Ulcerative Colitis Clinical Trial
— TTSS-PouchOfficial title:
Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
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)
Status | Not yet recruiting |
Enrollment | 174 |
Est. completion date | December 31, 2026 |
Est. primary completion date | July 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Humanitas Research Hospital | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 12 months after surgery or stoma closure | |
Secondary | 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 | 24 months after surgery or stoma closure | |
Secondary | Postoperative complications | 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 | 90 days after surgery | |
Secondary | Anastomotic leak | Rate difference of anastotic leaks between the study cohorts | 90 days after surgery | |
Secondary | Patients fit for stoma closure | 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 | 12 months after surgery | |
Secondary | Healthcare costs | Median difference of healthcare costs (direct and indirect) between the study cohorts | 12 months after surgery | |
Secondary | Rectal cuff lenght | Median difference of rectal cuff lenght (in cm) between the study cohorts | At surgery | |
Secondary | Pouch complications | 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. | 24 months after surgery or stoma closure |
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