Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy
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ClinicalTrials.gov Identifier: NCT06117670 |
Recruitment Status :
Recruiting
First Posted : November 7, 2023
Last Update Posted : February 1, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectocele; Female Pelvic Organ Prolapse | Combination Product: posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | patients will undergo posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial |
Actual Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | January 1, 2025 |
Estimated Study Completion Date : | March 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: amniotic membrane graft
women with posterior vaginal prolapse will be enrolled and posterior colporrhaphy will be done with the application of sterilized (gamma irradiated) amniotic membrane as a graft.
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Combination Product: posterior colporrhaphy using gamma-irradiated amniotic membrane as a graft
Posterior colporrhaphy with application of the gamma-irradiated amniotic membrane graft will be done |
- POP-Q [ Time Frame: first week postoperative ]Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)
- POPDI-6 score [ Time Frame: at 3 months, and at 6 months postoperative ]Assessment of symptoms score using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) part of the Pelvic Floor Distress Inventory Short Form 20. Scale from 0 to 100, the higher score indicates worse condition.
- sexual satisfaction [ Time Frame: at 3 months, and at 6 months postoperative ]
to measure sexual satisfaction using female sexual function index questionnaire The Female Sexual Function Index (FSFI) was developed to assess six domains of female sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction, and pain).
Items are scored on a five-point Likert scale with low scores indicating lower levels of sexual functioning. Fifteen items also include a zero score as a sixth response option indicating no sexual activity in the past 4 weeks.
Range: 2 to 36.
- wound complications [ Time Frame: within 6 months postoperative ]Wound infection or wound dehiscence as detected clinically and /or CRP and vaginal swab as needed
- Intraoperative complications [ Time Frame: Intraoperative ]occurrence of intraoperative bladder or bowel injury
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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06117670
Contact: Rania HM Ahmed, MD | 01200522444 ext 202 | raneyah@med.asu.edu.eg | |
Contact: Nourhan A El-Sherbiny, MSc | 01006782554 ext 202 | nourhan.elsherbiny93@gmail.com |
Egypt | |
Ain Shams Maternity Hospital | Recruiting |
Cairo, Egypt | |
Contact: Rania H Mostafa Ahmed, MD 00201200522444 raneyah@gmail.com |
Study Chair: | Ihab FS Eldin Allam, MD | Ain Shams University | |
Study Director: | Ahmed M Abbas, MD | Ain Shams University |
Responsible Party: | Rania Hassan Mostafa, Dr, Ain Shams Maternity Hospital |
ClinicalTrials.gov Identifier: | NCT06117670 |
Other Study ID Numbers: |
FMASU MD81/2023 |
First Posted: | November 7, 2023 Key Record Dates |
Last Update Posted: | February 1, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | We plan to share the results, and the analytic code after publication of the study manuscript after the study has completed |
Supporting Materials: |
Study Protocol Analytic Code |
Time Frame: | Data will be available after publication, for 10years. |
Access Criteria: | data will be sent via e-mail upon reasonable request (raneyah@med.asu.edu.eg) |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
pelvic organ prolapse sexual satisfaction POP-Q |
Rectocele Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical Rectal Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Hernia |