Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis
TTSS-Pouch
Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
1 other identifier
observational
174
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 26, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 26, 2024
March 1, 2024
2 years
March 19, 2024
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pouch Function Score (PFS)
Median difference of the Pouch Function Score (PFS) \[score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)\] between the study cohorts
6 months after surgery or stoma closure
Secondary Outcomes (8)
Pouch Function Score (PFS)
12 months after surgery or stoma closure
Pouch Function Score (PFS)
24 months after surgery or stoma closure
Postoperative complications
90 days after surgery
Anastomotic leak
90 days after surgery
Patients fit for stoma closure
12 months after surgery
- +3 more secondary outcomes
Study Arms (2)
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
Patients will undergo restorative proctectomy with double-stapled Ileal Pouch-Anal anastomosis (IPAA)
Interventions
Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)
Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)
Eligibility Criteria
The study population will include adult patients diagnosed with drug-refractory and/or steroid-dependent Ulcerative Colitis (UC), scheduled for pouch surgery with double-stapled or Transanal Transection and Single-Stapled (TTSS) approach.
You may qualify if:
- 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
You may not qualify if:
- Planned open surgery.
- Concomitant colorectal cancer or dysplasia. Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonino Spinelli, MD, PhD
Humanitas Research Hospital IRCCS, Rozzano-Milan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
March 26, 2024
Study Start
July 31, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 26, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share