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

I

Istituto Clinico Humanitas

Status

Not yet enrolling

Conditions

Ulcerative Colitis

Treatments

Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS)
Procedure: Double-stapled anastomosis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Full 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.

Enrollment

174 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.

Trial design

174 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Stefano De Zanet, MS; Annalisa Maroli, PhD

Data sourced from clinicaltrials.gov

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