Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455501
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-15
Brief Title:
FOAM Functional Outcome After Ventral Mesh Rectopexy
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
FOAM Functional Outcome After Ventral Mesh Rectopexy Prospective Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rectal prolapse is a protrusion of rectal wall through the anus A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers
The goal of this trial is to investigate functional outcome recurrence rates and complications after ventral mesh rectopexy The main question it aims to answer is
- Do bowel function quality of life and sexual function improve after Ventral mesh rectopexy
Participants will
be asked to fill in questionaires before surgery 3-6 months after surgery and 12 months after surgery
be examined by a surgeon 3-6 months 12 months and 3 years after surgery
The goal of this trial is to investigate functional outcome recurrence rates and complications after ventral mesh rectopexy The main question it aims to answer is
- Do bowel function quality of life and sexual function improve after Ventral mesh rectopexy
Participants will
be asked to fill in questionaires before surgery 3-6 months after surgery and 12 months after surgery
be examined by a surgeon 3-6 months 12 months and 3 years after surgery
Detailed Description:
Several different procedures have been described for surgical treatment of rectal prolapse and a consensus has not yet been reached Over the past 20 years the use of Ventral mesh rectopexy to treat external rectal prolapse has gained increasing worldwide acceptance Ventral mesh rectopexy has become a standard procedure in many centers based on low recurrence rates limited complications and good functional results but the use and type of mesh have been debated Concerns have also been expressed regarding the choice of surgical technique which differs between centers and the lack of high-level evidence
There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated FOAM Functional Outcome After ventral Mesh rectopexy therefore aims to investigate bowel function quality of life sexual function recurrence rates and complications after ventral mesh rectopexy
A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden
There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated FOAM Functional Outcome After ventral Mesh rectopexy therefore aims to investigate bowel function quality of life sexual function recurrence rates and complications after ventral mesh rectopexy
A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None