research Triangle Park, NC) and dissected. Then the terminal ileum was interrupted 10 cm from the ileo-caecal valve, with an Endo GIA™ Purple Reload with Tri-Staple™ Technology (Covidien™, Mansfield, MA), introduced through the assistant port. While the assistant applied gentle traction on ascending colon towards the left iliac spine, the hepatic flexure was mobilized and taken down. The gastro-colic ligament was opened rising up and retracting the transverse colon towards the pelvis. Then the transverse mesocolon was exposed. A small gauze was inserted behind the transverse mesocolon from the middle colic vessels to the splenic flexure. The right and middle colic vessels were dissected between Hem-O-lok clips and the transverse mesocolon divided. The splenic flexure was approached lateral-to-medially. The left colon was mobilized in a cranio-caudally way. A small gauze was placed onto the Gerota's fascia. The inferior mesenteric vessels were dissected between Hem-O-lok clips. The sigmoid colon and superior rectal vessels were isolated. The rectum was finally dissected under the peritoneal reflection, first approaching the “holy plane”, later the Denonvillier's fascia (on male patients) and finally the mesorectal lateral aspects until the perineal plane. This dissection was achieved pulling gently the sigmoid colon cranially by the assistant. The distal transection was performed using an Endo GIA™ Radial Reload with Tri-Staple™ Technology (Covidien™, Mansfield, MA), introduced through the assistant port. Finally the robotic system was undocked. A right flank incision was performed in order to extract the specimen and to carry out a temporary terminal ileostomy. Pneumoperitoneum was then reinduced in order to control hemostasis and place a drainage in pelvis.

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Fig. 2. Operation room setup.

3. Results From June to December 2014 4 patients underwent to robotic single docking total proctocolectomy for UC in our Unit of Minimally Invasive Surgery, Department of Medicine, Surgery and Neuroscience, University of Siena, Italy. Demographic data and post-operative outcomes of the patients included in the study are reported in Table 1. All the patients were classified as ASA risk II. None of them has previously undergone to any abdominal surgical procedure. The operations were 4 proctocolectomies with terminal ileostomy. No conversions to open or laparoscopic surgery were registered for all the procedures. No need of intraoperative blood transfusion was reported. Post-operative complications occurred in 3 patients. Two patients presented minor complications. In one case a wound infection was treated with antibiotic therapy. Another

Table 1 Demographic data and operative outcomes of the patients. Median age, years Male:Female ratio Median BMI, kg/m2 Pre-operative diagnosis Procedures Mean operative time, minutes Mean blood loss, mL Median recovery of bowel function, days Median post-operative stay, days Overall morbidity Major morbidity Post-operative mortality

30 (range 24e35) 2:2 22 (range 18e26) 4 UC 4 proctocolectomies 235 (range 215e255) 100 (range 50e200) 3 6 75% 25% 0

patient suffered from acute pulmonary edema underwent to with medical treatment. In one case a major complication was reported, a small bowel obstruction due to an internal hernia, requiring surgical reoperation, with no need of any bowel resection and resolution of the intestinal occlusion. The reoperation was performed in laparoscopy. No abdominal collections or other complications were detected. The post-operative mortality was null. The pathological examination of the specimens revealed absence of malignant lesions in all cases. 4. Discussion Since 2001, when the first report described the application of the robotic system for the treatment of benign colorectal diseases [14], several authors have reported their experiences on robotic colorectal surgery [15,16]. In elective surgery UC patients are considered ideal candidates for advanced minimally invasive surgery. The benefits of earlier post-operative recovery, better cosmetic results, possible long-term advantages in terms of facilitated re-operation and fertility in females are considered important outcome parameters in this patients that are often young [17]. In acute setting robotic colectomy is certainly unsuitable as it is considered both unsafe and unwise to proceed with pelvic resection in acute scenario. There are different assessed advantages of the robotic system over the traditional laparoscopic approach, like a stable and magnified 3D HD view or the possibility of using various and multi-articulated endoscopic instruments (Endowrist® System). These features allow the surgeon to better identify anatomic structures and increase the freedom of movements inside the abdominal cavity [18]. This is particularly true in some surgical

