Proctocolectomy Digestive System Familial polyposis or ulcerative colitis
Conditions
Interventions
This is an intra-operatively randomised, controlled single centre trial of patients with familial polyposis (FAP) or ulcerative colitis (UC) who undergo primary elective restorative proctocolectomy. I
Sponsors
University of Heidelberg Medical School (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Outcome results
None listed