Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522399
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Outcome of TAMIS Mucosal Resection in Patients With ODS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcome of Transanal Minimally Invasive TAMIS Mucosal Resection in Patients With Obstructed Defecation Syndrome - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients aged 18 - 90 years undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study
Primary endpoint is the outcome improvement of ODS symptoms defined by ODS score
Primary endpoint is the outcome improvement of ODS symptoms defined by ODS score
Detailed Description:
Various surgical approaches for the treatment of obstructed defecation syndrome ODS commonly associated with rectocele and rectal intussusception have been investigated in the literature Methods such as stapled transanal resection of the rectum STARR and ventral prosthesis rectopexy VPR show promising results at least in the short term In the long-term however the results do not seem convincing Schiano di Visconte et al report a recurrence of ODS symptoms in 40 percent of the patients treated with stapled transanal rectal resection in a 10-year follow up The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery TAMIS in the sense of a mucosal resection without stapling technique has not yet been investigated This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None