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procedures that require a special dexterity of the laparoscopic surgeon, such as total colectomies. Different studies on the use of robotics in colorectal surgery seemed to be promising, but pointed out the difficulty to approach multiple quadrants of the abdomen with the robotic system. The problems identified included a limited range of motion, narrow surgical fields and, mainly, the need to reposition the robotic cart several times during the same procedure [19]. This is one of the main reasons of time consumption during a robotic procedure. We introduced single-docking approach to avoid the necessity of redocking the robotic system several times during the same procedure characterized by the manipulation in all abdominal quadrants. To our knowledge this is the first experience reported in literature and it seems to be safe and feasible when performed by a surgeon familiar with the robotic system. Actually we have performed our first 4 total proctocolectomies, that can be performed as one-, two- or three-stage procedures in elective surgery [5]. We preferred to delay the time of the IPAA [17] to avoid the risk of post-operative anastomotic leakage, that, in these patients ranges from 7 to 20%, higher than other colorectal procedures [20,21]. This may occur during immunosuppressive and high dose corticoid medication, which could significantly increase the risk of anastomosis-related complications [6,22]. In our first experience we decided to start with a three-stage approach, first performing a total proctocolectomy with terminal ileostomy. Then we planned a second stage laparoscopic procedure to carry out the IPAA by one year from the first operation; the terminal ileostomy has to be released in the beginning and a diversion loop ileostomy created at the same site at the end of the procedure. After one month, if the IPAA did not present any complication, the final ileostomy-closure has to be performed. Actually two patients underwent to all the three-stage procedures, without complications. For this our first experience we chose this cautious approach, to prevent eventual anastomosis-related complications. Furthermore, even if an additional surgical procedure is needed, the presence of a terminal or diverting ileostomy does not change considerably the quality of life. In order to obtain better outcomes in this field, several authors have proposed different approaches in colorectal surgery. Actually there is a growing interest for single-port procedures and many authors have proposed this type of approach even in robotic surgery. Juo and Obias [23] proposed a single-port approach to perform a robotassisted total colectomy for familial adenomatous polyposis (FAP). The procedure was described as safe and feasible with the advantages of better cosmesis and less trauma to the abdominal wall. However they confirmed its technical difficulty together with the necessity of undocking and redocking the robotic cart several times. This was the major additional disadvantage they have identified with the procedure. We are also evaluating the possibility to perform the second-stage procedure with single-port technique, using the ileostomy site as an access route, as already described [24]. Other authors have described the single-docking approach for other procedures that routinely require a multiple-docking approach, such as rectal resection. In fact in this procedure the robotic cart needs to be docked two times, one for the splenic flexure mobilization and the other for the total mesorectal resection. Several surgeons have tried different techniques to overcome the challenge of performing a low anterior resection with total mesorectal excision and splenic flexure mobilization using the da Vinci robotic system [18,19,25]. Obias et al. [26] adopted the ‘flip arm’ technique, which utilizes all three robotic arms throughout the procedure and keeps the patient-side cart docked only once. This technique overcomes the need to reposition the robot for the mobilization of the splenic flexure and this will account in an overall reduction of operative time. Only few authors have described a robotic approach to inflammatory bowel disease. Pedraza et al. [27] reported five cases of restorative

proctocolectomy with IPAA for UC with a robotic multiple docking technique. The operative time was 333 min, longer than ours, but we cannot say if it was related to the redocking time or to the IPAA, that in our experience was not performed. Obviously the multiple docking is a time consuming procedure that prolongs even further the overall operative time. Compared to laparoscopy, our operative time of 235 min was similar and, in some cases, inferior to other reported experiences, even if not all the procedures were the same [5,28e31]. In general our experience demonstrates the possibility to get access to the entire width of the abdominal cavity, through a single docking position of the robotic cart, and this is the first mention of this approach in the literature. 5. Conclusion In conclusion our first experience using a robotic single docking technique for total proctocolectomy for UC shows that this procedure is safe and feasible when performed by robotic experienced surgical team. This approach could be employed in non responsive UC and in other diseases, like FAP, with no evidence of malignant transformation. The robotic single docking approach could be a time-saving technique respect to the multiple docking approach. Future studies would be necessary to demonstrate the supposed clinical advantages of the robot-assisted single-docking approach in comparison with the conventional multiple docking or laparoscopy or with other types of approach. Conflict of interest statement All the authors have no conflicts of interest or financial ties to disclose. Author contribution Franco Roviello: design of the study and critical revision. Riccardo Piagnerelli: writing of the paper and critical revision. Francesco Ferrara, Maximilian Scheiterle, Lorenzo De Franco: writing of the paper and data research. Daniele Marrelli: critical revision. Funding None. Ethical approval None. Guarantors Franco Roviello and Daniele Marrelli. Research registration researchregistry306. References [1] J. Filippi, P.B. Allen, X. Hebuterne, L. Peyrin-Biroulet, Does anti-TNF therapy reduce the requirement for surgery in ulcerative colitis? a systematic review, Curr. Drug Targets 12 (2011) 1440e1447. [2] L.E. Targownik, H. Singh, Z. Nugent, C.N. Bernstein, The epidemiology of colectomy in ulcerative colitis: results from a population-based cohort, Am. J. Gastroenterol. 107 (2012) 1228e1235. mann, T. Oresland, W.A. Bemelman, Y. Chowers, [3] S.P. Travis, E.F. Stange, M. Le J.F. Colombel, G. D'Haens, S. Ghosh, P. Marteau, W. Kruis, N.J. Mortensen, F. Penninckx, M. Gassull, European Crohn's and Colitis Organisation (ECCO),

