Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy

Launched by AIN SHAMS MATERNITY HOSPITAL · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of tissue called gamma-irradiated amniotic membrane to help repair the posterior vaginal wall in women who have a condition known as rectocele, which is when the front wall of the rectum bulges into the vagina. The main goal is to find out if using this tissue during surgery makes the repair more effective. Women between the ages of 30 and 60 who have been diagnosed with this condition and are planning to have surgery may be eligible to participate.

If you join the trial, you will undergo a surgical procedure called posterior colporrhaphy, where the gamma-irradiated amniotic membrane will be added to help support the repair. However, there are some important criteria for eligibility. For example, you should not have certain health conditions that could complicate surgery, such as severe anemia or uncontrolled medical disorders. This trial is currently recruiting participants, so if you or someone you know fits the eligibility criteria and is interested, it could be a good opportunity to help improve treatment options for this common issue.

Gender

FEMALE

Eligibility 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).