Using gamma-irradiated amniotic membrane for pelvic surgery
Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
This study is testing whether using a special graft made from gamma-irradiated amniotic membrane during surgery can help women with rectocele recover better from pelvic organ prolapse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | Female |
| Sponsor | Ain Shams Maternity Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06117670 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of gamma-irradiated amniotic membrane as a graft during posterior colporrhaphy for women with posterior vaginal wall defects, specifically rectocele. Participants will undergo a surgical procedure where the graft is applied to enhance the repair of pelvic organ prolapse. The study will involve thorough patient assessments, including medical history, pelvic examinations, and preoperative tests to ensure eligibility. The primary outcome is to determine the success of this innovative grafting technique in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 30-60 with a diagnosis of posterior vaginal wall prolapse and a BMI between 20-35.
Not a fit: Patients with immunocompromising conditions, severe anemia, or uncontrolled medical disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and quality of life for women suffering from pelvic organ prolapse.
How similar studies have performed: While the use of amniotic membrane in surgical procedures has been explored, this specific application in posterior colporrhaphy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Cairo
- Ain Shams Maternity Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Rania HM Ahmed, MD
- Email: raneyah@med.asu.edu.eg
- Phone: 01200522444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.