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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | Patients will undergo 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal Transection and Single-Stapled anastomosis (TTSS) | Procedure | Restorative proctectomy with Transanal Transection and Single-Stapled (TTSS) Ileal Pouch-Anal Anastomosis (IPAA) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | 02 8224 7776 | 0039 | colorapp@humanitas.it |
| Stefano De Zanet, MS | Contact | 02 8224 4623 | 0039 | colorapp@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Humanitas Research Hospital | Rozzano | MI | 20089 | Italy |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Double-stapled anastomosis | Procedure | Restorative proctectomy with Tdouble-stapled Ileal Pouch-Anal Anastomosis (IPAA) |
|
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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |