Top

Published in:

01-08-2013 | Controlled Clinical Trial

Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)—a randomized controlled trial

Authors: Serin Schiessling, Christine Leowardi, Peter Kienle, Dalibor Antolovic, Phillip Knebel, Thomas Bruckner, Martina Kadmon, Christoph M. Seiler, Markus W. Büchler, Markus K. Diener, Alexis Ulrich

Published in: Langenbeck's Archives of Surgery | Issue 6/2013

Abstract

Purpose

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the standard surgical procedure for ulcerative colitis (UC) and familial adenomatous polyposis (FAP). While minimal invasive techniques have been applied increasingly, clear evidence of superiority for laparoscopic pouch procedures is not yet available. The aim of the LapConPouch Trial was to compare the effectiveness of laparoscopic (LAP) versus conventional (CON) ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy.

Methods

The trial was designed as a single-centre, pre-operatively randomized, controlled trial using a two-group parallel superiority design. Eligible for participation were patients scheduled for restorative proctocolectomy either for FAP or for UC. Patients and outcome assessors were blinded to group assignment. The primary endpoint was defined as the amount of blood loss. Statistical analyses were explorative since the trial had to be stopped prematurely.

Results

A total of 42 patients (21 LAP (50.0 %); 21 CON (50.0 %)) were randomized. The trial had to be stopped prematurely due to insufficient patient recruitment. There was no difference in the amount of blood loss between both groups: LAP 261.5 ± 195.4 ml, CON 228.1 ± 119.5 ml. Secondary endpoints differ in both groups. Laparoscopic surgery was superior regarding the length of skin incision; in contrast, the conventional approach was superior in duration of operation. There were no discrepancies in length of hospital stay, postoperative pain, bowel function, and quality of life between both approaches. The conversion rate from LAP to CON approach was 23.8 %.

Conclusion

There was no difference with respect to blood loss between the LAP and the CON group. The LAP approach is feasible for restorative proctocolectomy, and IPAA seems at least as safe as CON surgery. The most obvious advantage of the minimal invasive technique is the improved cosmesis.

Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G, Clinical Outcomes of Surgical Therapy (COST) Study Group (2002) Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA 287(3):321–328PubMedCrossRef

Sardinha TC, Wexner SD (1998) Laparoscopy for inflammatory bowel disease: pros and cons. World J Surg 22(4):370–374PubMedCrossRef

Marcello PW, Milsom JW, Wong SK, Hammerhofer KA, Goormastic M, Church JM et al (2000) Laparoscopic restorative proctocolectomy: case-matched comparative study with open restorative proctocolectomy. Dis Colon Rectum 43(5):604–608PubMedCrossRef

Maartense S, Dunker MS, Slors JF, Cuesta MA, Gouma DJ, van Deventer SJ et al (2004) Hand-assisted laparoscopic versus open restorative proctocolectomy with ileal pouch anal anastomosis: a randomized trial. Ann Surg 240(6):984–991, discussion 991–2PubMedCrossRef

Fleming FJ, Francone TD, Kim MJ, Gunzler D, Messing S, Monson JR (2011) A laparoscopic approach does reduce short-term complications in patients undergoing ileal pouch-anal anastomosis. Dis Colon Rectum 54(2):176–182PubMedCrossRef

Fajardo AD, Dharmarajan S, George V, Hunt SR, Birnbaum EH, Fleshman JW et al (2010) Laparoscopic versus open 2-stage ileal pouch: laparoscopic approach allows for faster restoration of intestinal continuity. J Am Coll Surg 211(3):377–383PubMedCrossRef

Sammour T, Kahokehr A, Srinivasa S, Bissett IP, Hill AG (2011) Laparoscopic colorectal surgery is associated with a higher intraoperative complication rate than open surgery. Ann Surg 253(1):35–43, ReviewPubMedCrossRef

Antolovic D, Kienle P, Knaebel HP, Schmidt J, Gutt CN, Weitz J et al (2006) Totally laparoscopic versus conventional ileoanal pouch procedure—design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy—LapConPouch-trial. BMC Surg 6:13PubMedCrossRef

Kienle P, Z'graggen K, Schmidt J, Benner A, Weitz J, Büchler MW (2005) Laparoscopic restorative proctocolectomy. Br J Surg 92(1):88–93PubMedCrossRef

10.

Ware JE, Kosinski M, Keller SD (1994) SF-36 Physical and Mental Health Summary Scales: a user's manual. The Health Institute, New England Medical Center, Boston

11.

Dunker MS, Bemelman WA, Slors JF, van Duijvendijk P, Gouma DJ (2001) Functional outcome, quality of life, body image, and cosmesis in patients after laparoscopic-assisted and conventional restorative proctocolectomy: a comparative study. Dis Colon Rectum 44(12):1800–1807PubMedCrossRef

12.

