Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis
Observational · No treatment assigned · 1 site · Istituto Clinico Humanitas
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 174 participants are expected to take part.
- Start date: 2024-07-31 (planned).
- Main results expected around 2026-07-31 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- Pouch Function Score (PFS) (6 months after surgery or stoma closure)
In the researchers’ words
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)
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Istituto Clinico Humanitas |
| Enrollment | 174 (estimated) |
| Start date | 2024-07-31 |
| Primary completion (est.) | 2026-07-31 |
| First posted | 2024-03-26 |
| Last updated | 2024-03-26 |
| Official title | Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients |
| ClinicalTrials.gov ID | NCT06331637 |
Interventions
- 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)
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Humanitas Research Hospital | Rozzano, MI | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.