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NCT Number: NCT06331637

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.

Treatment and study plan

Transanal Transection and Single-Stapled anastomosis (TTSS)

Procedure

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

Double-stapled anastomosis

Procedure

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

Primary outcomes

  1. Pouch Function Score (PFS)

    Time frame: 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 outcomes

  1. Pouch Function Score (PFS)

    Time frame: 12 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

  2. Pouch Function Score (PFS)

    Time frame: 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

  3. Postoperative complications

    Time frame: 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

  4. Anastomotic leak

    Time frame: 90 days after surgery

    Rate difference of anastotic leaks between the study cohorts

  5. Patients fit for stoma closure

    Time frame: 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

  6. Healthcare costs

    Time frame: 12 months after surgery

    Median difference of healthcare costs (direct and indirect) between the study cohorts

  7. Rectal cuff lenght

    Time frame: At surgery

    Median difference of rectal cuff lenght (in cm) between the study cohorts

  8. Pouch complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Maroli, PhD

CONTACT

[email protected]

02 8224 7776 ext. 0039

Stefano De Zanet, MS

CONTACT

[email protected]

02 8224 4623 ext. 0039

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: TTSS-Pouch

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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