Fistula Clinical Trial - Recurrence & Pregnancy Post-repair of Obstetric

Status Completed

Clinical Trial Summary

Obstetric fistula, also called vaginal fistula, is a serious medical condition which affects women in low income countries. Despite the strengthening of research on fistula, there is little data on the follow-up after fistula repair.

The objective of this study is to analyse the factors associated with the recurrence of fistula and the outcomes of pregnancy following fistula repair in Guinea. It will target women who got a closed fistula at discharge after repair in 2012/2015 at three fistula repair sites supported by the Fistula Care Project in Guinea (Kissidougou Prefectoral Hospital, Labé Regional Hospital and Jean Paul II Hospital of Conakry).

The outcomes of interest are fistula recurrence and pregnancy. The predictors of interest will include patient characteristics, fistula characteristics, the context of repair and the context of reintegration.

Participants giving an informed consent after a home visit by the Fistula Counsellors who managed women during surgery will be interview at enrolment and every six month from inclusion. The study duration is estimated at 48 months (January 2012 to March 2016) including the retrospective part.

A sample size of 364 women will estimate the recurrence of fistula with a plus/minus 2% margin of error (width of confidence interval is 4%) and 95% confidence interval and is sufficient to estimate the rate of pregnancy with a two-sided 95% confidence interval and 10% precision.

The cumulative incidence rate of fistula recurrence will be calculated using Kaplan-Meier methods and the risk factor analysis will be performed using adjusted cox regression.

For the outcomes of pregnancy, Pearson's Chi Square (χ2) will be used to compare proportions of pregnancy outcomes between potential predictors and logistic regression models will be used and associations will be reported as risk ratios with 95% confidence intervals.

Analysis will be done using STATA version 13 (STATA Corporation, College Station, TX, USA) with a level of significance set at P<0.05.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02686957
Study type	Observational
Source	Centre National de Formation et de Recherche en Sante Rurale
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	June 30, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02685878` - Outcomes of Women After Obstetric Fistula Repair
Completed	`NCT02962141` - A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO	N/A
Completed	`NCT02770352` - Fistula Formation and Successful Repair
Recruiting	`NCT01388257` - Anal Crohn Fistula Surgery	N/A
Completed	`NCT00544492` - Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients	Phase 4
Recruiting	`NCT05616104` - FLEX FIRST Registry Research Protocol
Completed	`NCT00500968` - Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail	N/A
Completed	`NCT05602987` - Comparison Study of the Effect of Enema in Anal Surgery	N/A
Recruiting	`NCT04543539` - IN.PACT™ AV Access Post-Approval Study (PAS002)
Terminated	`NCT01321866` - Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients	N/A
Recruiting	`NCT05766566` - Treatment of Perianal Fistulas in Crohn's Disease With Autologous Microfragmented Adipose Tissue With the Lipogems System
Withdrawn	`NCT03685955` - Efficacy of Amniotic Membranes in Complex Genitourinary Reconstruction
Completed	`NCT02374762` - Hemodialysis Vascular Access Imaging Study	N/A
Not yet recruiting	`NCT04774588` - HoloStream Study - Video Capture Device Usage	N/A
Completed	`NCT03120689` - VITOM Study: A Randomized, Controlled Trial.	N/A
Completed	`NCT01144962` - Dose-escalating Therapeutic Study of Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulas in Patients With Refractory Perianal Crohn's Disease	Phase 1/Phase 2
Not yet recruiting	`NCT00653094` - An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease	N/A
Active, not recruiting	`NCT05418816` - SelfWrap-Assisted Arteriovenous Fistulas	N/A
Withdrawn	`NCT04073472` - Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's	Phase 1
Completed	`NCT04978090` - Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Recurrence and Pregnancy Post-repair of Obstetric Fistula in Guinea

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms