Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy
Egypt25 participantsStarted 2023-11-01
Plain-language 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 aims to answer is:
• Is posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft effective?
Participants will undergo posterior colporrhaphy, which will be modified by adding gamma-irradiated amniotic membrane as a graft during the repair.
Who can participate
Age range
30 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
POP-Q
Timeframe: first week postoperative
2
POPDI-6 score
Timeframe: at 3 months, and at 6 months postoperative