IRCCS Humanitas Research Hospital
Rozzano, MI, 20089, Italy
Location contact
Annalisa Maroli, PhD
CONTACT
02 8224 7776 ext. 0039
Stefano De Zanet, MS
CONTACT
02 8224 4623 ext. 0039
NCT Number: NCT06331637
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)
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Rozzano, MI, 20089, Italy
Annalisa Maroli, PhD
CONTACT
02 8224 7776 ext. 0039
Stefano De Zanet, MS
CONTACT
02 8224 4623 ext. 0039
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)
Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)
Time frame: 6 months after surgery or stoma closure
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Time frame: 12 months after surgery or stoma closure
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Time frame: 24 months after surgery or stoma closure
Median difference of the Pouch Function Score (PFS) [score ranging from 0 (no pouch symptoms) to 30 (severe pouch symptoms)] between the study cohorts
Time frame: 90 days after surgery
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
Time frame: 90 days after surgery
Rate difference of anastotic leaks between the study cohorts
Time frame: 12 months after surgery
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
Time frame: 12 months after surgery
Median difference of healthcare costs (direct and indirect) between the study cohorts
Time frame: At surgery
Median difference of rectal cuff lenght (in cm) between the study cohorts
Time frame: 24 months after surgery or stoma closure
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.
Contact information is provided by the study sponsor or research team.
Annalisa Maroli, PhD
CONTACT
02 8224 7776 ext. 0039
Stefano De Zanet, MS
CONTACT
02 8224 4623 ext. 0039
Istituto Clinico Humanitas
Other
Postoperative and Functional Outcomes of Transanal Tran-section and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis in Ulcerative Colitis Patients
Acronym: TTSS-Pouch
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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