Clinical trial NCT06331637: Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis
Official title: Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ileal Pouch-Anal Anastomosis
Intestinal Function
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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)

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.

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.

Primary outcomes:
measure: Pouch Function Score (PFS)
timeFrame: 6 months after surgery or stoma closure
Secondary outcomes:
measure: Pouch Function Score (PFS)
timeFrame: 12 months after surgery or stoma closure
measure: Pouch Function Score (PFS)
timeFrame: 24 months after surgery or stoma closure
measure: Postoperative complications
timeFrame: 90 days after surgery
measure: Anastomotic leak
timeFrame: 90 days after surgery
measure: Patients fit for stoma closure
timeFrame: 12 months after surgery
measure: Healthcare costs
timeFrame: 12 months after surgery
measure: Rectal cuff lenght
timeFrame: At surgery
measure: Pouch complications
timeFrame: 24 months after surgery or stoma closure
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: