COMET (Composite Outcomes of Mesh vs suture Techniques for prolapse repair)- Protocol for a single blind randomized controlled multicenter trial testing surgical innovation in female pelvic surgery
There is a need for innovation to improve the surgical approach to vaginal apical suspension. Despite controversies with mesh, it has been shown to be safe when used appropriately and to have higher durability when compared with sutures. As well, the importance of restoring anatomy and tension-free surgical approach in pelvic reconstructive surgery has led to better long-term outcomes and fewer side effects. These principles have been applied when developing the novel BSSVF-M technique. Anticipated challenges of this trial include recruitment, compliance problems and loss to follow up However, the robust methodology will provide evidence on the best surgical approach to correct POP, a common condition among aging women.
Authors
- Ola Malabarey
- Maryse Larouche (ORCID: https://orcid.org/0000-0001-9942-5540)
- Wei Zhang (ORCID: https://orcid.org/0000-0002-5111-4097)
- Lori A. Brotto (ORCID: https://orcid.org/0000-0001-7552-8588)
- Lina Roa (ORCID: https://orcid.org/0000-0001-6552-4452)
- Momoe Hyakutake (ORCID: https://orcid.org/0000-0002-3222-9198)
- Nicole Koenig (ORCID: https://orcid.org/0000-0003-3668-6545)
- Roxana Geoffrion (ORCID: https://orcid.org/0000-0003-1194-0842)
- Erin A. Brennand
- Joel Singer (ORCID: https://orcid.org/0000-0002-7220-4382)
- Terry Lee (ORCID: https://orcid.org/0000-0003-2582-2337)
Institutions
- University of British Columbia (CA)
- University of Alberta (CA)
- University of Calgary (CA)
- McGill University (CA)
- McMaster University (CA)
Publication Details
- Journal
- PLoS ONE
- Published
- 2024-10-24
- DOI
- https://doi.org/10.1371/journal.pone.0308926
- Citations
- 5
- Primary Topic
- Pelvic floor disorders treatments
- Type
- article
- Field-Weighted Citation Impact
- 2.35
Funders
- Pfizer
- AbbVie
- Michael Smith Health Research BC
- Pfizer Canada
- Canadian Institutes of Health Research