NCT06331637

Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis

Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 174 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA)

Detailed description

Ileal Pouch-Anal Anastomosis (IPAAI in Ulcerative Colitis (UC) patients is usually performed by double-stapling technique after rectal transection with a linear stapler. Double-stapling is increasingly criticized for the uneven longer cuffs and potential weak points. The Transanal Transection and Single-Stapled (TTSS) approach may potentially overcome the limitations of double-stapling. A single-stapled anastomosis may be accomplished through a transanal rectal transection followed by bottom-up dissection (transanal-ileal pouch-anal anastomosis) or through an abdominal, rectal dissection and subsequent transanal transection and single-stapled anastomosis. TTSS-IPAA approach was shown to provide reduced rectal cuff length and reduced rate of urgency at six months after stoma closure. However, the retrospective and single-center features of these findings may prevent a robust conclusion about the superiority of TTSS-IPAA. The purpose of this study is to compare short-term and functional outcomes of double-stapling versus TTSS techniques for IPAA in UC patients in a prospective multicentric cohort study.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
PROCEDURE	Transanal Transection and Single-Stapled anastomosis (TTSS)	Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)
PROCEDURE	Double-stapled anastomosis	Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)

Timeline

• Start date: 2024-07-31
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2024-03-26
• Last updated: 2024-03-26

Locations

1 site across 1 country: Italy