Totally laparoscopic versus conventional ileoanal pouch procedure: A randomised controlled trial

Completed

• Conditions: Proctocolectomy; Digestive System; Familial polyposis or ulcerative colitis

• Registration Number: ISRCTN61411448
• Lead Sponsor: niversity of Heidelberg Medical School (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-24
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Hospitalised patients of the Department of General surgery, Visceral surgery, Trauma surgery and Outpatient Clinic of the University of Heidelberg, Medical School, who are planned for an elective restorative proctocolectomy either for familial polyposis or for ulcerative colitis. 160 patients (80 laparoscopic vs 80 conventional ileoanal pouch) will be enrolled in order to recruit the 65 evaluable patients per group for the primary endpoint.

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to compare the totally laparoscopic with the conventional approach in regard to intraoperative blood loss and need for perioperative blood transfusions (within first 24 hours after surgery). We hypothesise that intraoperative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group.

Secondary Outcome Measures

Name	Time	Method
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. Moreover an appraisal of patients as well as of physicians concerning the relevance of various outcome parameters will be evaluated as part of an additional scientific project in order to create a basis for further relevant research questions.