Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633172
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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:
RCT
Brief Summary:
This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes
Detailed Description:
Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties straining at defecation manually assisted defecation the need for perineal or vaginal digitation and local symptoms such as vaginal bulging and pelvic heaviness in 30-70 of cases have been described as symptoms of rectocele
Constipation can be managed with dietary measures laxatives and biofeedback training which can be beneficial for patients with modest symptoms Surgical treatment is recommended if conservative treatment fails to alleviate symptoms However some patients may be left with constipation fecal incontinence incomplete bowel evacuation or sexual dysfunction despite the correction of the anatomical defect The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate
There is still a controversy between abdominal approaches and the transanal transperineal and transvaginal approaches as the optimal surgical approach to treat complex rectocele While the latter is preferred by gynecologists the former has increased in popularity among colorectal surgeons aided in part by the growing interest in minimally invasive surgery
This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life surgical outcomes and postoperative complications
Constipation can be managed with dietary measures laxatives and biofeedback training which can be beneficial for patients with modest symptoms Surgical treatment is recommended if conservative treatment fails to alleviate symptoms However some patients may be left with constipation fecal incontinence incomplete bowel evacuation or sexual dysfunction despite the correction of the anatomical defect The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate
There is still a controversy between abdominal approaches and the transanal transperineal and transvaginal approaches as the optimal surgical approach to treat complex rectocele While the latter is preferred by gynecologists the former has increased in popularity among colorectal surgeons aided in part by the growing interest in minimally invasive surgery
This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life surgical outcomes and postoperative complications
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