Gamma-irradiated Amniotic Membrane Graft in Posterior Colporrhaphy. A Pilot One Arm Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- POP-Q
研究概览
简要总结
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.
详细描述
• Methodology:
- Protocol approval will be sought from the research ethical committee.
- Enrolment: The patients will be recruited from the outpatient gynecology clinic of Ain Shams University Maternity Hospital (ASUMH).
- History, examination, and routine investigations will be done to identify eligible patients.
History taking including (personal history, age, menopausal, medical history, and surgical history), as well as symptoms score using Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) part of the Pelvic Floor Distress Inventory Short Form 20. Also, sexual function will be assessed by Female Sexual Function Index Questionnaire.
Clinical examination: including (general examination, abdominal examination and pelvic examination and POP-Q.
Routine investigations: complete blood count and other preoperative tests as needed. 4. Written informed consent will be sought from the patients after proper counseling. 5. Surgical procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
POP-Q
时间窗: first week postoperative
Prolapse assessment using the prolapse quantification system of the International Continence Society (POP-Q)
POPDI-6 score
时间窗: 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.
次要结局
- sexual satisfaction(at 3 months, and at 6 months postoperative)
- wound complications(within 6 months postoperative)
- Intraoperative complications(Intraoperative)
研究者
Rania Hassan Mostafa
Dr
Ain Shams Maternity Hospital