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[4]

[5]

[6]

[7]

[8]

[9] [10]

[11] [12] [13]

[14]

[15]

[16]

European evidence-based consensus on the management of ulcerative colitis: current management, J. Crohns Colitis 2 (2008) 24e62. J.L. Cohen, S.A. Strong, N.H. Hyman, W.D. Buie, G.D. Dunn, C.Y. Ko, P.R. Fleshner, T.J. Stahl, D.G. Kim, A.L. Bastawrous, W.B. Perry, P.A. Cataldo, J.F. Rafferty, C.N. Ellis, J. Rakinic, S. Gregorcyk, P.C. Shellito, J.W. Kilkenny, C.A. Ternent, W. Koltun, J.J. Tjandra, C.P. Orsay, M.H. Whiteford, J.R. Penzer, Standards practice task force American society of colon and rectal surgeons, practical parameters for the surgical treatment of ulcerative colitis, Dis. Colon Rectum 48 (2005) 1997e2009. I. McAllister, P.M. Sagar, I. Brayshaw, S. Gonsalves, G.L. Williams, Laparoscopic restorative proctocolectomy with and without previous subtotal colectomy, Colorectal Dis. 11 (2009) 296e301. U.A. Heuschen, U. Hinz, E.H. Allemeyer, M. Lucas, G. Heuschen, C. Herfarth, One- or two-stage procedure for restorative proctocolectomy: rationale for a surgical strategy in ulcerative colitis, Ann. Surg. 234 (6) (2001) 788e794. M. Vitellaro, G. Bonfanti, P. Sala, E. Poiasina, M. Barisella, S. Signoroni, A. Mancini, L. Bertario, Laparoscopic colectomy and restorative proctocolectomy for familial adenomatous polyposis, Surg. Endosc. 25 (6) (2011) 1866e1875. A.H. Mirnezami, R. Mirnezami, A.K. Venkatasubramaniam, K. Chandrakumaran, T.D. Cecil, B.J. Moran, Robotic colorectal surgery: hype or new hope? a systematic review of robotics in colorectal surgery, Colorectal Dis. 12 (2010) 1084e1093. E.H. Aly, Robotic colorectal surgery: summary of the current evidence, Int. J. Colorectal Dis. 29 (1) (2014) 1e8. G. Melich, Y.K. Hong, J. Kim, H. Hur, S.H. Baik, N.K. Kim, A. Sender Liberman, B.S. Min, Simultaneous development of laparoscopy and robotics provides acceptable perioperative outcomes and shows robotics to have a faster learning curve and to be overall faster in rectal cancer surgery: analysis of novice MIS surgeon learning curves, Surg. Endosc. 29 (3) (2015) 558e568. N.C. Buchs, Robotic technology: optimizing the outcomes in rectal cancer? World J. Clin. Oncol. 6 (3) (2015) 22e24. A.K. Fung, E.H. Aly, Robotic colonic surgery: is it advisable to commence a new learning curve? Dis. Colon Rectum 56 (2013) 786e796. J.Y. Shin, Comparison of short-term surgical outcomes between a robotic colectomy and a laparoscopic colectomy during early experience, J. Korean Soc. Coloproctol. 28 (2012) 19e26. P.A. Weber, S. Merola, A. Wasielewski, G.H. Ballantyne, Telerobotic-assisted laparoscopic right and sigmoid colectomies for benign disease, Dis. Colon Rectum 45 (2002) 1689e1694. P.P. Bianchi, C. Ceriani, A. Locatelli, G. Spinoglio, M.G. Zampino, A. Sonzogni, C. Crosta, B. Andreoni, Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes, Surg. Endosc. 24 (2010) 2888e2894. A.L. Rawlings, J.H. Woodland, R.K. Vegunta, D.L. Crawford, Robotic versus laparoscopic colectomy, Surg. Endosc. 21 (2007) 1701e1708.

