A systematic review of the patient burden of Crohn's disease-related rectovaginal and anovaginal fistulas

BMC Gastroenterol. 2022 Jan 28;22(1):36. doi: 10.1186/s12876-021-02079-8.

Kristy Iglay 1, Dimitri Bennett 2 3, Michael D Kappelman 4, Sydney Thai 5 6, Molly Aldridge 5, Chitra Karki 2, Suzanne F Cook 5


Author information

  • 1CERobs Consultancy LLC, Wrightsville Beach, NC, 27480, USA. kristy.iglay@laylen.com.
  • 2Takeda Pharmaceuticals, Cambridge, MA, 02139, USA.
  • 3Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA.
  • 4Chapel Hill School of Medicine, Pediatric Gastroenterology, University of North Carolina, Chapel Hill, NC, 27599, USA.
  • 5CERobs Consultancy LLC, Wrightsville Beach, NC, 27480, USA.
  • 6Gillings School of Public Health, Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, NC, 27599, USA.


Background: Crohn's disease (CD)-related rectovaginal fistulas (RVFs) and anovaginal fistulas (AVFs) are rare, debilitating conditions that present a substantial disease and treatment burden for women. This systematic literature review (SLR) assessed the burden of Crohn's-related RVF and AVF, summarizing evidence from observational studies and highlighting knowledge gaps.

Methods: This SLR identified articles in PubMed and Embase that provide data and insight into the patient experience and disease burden of Crohn's-related RVF and AVF. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies.

Results: Of the 582 records identified, 316 full-text articles were assessed, and 16 studies met a priori eligibility criteria and were included. Few epidemiology studies were identified, with one study estimating the prevalence of RVF to be 2.3% in females with Crohn's disease. Seven of 12 treatment pattern studies reported that patients had or required additional procedures before and/or after the intervention of interest, demonstrating a substantial treatment burden. Seven of 11 studies assessing clinical outcomes reported fistula healing rates between 50 and 75%, with varying estimates based on population and intervention.

Conclusions: This SLR reports the high disease and treatment burden of Crohn's-related RVF and AVF and identifies multiple evidence gaps in this field. The literature lacks robust, generalizable data, and demonstrates a compelling need for substantial, novel research into these rare and debilitating sequelae of CD. Registration The PROSPERO registration number for the protocol for this systematic literature review is CRD42020177732.



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