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Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET) (LONGOMUSSET)

Primary Purpose

Rectovaginal Fistula, Obstetric Complication

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgical technique of Musset
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectovaginal Fistula focused on measuring surgical technique of Musset

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Centre Hospitalier Intercommunal de Créteil

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

surgical technique of Musset

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Questionnaire Short Form 36 (SF 36) (0 to 100)
Assessment of quality of life and overall satisfaction through validated questionnaire
Questionnaire World Health Organization Quality of Life-Bref (WHOQOL-Bref) (0 to 100 in 4 fields)
Assessment of mental health through validated questionnaire
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)
Assessment of sexual quality of life through validated questionnaire
Questionnaire Sexual Activity Questionnaire (SAQ)
Assessment of sexual quality of life through validated questionnaire
Cleveland Score (0 to 20)
Evaluation of the quality of the anatomical restitution through validated questionnaire
Patient Global Impression and Improvement (PGI-I) (1 to 7)
Evaluation of the global impression and improvement to describe as best as possible how your problems are now, compared to how they were compared to what they were before the treatment.

Full Information

First Posted
October 5, 2021
Last Updated
January 10, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
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1. Study Identification

Unique Protocol Identification Number
NCT05079139
Brief Title
Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)
Acronym
LONGOMUSSET
Official Title
Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obstetric fistulas affect more than 2 million women worldwide with 50,000 to 100,000 cases per year and are responsible for symptoms that can alter the quality of life. Among fistulas, recto-vaginal fistulas are responsible for disabling symptoms such as the emission of gas and/or stool through the vagina, local infections with purulent and/or malodorous discharge from the vagina, and even dyspareunia. These disabling symptoms constitute a real psycho-social burden for the patients who suffer from them as demonstrated in the study of Singh et al. carried out in India where up to 79.5% felt socially isolated. In developing countries, women with fistula are often abandoned by their husbands and rejected by their families and communities. Recto-vaginal fistulas are mostly post-obstetric (88%). Indeed, in a study by Goldaber et al. of 24,000 vaginal births, an incidence of 1.7% of grade 4 tears and 0.5% of recto-vaginal fistulas was noted. However, recto-vaginal fistulas can be related to other causes: local infection, post-traumatic (violence, surgery), chronic inflammatory bowel disease (Crohn's ++), radiotherapy, carcinoma or congenital. The surgical technique of Musset, initially described in 1963, has shown its effectiveness for the cure of recto-vaginal fistulas. In Soriano's retrospective study, 48 patients had undergone recto-vaginal fistula repair using the Musset surgical technique: 25 of the fistulas were of obstetrical origin, 11 of infectious origin, 7 in the context of inflammatory bowel disease and 3 post-surgical. Of the 48 patients, 63% had a history of recto-vaginal fistula treatment, 85% had gas incontinence and 75% had stool incontinence. A total of 47 patients had a satisfactory anatomical and functional outcome with a success rate of 100% for post chronic inflammatory bowel disease fistulas and 98% for patients with a surgical history. Since then, the indication for this procedure has been extended to the treatment of obstetrical perineal sequelae with damage to the external sphincter. In this case, the procedure is usually done in one operation and not two as initially described. Although this condition affects a significant number of women (mainly in developing countries), few large studies have looked at the results of this technique and the literature is still relatively poor. In particular, no study has looked at the long-term and very long-term results of this surgical technique to definitively demonstrate its benefit, which is all the more fundamental as this pathology essentially affects young women. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectovaginal Fistula, Obstetric Complication
Keywords
surgical technique of Musset

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Descriptive study
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
surgical technique of Musset
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
surgical technique of Musset
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of gas and/or stool incontinence more than 6 months after surgery
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Questionnaire Short Form 36 (SF 36) (0 to 100)
Description
Assessment of quality of life and overall satisfaction through validated questionnaire
Time Frame
Day 1
Title
Questionnaire World Health Organization Quality of Life-Bref (WHOQOL-Bref) (0 to 100 in 4 fields)
Description
Assessment of mental health through validated questionnaire
Time Frame
Day 1
Title
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)
Description
Assessment of sexual quality of life through validated questionnaire
Time Frame
Day 1
Title
Questionnaire Sexual Activity Questionnaire (SAQ)
Description
Assessment of sexual quality of life through validated questionnaire
Time Frame
Day 1
Title
Cleveland Score (0 to 20)
Description
Evaluation of the quality of the anatomical restitution through validated questionnaire
Time Frame
Day 1
Title
Patient Global Impression and Improvement (PGI-I) (1 to 7)
Description
Evaluation of the global impression and improvement to describe as best as possible how your problems are now, compared to how they were compared to what they were before the treatment.
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)

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