Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559085
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Posterior Versus Lateral Laparoscopic Mesh Rectopexy for the Management of Complete Rectal Prolapse
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Aim of the study is to evaluate the outcomes of two different methods of mesh placement during laparoscopic rectopexy for the management of complete rectal prolapse lateral versus posterior mesh rectopexy
Detailed Description:
Rectal prolapse is the full-thickness prolapse of the rectum in which the rectum passes externally beyond the anal sphincters It is a somewhat rare condition estimated to occur in less than 05 of the population Rectal prolapse has a 91 female predominance and while it is occasionally seen in younger individuals the incidence increases with age
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches Traditionally a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years with mesh rectopexy being the most popular procedure
The mesh rectopexy operation was first described by Ripstein10 in 1952 Again after mobilization of the rectum an anterior sling of synthetic material either absorbable or non-absorbable is placed in front of the rectum and sutured to the sacral promontory The rationale for this is to restore the natural curve of the rectum which reduces the effect of downward abdominal pressure The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent returning the rectum to a normal anatomical position
The act of mobilization suture and fibrosis keeps the rectum fixed in position as adhesions form attaching the rectum to the presacral fascia Although SR is considered a good option for the cure of rectal prolapseIS in both men and women some reviews of this procedure noted a better overall clinical outcome in men This may be due to occult sphincter defects in women and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
Surgical approaches for rectal prolapse can be divided into perineal and abdominal approaches Traditionally a perineal procedure such as Delorme or Altemeir operation was commonly used in elderly or frail patients while an abdominal procedure such as rectopexy with or without resection was reserved for younger and fitter patients The frequency of laparoscopic abdominal repair of rectal prolapse has increased in recent years with mesh rectopexy being the most popular procedure
The mesh rectopexy operation was first described by Ripstein10 in 1952 Again after mobilization of the rectum an anterior sling of synthetic material either absorbable or non-absorbable is placed in front of the rectum and sutured to the sacral promontory The rationale for this is to restore the natural curve of the rectum which reduces the effect of downward abdominal pressure The use of a non-elastic synthetic graft provides a firm anterior fascial support even in patients with significant pelvic floor descent returning the rectum to a normal anatomical position
The act of mobilization suture and fibrosis keeps the rectum fixed in position as adhesions form attaching the rectum to the presacral fascia Although SR is considered a good option for the cure of rectal prolapseIS in both men and women some reviews of this procedure noted a better overall clinical outcome in men This may be due to occult sphincter defects in women and failure to detect these defects before surgery owing to the lack of routine endoanal ultrasonography in the earlier years of prolapse surgery
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