Food and Drug Administration, Department of Health and human Services. International Conference on Harmonization (1998) Guidance on statistical principles for clinical trials, availability. Fed Regist 63(179) http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129505.pdf

13.

Psaty BM, Rennie D (2003) Stopping medical research to save money: a broken pact with researchers and patients. JAMA 289(16):2128–2131PubMedCrossRef

14.

Schroen AT, Petroni GR, Wang H, Gray R, Wang XF, Cronin W et al (2010) Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Clin Trials 7(4):312–321, Epub 2010Jul 1PubMedCrossRef

15.

Taylor KM, Feldstein ML, Skeel RT, Pandya KJ, Ng P, Carbone PP (1994) Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1,737 Eastern Cooperative Oncology Group investigators. J Clin Oncol 12(9):1796–1805PubMed

16.

Ahmed Ali U, Keus F, Heikens JT, Bemelman WA, Berdah SV, Gooszen HG et al (2009) Open versus laparoscopic (assisted) ileo pouch anal anastomosis for ulcerative colitis and familial adenomatous polyposis. Cochrane Database Syst Rev Jan 21(1):CD006267 Review doi:10.1002/14651858.CD006267.pub2

17.

Wu XJ, He XS, Zhou XY, Ke J, Lan P (2010) The role of laparoscopic surgery for ulcerative colitis: systematic review with meta-analysis. Int J Colorectal Dis 25(8):949PubMedCrossRef

18.

Tilney HS, Lovegrove RE, Heriot AG, Purkayastha S, Constantinides V, Nicholls RJ et al (2007) Comparison of short-term outcomes of laparoscopic vs open approaches to ileal pouch surgery. Int J Colorectal Dis 22(5):531–542, Epub 2006 Aug 10, reviewPubMedCrossRef

19.

Araki Y, Isomoto H, Tsuzi Y, Matsumoto A, Yasunaga M, Toh U et al (1998) Clinical aspects of total colectomy—laparoscopic versus open technique for familial adenomatous polyposis and ulcerative colitis. Kurume Med J 45(2):203–207PubMedCrossRef

20.

Flores P, Bailez MM, Cuenca E, Fraire C (2010) Comparative analysis between laparoscopic (UCL) and open (UCO) technique for the treatment of ulcerative colitis in pediatric patients. Pediatr Surg Int 26(9):907–911, Epub 2010 Jul 15PubMedCrossRef

21.

Polle SW, Dunker MS, Slors JF, Sprangers MA, Cuesta MA, Gouma DJ et al (2007) Body image, cosmesis, quality of life, and functional outcome of hand-assisted laparoscopic versus open restorative proctocolectomy: long-term results of a randomized trial. Surg Endosc 21(8):1301–1307, Epub 2007 May 24PubMedCrossRef

22.

Larson DW, Davies MM, Dozois EJ, Cima RR, Piotrowicz K, Anderson K et al (2008) Sexual function, body image, and quality of life after laparoscopic and open ileal pouch-anal anastomosis. Dis Colon Rectum 51(4):392–396, Epub 2008 Jan 24PubMedCrossRef

23.

Franzoi SL, Koehler V (1998) Age and gender differences in body attitudes: a comparison of young and elderly adults. Int J Aging Hum Dev 47(1):1–10PubMedCrossRef

24.

Berdah SV, Mardion RB, Grimaud JC, Barthet M, Orsoni P, Moutardier V et al (2009) Mid-term functional outcome of laparoscopic restorative proctocolectomy: a prospective study of 40 consecutive cases. J Laparoendosc Adv Surg Tech A 19(4):485–488PubMedCrossRef

Title: Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)—a randomized controlled trial
Authors: Serin Schiessling
Christine Leowardi
Peter Kienle
Dalibor Antolovic
Phillip Knebel
Thomas Bruckner
Martina Kadmon
Christoph M. Seiler
Markus W. Büchler
Markus K. Diener
Alexis Ulrich
Publication date: 01-08-2013
Publisher: Springer Berlin Heidelberg
Published in: Langenbeck's Archives of Surgery / Issue 6/2013
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI: https://doi.org/10.1007/s00423-013-1088-z

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Laparoscopic versus conventional ileoanal pouch procedure in patients undergoing elective restorative proctocolectomy (LapConPouch Trial)—a randomized controlled trial

Abstract

Purpose

Methods

Results

Conclusion

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 6/2013

Surgical treatment of acute pancreatitis

Outcome after surgery for primary hyperaldosteronism may depend on KCNJ5 tumor mutation status: a population-based study from Western Norway

Blood transfusion does not adversely affect survival after elective colon cancer resection: a propensity score analysis

Scoring of human acute pancreatitis: state of the art

Procalcitonin as a predictive marker for surgical site infection in elective colorectal cancer surgery

Comparative analysis of the revenues of pylorus-preserving pancreatic head resections and laparoscopic cholecystectomies as prototypic surgical procedures in the German health-care system