CompletedPhase 3

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 range30 Years – 60 Years

SexFEMALE

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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).

What they're measuring

POP-Q

Timeframe: first week postoperative

POPDI-6 score

Timeframe: at 3 months, and at 6 months postoperative

Trial details

NCT IDNCT06117670

SponsorAin Shams Maternity Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-05

View on ClinicalTrials.gov More Rectocele; Female trials