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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-12-31

Brief Summary

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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)

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Detailed Description

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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

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transanal Transection and Single-Stapled anastomosis (TTSS)

Patients will undergo restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal anastomosis (IPAA)

Transanal Transection and Single-Stapled anastomosis (TTSS)

Intervention Type PROCEDURE

Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)

Double-stapled anastomosis

Patients will undergo restorative proctectomy with double-stapled Ileal Pouch-Anal anastomosis (IPAA)

Double-stapled anastomosis

Intervention Type PROCEDURE

Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)

Interventions

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Transanal Transection and Single-Stapled anastomosis (TTSS)

Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)

Intervention Type PROCEDURE

Double-stapled anastomosis

Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No