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

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS); Procedure: Double-stapled anastomosis

• Registration Number: NCT06331637
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Study Start: 2024-07-31
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Adult (≥ 18 years old) patients diagnosed with drug-refractory and/or steroid-dependent UC scheduled for elective restorative proctectomy.
• Patients scheduled for robotic or laparoscopic surgery

Exclusion Criteria

• Planned open surgery.
• Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transanal Transection and Single-Stapled anastomosis (TTSS)	Transanal Transection and Single-Stapled anastomosis (TTSS)	Patients will undergo restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal anastomosis (IPAA)
Double-stapled anastomosis	Double-stapled anastomosis	Patients will undergo restorative proctectomy with double-stapled Ileal Pouch-Anal anastomosis (IPAA)

Primary Outcome Measures

Name	Time	Method
Pouch Function Score (PFS)	6 months after surgery or stoma closure	Median difference of the Pouch Function Score (PFS) \[score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)\] between the study cohorts

Secondary Outcome Measures

Name	Time	Method
Patients fit for stoma closure	12 months after surgery	Proportion difference of patients fit for stoma closure in the study cohorts. Patients fit for stoma closure have already closed the stoma or have an intact anastomosis as demonstrated by a water contrast enema, Computed Tomography (CT) scan, endoscopic, or surgical revision
Pouch complications	24 months after surgery or stoma closure	Incidence rate difference of pouch complications or defunction- defined as any condition affecting the pouch function or requiring the pouch breakdown, including acute or chronic pouchitis, cuffitis, Crohn's disease of the pouch, or any other inflammatory condition - between the study cohorts.
Pouch Function Score (PFS)	24 months after surgery or stoma closure	Median difference of the Pouch Function Score (PFS) \[score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)\] between the study cohorts
Postoperative complications	90 days after surgery	Rate difference of postoperative complications, classified according to the Clavien-Dindo scale \[ranging from 0 (no complications) to 5 (complications leading to death)\] between the study cohorts
Anastomotic leak	90 days after surgery	Rate difference of anastotic leaks between the study cohorts
Healthcare costs	12 months after surgery	Median difference of healthcare costs (direct and indirect) between the study cohorts
Rectal cuff lenght	At surgery	Median difference of rectal cuff lenght (in cm) between the study cohorts

Trial Locations

Locations (1)

IRCCS Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy