LATA-IBD TRIAL a Controlled Feasibility Study for the Introduction of Transanal Minimally Invasive IPAA-Surgery. Evaluation of Operative Results and Bowel Function After Introducing Transanal IPAA-surgery to Replace Conventional Laparoscopic IPAA-surgery.
NCT07278687 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39
Last updated 2025-12-12
Summary
This study compares the operative and functional outcomes of adding a transanal pathway to laparoscopic pelvic pouch surgery. The transanal pathway enables the surgeon to have better control when dividing the rectum and it may improve visualization in pelvic dissection. This could decrease the need for conversion to open surgery, reduce complications, postoperative pain, hospital stay and improve bowel function after surgery. The study compares two consecutive groups of patients at a single institution. The transanally operated group consists of 22 patients with prospectively collected data between 2018-2020 and the traditional laparoscopic group consists of 17 patients with retrospectively collected data operated between 2015-2016. Inclusion criteria for the transanal group were patients over 18 years with either ulcerative colitis or familial adenomatous polyposis who were possible to operate with laparoscopic surgery and who had signed an informed consent.
The studys primary objective is to investigate if there is a difference in the frequency of conversions to open surgery or anastomotic leakage of the anastomosis between the pelvic pouch and the anal canal. Secondary objectives are mortality, bleeding, operative time, complications, reoperations, hospital stay, readmissions to hospital and bowel function two years after surgery.
Conditions
- Ulcerative Colitis (Disorder)
- Familial Adenomatous Polyposis (FAP)
Sponsors & Collaborators
-
Sahlgrenska University Hospital
lead OTHER
Principal Investigators
-
Hanna de la Croix, Associate professor · Sahlgrenska University Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-18
- Primary Completion
- 2021-01-31
- Completion
- 2023-03-30
Countries
- Sweden
Study Locations
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