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.

Dalibor Antolovic,Peter Kienle,Markus W Büchler,Jan Schmidt,Hanns-Peter Knaebel,Carsten N Gutt,Moritz Koch,Christoph M Seiler,Jürgen Weitz

doi:10.1186/1471-2482-6-13

Dalibor Antolovic, Peter Kienle + Show 7 more

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https://doi.org/10.1186/1471-2482-6-13

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Journal: BMC Surgery	Publication Date: Nov 24, 2006
Citations: 28	License type: cc-by

Affiliation: Heidelberg University

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BackgroundRestorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study.Methods/designThis is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life.DiscussionThe trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach.

Highlights

Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study
Trial population LapCon-Pouch includes patients over 18 years of age who are planned for an elective restorative proctocolectomy with an ileoanal pouch and are eligible for both surgical approaches, i.e. conventional or totally laparoscopic
We hypothesise that intraoperative blood loss and the need for perioperative blood transfusions are significantly higher in the conventional group

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Introduction

Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study. One smaller case-matched study documented superiority for the laparoscopically assisted group in terms of faster return of intestinal function and shorter hospital stay [1]. Another recently published case matched study found no significant differences in regard to complications and an equivalent quality of life after one year [13]. This is in accord with the only randomized trial comparing hand-assisted laparoscopic to open restorative proctocolectomy [14]. Morbidity was similar in both groups and quality of life in the first three months was equivalent questioning the postulated advantage of the minimal invasive approach in regard to early postoperative recovery

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