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. (LATA-IBD)

December 11, 2025 updated by: Bjarne Melvas, Sahlgrenska University Hospital

LATA-IBD Trial a Laparoscopic and Transanal IPAA-surgery Trial.

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Study Design This is a prospective feasibility study comparing consecutive patients undergoing ta-IPAA with a historical cohort of patients treated with lap-IPAA at the same institution.

Endpoints The primary endpoints were conversion rate and anastomotic leakage rate. Conversion was defined as the need for laparotomy before pouch construction and/or specimen extraction, or the requirement to extend or alter the initial incision during pouch construction. Anastomotic leakage was defined and graded according to the International Study Group of Rectal Cancer (18).

Secondary endpoints included mortality, intraoperative bleeding, operative time, postoperative complications (graded according to the Clavien Dindo classification (19)), reoperations, readmissions, length of hospital stay and pouch function. Pouch function was assessed using the Öresland score (OS) (20) two years after surgery. The OS consists of 11 parameters measuring bowel function after IPAA and ranges from 0-15 (higher scores indicate worse function). Scores ≥8 are associated with impaired pouch function and reduced quality of life. Pouch failure was defined as the need for a diverting stoma or excision of the pouch.

Data collection Study data were collected prospectively using a paper case report form (CRFs) completed at predefined time points: preoperatively, intraoperatively, at hospital discharge and 3, 6, 12 and 24 months after ta-IPAA. For the historical control group, data were retrieved retrospectively from medical records. Intraoperative data were excluded from the lap-IPAA group, as these could not be reliably retrieved.

Training The surgical team consisted of three colorectal surgeons and experienced operating room nurses, all with prior expertise in laparoscopic Total Mesorectal Excision (TME) and IPAA-surgery. The team underwent formal training in taTME-surgery, including participation in dedicated courses, observational visits and on-site proctoring by an international center with significant experience in ta-IPAA.

Surgical Procedure The procedure began with takedown of the loop ileostomy. If mesenteric length was sufficient, the pouch was constructed immediately; otherwise, pouch construction was delayed until the abdominal phase, using either a midline or suprapubic incision. The abdomen was insufflated, and the mesentary was freed from adhesions and the duodenum. Mesenteric lengthening techniques were applied as required before constructing the ileal pouch.

Rectal dissection was performed in a modified TME plane, remaining closer to the rectum, particularly anteriorly, for the first two-thirds of the dissection. The transanal approach was used for the final third, employing standard equipment including the GelPOINT Path Transanal Access Platform®, Lone Star retractor®, and AirSeal® System. Dissection was performed with monopolar cautery, and the purse-string suture was placed with 3-0 V-Loc®. The rectum was extracted transanally or, if necessary, via an abdominal incision. The ileoanal anastomosis was constructed with a circular stapler, and a diverting stoma was created at the previous ileostomy site. (21)

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital/East department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria

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

Exclusion Criteria

- Not meeeting inclusion criteria above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate to open surgery
Time Frame: During surgery
Rate of patients with abdominal incision before pouch construction or changed or extended abdominal incision during pouch construction.
During surgery
Anastomotic leakage rate
Time Frame: Within 24 months after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Investigators

  • Principal Investigator: Hanna de la Croix, Associate professor, Sahlgrenska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2018

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2024-03692-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual patient data may be shared if needed but only if the secrecy of the patients is maintained. Data will be presented as group data in the publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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