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

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.

Study Overview

• Status: Completed
• Conditions: Rectovaginal Fistula; Obstetric Complication
• Intervention / Treatment: Procedure: surgical technique of Musset

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Centre Hospitalier Intercommunal de Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: surgical technique of Musset

Procedure: surgical technique of Musset; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire Short Form 36 (SF 36) (0 to 100)	Assessment of quality of life and overall satisfaction through validated questionnaire	Day 1
Questionnaire World Health Organization Quality of Life-Bref (WHOQOL-Bref) (0 to 100 in 4 fields)	Assessment of mental health through validated questionnaire	Day 1
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)	Assessment of sexual quality of life through validated questionnaire	Day 1
Questionnaire Sexual Activity Questionnaire (SAQ)	Assessment of sexual quality of life through validated questionnaire	Day 1
Cleveland Score (0 to 20)	Evaluation of the quality of the anatomical restitution through validated questionnaire	Day 1
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.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: surgical technique of Musset
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Vaginal Diseases; Intestinal Fistula; Digestive System Fistula; Rectal Fistula; Vaginal Fistula; Fistula; Rectovaginal Fistula
• Other Study ID Numbers: LONGOMUSSET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No