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[17] C.J. Buskens, S. Sahami, P.J. Tanis, W.A. Bemelman, The potential benefits and disadvantages of laparoscopic surgery for ulcerative colitis: a review of current evidence, Best Pract. Res. Clin. Gastroentrol. 28 (2014) 19e27. [18] J.R. Ramos, E. Parra-Davila, Four-arm single docking full robotic surgery for low rectal cancer: technique standardization, Rev. Col. Bras. Cir. 41 (2014) 216e223. [19] Y.A. Park, J.M. Kim, S.A. Kim, B.S. Min, N.K. Kim, S.K. Sohn, K.Y. Lee, Totally robotic surgery for rectal cancer: from splenic flexure to pelvic floor in one set-up, Surg. Endosc. 24 (2010) 715e720. [20] A.P. Meagher, R. Farouk, R.R. Dozois, K.A. Kelly, J.H. Pemberton, Ileal pouchanal anastomosis for chronic ulcerative colitis: complications and long-term outcome in 1310 patients, Br. J. Surg. 85 (1998) 800e803. [21] S. de Silva, C. Ma, M.C. Proulx, M. Crespin, B.S. Kaplan, J. Hubbard, et al., Postoperative complications and mortality following colectomy for ulcerative colitis, Clin. Gastroenterol. Hepatol. 9 (2011) 972e980. [22] C.R. Selvasekar, R.R. Cima, D.W. Larson, et al., Effect of infliximab on shortterm complications in patients undergoing operation for chronic ulcerative colitis, J. Am. Coll. Surg. 204 (2007) 956e962 (discussion 62e3). [23] Y.Y. Juo, V. Obias, Robot-assisted single-incision total colectomy: a case report, Int. J. Med. Robot. 11 (1) (2015) 104e108. [24] D.R. Bulian, J. Knuth, B. Krakamp, M.M. Heiss, Restorative rest proctectomy as single-port surgery through the ostomy site in a three-stage procedure, Surg. Endosc. 26 (12) (2012) 3688e3690. [25] M. Hellan, H. Stein, A. Pigazzi, Totally robotic low anterior resection with total mesorectal excision and splenic flexure mobilization, Surg. Endosc. 23 (2009) 447e451. [26] V. Obias, C. Sanchez, A. Nam, G. Montenegro, R. Makhoul, Totally robotic single-position 'flip' arm technique for splenic flexure mobilizations and low anterior resections, Int. J. Med. Robot. 7 (2) (2011) 123e126. [27] R. Pedraza, C.B. Patel, D.I. Ramos-Valadez, E.M. Haas, Robotic-assisted laparoscopic surgery for restorative proctocolectomy with ileal J pouch-anal anastomosis, Minim. Invasive Ther. Allied Technol. 20 (4) (2011) 234e239. [28] D.W. Larson, R.R. Cima, E.J. Dozois, M. Davies, K. Piotrowicz, S.A. Barnes, et al., Safety, feasibility, and short-term outcomes of laparoscopic ileal-pouch-anal anastomosis: a single institutional case-matched experience, Ann. Surg. 243 (2006) 667e670 (discussion 670e2). [29] P. Kienle, K. Z'Graggen, J. Schmidt, A. Benner, J. Weitz, M.W. Buchler, Laparoscopic restorative proctocolectomy, Br. J. Surg. 92 (2005) 88e93. [30] S. Maartense, M.S. Dunker, J.F. Slors, M.A. Cuesta, D.J. Gouma, S.J. van Deventer, et al., Hand-assisted laparoscopic versus open restorative proctocolectomy with ileal pouch anal anastomosis: a randomized trial, Ann. Surg. 240 (2004) 984e991. [31] M. Ouaissi, A. Alves, Y. Bouhnik, P. Valleur, Y. Panis, Three step ileal pouchanal anastomosis under total laparoscopic approach for acute or severe colitis complicating inflammatory bowel disease, J. Am. Coll. Surg. 202 (2006) 637e642.