Fat Injection for Treatment of Rectocele a Novel Technique for Treatment of Tectocele
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Reduction in Rectocele Size
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of autologous fat grafting as a novel treatment for rectocele, a condition characterized by the herniation of rectal tissue into the posterior vaginal wall. Women aged 18 to 60 years with mild to moderate rectocele, presenting with symptoms such as obstructive defecation or vaginal bulge, will undergo submucosal fat injections. The study will assess the procedure's ability to alleviate symptoms and reduce prolapse recurrence. This prospective, single-arm trial will be conducted at Cairo University Hospitals.
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
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged between 18 and 60 years.
- •Diagnosis of rectocele confirmed by defecography, with a rectocele size of 2 cm (mild) to 4 cm (moderate).
- •Presenting with symptoms of obstructive defecation syndrome, including constipation, incomplete defecation, and/or vaginal bulge.
- •Able to provide written informed consent to participate in the study.
排除标准
- •Patients who have previously undergone surgical repair of rectocele.
- •Presence of thrombosed hemorrhoids.
- •History of sclerotherapy injection for rectocele.
- •Diagnosis of anal stenosis.
- •History of coagulopathy or current use of anticoagulant or antiplatelet medications.
- •Refusal or inability to provide informed consent.
结局指标
主要结局
Reduction in Rectocele Size
时间窗: 6 months post-procedure
The outcome will assess the reduction in rectocele size, measured by clinical examination and defecography. Improvement in rectocele grade will be quantified using a standardized rectocele grading scale. Rectocele Grading Scale: Grade 0: No prolapse of the rectal wall into the vaginal canal. Grade 1: Mild prolapse, where the rectal wall descends slightly into the vaginal canal, typically during straining, but does not reach the vaginal introitus. Grade 2: Moderate prolapse, where the rectal wall descends to the level of the vaginal introitus during straining or bowel movements. Grade 3: Severe prolapse, where the rectal wall protrudes beyond the vaginal introitus, visible externally, especially during straining. This scale would be used to assess the reduction in rectocele size over time as part of your primary outcome. You can adjust the wording in the outcome measure description to reflect this specific scale.
Symptom Relief
时间窗: 6 months post-procedure
In this we will evaluate the patient's relief from rectocele-associated symptoms, including vaginal bulge and obstructive defecation. This will be assessed using the Pelvic Floor Distress Inventory-20 (PFDI-20) questionnaire. The PFDI-20 measures the severity of pelvic floor symptoms on a scale of 0 to 4 for each item, with higher scores indicating greater distress. Unit of Measure: PFDI-20 Symptom Score (0-100, where 0 represents no distress and 100 represents maximum distress)
次要结局
- Rate of Recurrence of Rectocele(6 months post-procedure)
- Postoperative Pain(Up to 1 week post-procedure)
研究者
Eslam Mohamed Hagagy Mohamed
Resident of the General Surgery, Cairo University
Cairo University