Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,817
- 试验地点
- 1
- 主要终点
- Successful obstetric fistula repair
研究概览
简要总结
The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.
详细描述
This is a prospective and retrospective chart review of a cohort of women aged 12 years and above who present to Bwaila Hospital with obstetric fistulas. Variables from existing subject records tracing back to January 2010 will be input into the REDCap database and analyzed. Prospective data collection will begin alongside obstetric fistula repairs upon IRB approval and will last for a minimum of 5 years.
A few variables were selected from the database for sample size determination:
- HIV prevalence In order to assess a statistically significant difference in HIV prevalence amongst fistula patients and the general population, with a projected prevalence of 25% in fistula patients and 15% in the general population based on prior studies, approximately 416 fistula patients would need to be enrolled in the study.
- Risk factors for failure of repair-Goh classification Type 4 In order to assess a statistically significant difference in failure of repair for fistula patients classified based on the Goh classification as Type4 (approximately 30% failure rate based on prior studies) and all other fistula patients (15% failure rate reported for uncomplicated fistulas), approximately 200 patients would need to be enrolled in the study.
It is estimated that about 200 fistula patients will be enrolled into the database every year. The study is expected to last a minimum of 5 years, for a total enrollment of 1250 patients.
Current Procedures For more than a year, the Freedom to Fight Fistula Foundation (FFFF) has sponsored a fistula repair program at Bwaila that has consisted of visiting fistula surgeons coming for short periods of time to conduct repairs. Since September 2011, a full time fistula surgeon has been on site at Bwaila hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 12 years and above
- •Present to Bwaila Hospital with obstetric fistula
- •Allow retrospective chart review
- •Willing to provide consent
排除标准
- •Not allow retrospective chart review
结局指标
主要结局
Successful obstetric fistula repair
时间窗: 3-months after obstetric fistula repair
Successful obstetric fistula repair is defined by having a negative dye test (no leakage of dye into the vagina after dye is infused into the bladder). Factors associated with successful obstetric fistula repair will be evaluated.
次要结局
- Rates of depression among women undergoing obstetric fistula repair and associated factors(3-months after obstetric fistula repair)