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Clinical Trials in Italy / NCT06331637
Starting soon Observational

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

NCT06331637 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Clinico Humanitas
Phase
Observational
Started
2024-07-31
Last updated
2024-03-26

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

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

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

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

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
IRCCS Humanitas Research Hospital Rozzano MI

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Other trials for the same condition

Development of Novel Imaging and Molecular Biomarkers of Fibrosis in Patient With Ulcerative Colitis Recruiting
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) Active, not recruiting
Estimation of Cardiovascular Risk in Patients With Crohn's Disease and Ulcerative Colitis (PROVACI) Enrolling by invitation
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06331637 on ClinicalTrials.gov ↗ ← All trials in Italy