Ulcerative Colitis
Conditions
Keywords
Ileal Pouch-Anal Anastomosis, Intestinal Function
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.
Interventions
Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA)
PROCEDUREDouble-stapled anastomosis
Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA)
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Patients with an incidental intraoperative diagnosis of colorectal cancer will be withdrawn from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pouch Function Score (PFS) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 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 |
| Anastomotic leak | 90 days after surgery | Rate difference of anastotic leaks between the study cohorts |
| Patients fit for stoma closure | 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 |
| Pouch Function Score (PFS) | 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 |
| Rectal cuff lenght | At surgery | Median difference of rectal cuff lenght (in cm) between the study cohorts |
| Pouch complications | 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. |
| Healthcare costs | 12 months after surgery | Median difference of healthcare costs (direct and indirect) between the study cohorts |
Countries
Italy
Contacts
Primary ContactAnnalisa Maroli, PhD
Backup ContactStefano De Zanet, MS
Outcome results
None listed