Fistula Formation and Successful Repair
Condition: Fistula; HIV
MeSH terms: Fistula
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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:

        1. 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.

        2. 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.

      Referral to the FFFF at Bwaila occurs primarily via word-of-mouth, as currently demand highly
      exceeds capacity. As of now, there is a waiting list of approximately 50 fistula patients.
      Occasionally, the foundation makes visits to health centers to give educational presentations
      on obstetric fistulas, and distributes flyers advertising its services in the local
      community. Once the presence of a regular surgeon is established, and the waiting list is
      diminished, the foundation anticipates increasing its advertising through newspaper and
      radio, and by making regular visits to community events and district health centers.

      Bwaila Hospital is a hospital located in Lilongwe designated for women. It provides basic,
      regular obstetric and gynecologic services.

      Data Collection and Bwaila Hospital

      Retrospective Arm A chart review of existing subject records tracing back to January 2010
      will be conducted, and input in the REDCap database to the extent that it is available and
      complete.

      Prospective Arm Nurses will obtain informed consent from all patients admitted to Bwaila
      Hospital for obstetric fistula evaluation to participate in the research study.

      They will then interview the patients with a clinical history form. The information collected
      with the form will be relevant to the care of the patient, and is part of routine care for
      obstetric fistula patients.

      The form includes demographic data, sexual history, obstetric history, and medical history,
      and a depression screening and diagnostic tool.

      After the interview the patient will receive standard of care with their obstetrics doctor
      for their fistulas (this is not part of the study): assessed for the presence of an obstetric
      fistula; discuss possible repair; have repair; recuperate; discharged; return for follow-up
      visits at one month and three months to assess how the patient is doing.

      At these visits patient will have 5 minute study interviews discussing their ability to
      control their urination, and also how well they are getting by in their community, both
      financially and socially.

      Additional data will be extracted directly from the patient chart as a secondary chart review
      for the study, and will include a review of physical exam findings, preoperative findings,
      intraoperative findings, postoperative results and follow-up findings at the one-month and
      three-month review dates.

      This data will be transferred from the patient charts to REDCap. All information collected
      will be de-identified.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants are women admitted to Bwaila Hospital for repair of obstetric fistulas.
      
Keywords: retrospective chart review; prospective chart review; fistula formation and repair; database; demographics of women with fistulas; internationally accepted risks factors for fistula formation