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

This 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.The 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.Trial registration : ISCRTN61411448There is little comparative data on restorative proctocolectomy performed via conventional or minimal invasive surgical approaches. The technical feasibility of the laparoscopic approach for performing restorative proctocolectomy has been shown in several series in specialized centres [1-4]. However, there is controversy in the literature on the actual benefit of minimal invasive techniques for extensive colorectal procedures. Numerous smaller randomised and case controlled studies in different fields of colorectal surgery have shown distinct advantages for laparoscopic compared to open procedures in the early postoperative phase [5-8], but the large randomized COST-study on colorectal cancer procedures could only find marginal short term quality of life benefits in the minimally invasively treated group [9]. The majorit