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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS); Procedure: Double-stapled anastomosis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 174

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
• Study Contact Backup: Name: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • IRCCS Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
      • Contact: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transanal Transection and Single-Stapled anastomosis (TTSS); Patients will undergo restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal anastomosis (IPAA)	Procedure: Transanal Transection and Single-Stapled anastomosis (TTSS); 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)	Procedure: Double-stapled anastomosis; Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Anastomotic leak	Rate difference of anastotic leaks between the study cohorts	90 days after surgery
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
Healthcare costs	Median difference of healthcare costs (direct and indirect) between the study cohorts	12 months after surgery
Rectal cuff lenght	Median difference of rectal cuff lenght (in cm) between the study cohorts	At surgery
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinelli, MD, PhD, IRCCS Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Ileal Pouch-Anal Anastomosis; Intestinal Function
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 3782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No