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Search / Trial NCT06331637

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

Launched by ISTITUTO CLINICO HUMANITAS · Mar 19, 2024

Trial Information

Current as of September 01, 2025

Not yet recruiting

Keywords

Ileal Pouch Anal Anastomosis Intestinal Function

ClinConnect Summary

This clinical trial is looking at two different surgical methods for treating Ulcerative Colitis (UC), a condition that causes long-term inflammation of the intestines. Specifically, it compares the Transanal Transection and Single-Stapled (TTSS) procedure with the Double-Stapled Ileal Pouch-Anal Anastomosis (IPAA). The goal is to see which method provides better outcomes in terms of surgery and recovery for patients who have not responded to medications or are relying on steroids to manage their UC.

To participate in this trial, patients must be at least 18 years old and have been diagnosed with UC that hasn't improved with standard treatments. They should also be scheduled for a type of surgery called restorative proctectomy, which is a procedure to remove the rectum and create a new pouch from the intestine. However, patients who are going to have open surgery or have colorectal cancer will not be eligible for this study. If you take part, you can expect to undergo one of the two surgical techniques being studied, and researchers will closely monitor your recovery and overall health outcomes afterward.

Gender

ALL

Eligibility criteria

  • 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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.

About Istituto Clinico Humanitas

Istituto Clinico Humanitas is a leading clinical research organization based in Italy, dedicated to advancing medical science through innovative clinical trials and research initiatives. With a strong emphasis on patient-centered care and cutting-edge methodologies, the institute collaborates with various stakeholders in the healthcare sector to develop and evaluate new therapies and treatment protocols. Its multidisciplinary team of experts is committed to ensuring the highest standards of ethical practice and scientific rigor, contributing to significant advancements in medical knowledge and improved patient outcomes.

Locations

Rozzano, Mi, Italy

Patients applied

0 patients applied

Trial Officials

Antonino Spinelli, MD, PhD

Principal Investigator

Humanitas Research Hospital IRCCS, Rozzano-Milan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported