Back to resultsFunctional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
Primary Purpose
Rectocele, Obstructive Defecation Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic ventral mesh rectopexy
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele focused on measuring Anterior rectocele, laparoscopic ventral mesh rectopexy
Eligibility Criteria
Inclusion Criteria: multiparous female patients. aged between 30 and 60 years who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section. complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse Exclusion Criteria: paradoxical contraction of puborectalis muscle (anismus), complete external rectal prolapse fecal incontinence other benign anal conditions those who are unfit for surgery due to associated severe co-morbidities
Sites / Locations
- Ahmad
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
laparoscopic ventral mesh rectopexy arm
Arm Description
those who were underwent laparoscopic ventral mesh rectopexy for rectocele.
Outcomes
Primary Outcome Measures
changes in the Wexner constipation score
improvement in constipation, if the score is decreasing this means improving
Secondary Outcome Measures
sexual function changes
changes in the sexual function score post operative (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score(PISQ-12). The lower the score the better the function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05894226
Brief Title
Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
Official Title
Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.
Detailed Description
For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.
Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.
The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele, Obstructive Defecation Syndrome
Keywords
Anterior rectocele, laparoscopic ventral mesh rectopexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopic ventral mesh rectopexy arm
Arm Type
Experimental
Arm Description
those who were underwent laparoscopic ventral mesh rectopexy for rectocele.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic ventral mesh rectopexy
Intervention Description
patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele
Primary Outcome Measure Information:
Title
changes in the Wexner constipation score
Description
improvement in constipation, if the score is decreasing this means improving
Time Frame
6 months
Secondary Outcome Measure Information:
Title
sexual function changes
Description
changes in the sexual function score post operative (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score(PISQ-12). The lower the score the better the function.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
only female patients with anterior rectocele
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
multiparous female patients.
aged between 30 and 60 years
who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse
Exclusion Criteria:
paradoxical contraction of puborectalis muscle (anismus),
complete external rectal prolapse
fecal incontinence
other benign anal conditions
those who are unfit for surgery due to associated severe co-morbidities
Facility Information:
Facility Name
Ahmad
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
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