Status:
COMPLETED
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy
Lead Sponsor:
Ain Shams Maternity Hospital
Conditions:
Rectocele; Female
Pelvic Organ Prolapse
Eligibility:
FEMALE
30-60 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to test the benefit of using gamma-irradiated amniotic membrane as a graft in surgical repair for women with posterior vaginal wall defects. The main question it aim...
Detailed Description
• Methodology: 1. Protocol approval will be sought from the research ethical committee. 2. Enrolment: The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Mate...
Eligibility Criteria
Inclusion
- Women diagnosed as posterior vaginal wall prolapse: bulging of front wall of rectum into the vagina due to weakening of pelvic support system and thinning of rectovaginal septum.
- Women aged 30-60 years.
- BMI 20-35 kg/m2
- Planned for surgical correction
Exclusion
- Patients with:
- Immuno-compromise e.g. Patients receiving chemotherapy, steroids.
- Severe anaemia (Hb\<10)
- conditions that require concomitant reconstructive pelvic floor surgery e.g., anterior and/or apical compartment prolapse.
- Conditions that lead to increase intra-abdominal pressure e.g.,chronic obstructive pulmonary disease.
- Uncontrolled medical disorders (diabetes, hypertension, asthma).
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06117670
Start Date
November 1 2023
End Date
August 5 2025
Last Update
December 2 2025
Active Locations (1)
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1
Ain Shams Maternity Hospital
Cairo, Egypt