Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)
LONGOMUSSET
1 other identifier
interventional
11
1 country
1
Brief Summary
The surgical technique of Musset has shown its effectiveness for the cure of recto-vaginal fistulas. Recto-vaginal fistulas are mostly post-obstetric (88%). The objective of this study is to investigate the outcome of patients who underwent a Musset surgical technique, as well as their postoperative functional and anatomical results at a distance from the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
October 15, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedJanuary 11, 2023
January 1, 2023
2 months
October 5, 2021
January 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of gas and/or stool incontinence more than 6 months after surgery
To determine the anatomical and functional results in the long term after cure of recto vaginal fistula according to the Musset technique through questionnaire and auscultation
Day 1
Secondary Outcomes (6)
Questionnaire Short Form 36 (SF 36) (0 to 100)
Day 1
Questionnaire World Health Organization Quality of Life-Bref (WHOQOL-Bref) (0 to 100 in 4 fields)
Day 1
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)
Day 1
Questionnaire Sexual Activity Questionnaire (SAQ)
Day 1
Cleveland Score (0 to 20)
Day 1
- +1 more secondary outcomes
Study Arms (1)
surgical technique of Musset
OTHERInterventions
The one-stage rectovaginal fistula cure according to Musset is an intervention indicated in the treatment of simple post-obstetrical or simple post-surgical rectovaginal fistulas. The procedure consists in performing a perineal section to the perineal section to the fistula pathway in order to perform local excision followed by a repair plane by plane with rectal and anal closure, then of the external sphincter of the anus, and interposition of the deep and superficial transverse elevator and perineal muscles before closing the vagina and perineum.
Eligibility Criteria
You may qualify if:
- Patients who underwent Musset surgery between January 1, 2002 and December 31, 2020 in the Obstetrics and Reproductive Medicine Department of Intercommunal Hospital Center of Créteil
- Patients who gave their consent to participate in this study
- Patients affiliated with a social security plan
You may not qualify if:
- Patients who have undergone rectovaginal fistula treatment using a technique other than the Musset technique
- Patients lost to follow-up
- Patients under legal protection (guardianship, curatorship, safeguard of justice, family habilitation and mandate of future protection activated)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
October 15, 2021
Study Start
January 20, 2022
Primary Completion
March 24, 2022
Study Completion
March 24, 2022
Last Updated
January 11, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share