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 | Completed

• 1 other identifier: Dnr 2024-03692-02
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

ulcerative colitis; laparoscopy; transanal surgery; pelvic pouch

Outcome Measures

Primary Outcomes (2)

• Conversion rate to open surgery

  Rate of patients with abdominal incision before pouch construction or changed or extended abdominal incision during pouch construction.

  During surgery

• Anastomotic leakage rate

  Rate of anastomotic leakage as defined by the international study group of cancer. A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments.

  Within 24 months after surgery

Study Arms (2)

22 Patients operated with transanal laparoscopic IPAA

Proaspecticely collected data with paper case report form

17 Patients operated with conventional laparoscopic IPAA

Retrospectively collected data from medical records

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients aged \>18 years with a diagnosis of ulcerative colitis (UC) or familial adenomatous polyposis (FAP) scheduled for lap-IPAA between 2018 and 2020 at Sahlgrenska University Hospital were invited to participate. A minimum sample size of 20 patients was considered sufficient to evaluate the feasibility of introducing the ta-IPAA technique. For comparison, a historical control group of 17 patients who underwent lap-IPAA between 2015 and 2016 was identified.

You may qualify if:

• years and over.
• UC or FAP.
• Fit for laparoscopic IPAA-surgery
• Signed informed consent.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital/East department

Gothenburg, Sweden

Location

Related Publications (4)

• Deng SX, Brar MS, Yang ML, Park JJ, de Buck van Overstraeten A. Functional outcomes of transanal ileal pouch anal anastomosis in patients with ulcerative colitis: inverse-probability weighing analysis of a single-center cohort. J Gastrointest Surg. 2025 Oct;29(10):102189. doi: 10.1016/j.gassur.2025.102189. Epub 2025 Aug 13.

  PMID: 40816645 BACKGROUND

• Stephens IJB, Byrnes KG, Burke JP. Transanal ileal pouch-anal anastomosis: A systematic review and meta-analysis of technical approaches and clinical outcomes. Langenbecks Arch Surg. 2024 May 6;409(1):153. doi: 10.1007/s00423-024-03343-7.

  PMID: 38705912 BACKGROUND

• de Buck van Overstraeten A, Mark-Christensen A, Wasmann KA, Bastiaenen VP, Buskens CJ, Wolthuis AM, Vanbrabant K, D'hoore A, Bemelman WA, Tottrup A, Tanis PJ. Transanal Versus Transabdominal Minimally Invasive (Completion) Proctectomy With Ileal Pouch-anal Anastomosis in Ulcerative Colitis: A Comparative Study. Ann Surg. 2017 Nov;266(5):878-883. doi: 10.1097/SLA.0000000000002395.

  PMID: 28742696 BACKGROUND

• Violante T, Broccard SP, Novelli M, Stocchi L, Colibaseanu DT, DeLeon MF, Behm KT, Mishra N, Larson DW, Merchea A. Comparative analysis of robotic, laparoscopic, and open ileal pouch-anal anastomosis outcomes: retrospective cohort study. BJS Open. 2025 Jul 1;9(4):zraf084. doi: 10.1093/bjsopen/zraf084.

  PMID: 40742352 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Adenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hanna de la Croix, Associate professor

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant,

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 12, 2025
• Study Start: April 18, 2018
• Primary Completion: January 31, 2021
• Study Completion: March 30, 2023
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

SE (1)