Rectovaginal FistulaLONGOMUSSETNCT05079139
Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)
A study testing surgical technique of Musset in people with Rectovaginal Fistula and Obstetric Complication, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Rectovaginal Fistula, Obstetric Complication
- What is being tested?
- surgical technique of Musset
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2022to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rectovaginal Fistula, Obstetric Complication
- Being tested
- surgical technique of Musset
- Keywords
- surgical technique of Musset
- Medical subject headings
- Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical technique of MussetProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| surgical technique of Musset | Other | Not described Receives: Procedure: surgical technique of Musset |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (6)
Questionnaire Short Form 36 (SF 36) (0 to 100)
Assessment of quality of life and overall satisfaction through validated questionnaire
Measured: 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
Measured: Day 1
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)
Assessment of sexual quality of life through validated questionnaire
Measured: Day 1
Questionnaire Sexual Activity Questionnaire (SAQ)
Assessment of sexual quality of life through validated questionnaire
Measured: Day 1
Cleveland Score (0 to 20)
Evaluation of the quality of the anatomical restitution through validated questionnaire
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start20 Jan 2022
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectovaginal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079139
- Sponsor's protocol ID
- LONGOMUSSET
- Acronym
- LONGOMUSSET
- Status last verified
- Jan 2023
- First submitted
- 5 Oct 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)
- ClinicalTrials.gov ID
- NCT05079139
- Acronym / sponsor ID
- LONGOMUSSET / LONGOMUSSET
- Conditions
- Rectovaginal Fistula, Obstetric Complication
- Keywords
- surgical technique of Musset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive study
| Arm | Type | Receives |
|---|---|---|
| surgical technique of Musset | Other | Procedure: surgical technique of Musset |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical technique of MussetThe 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. | Procedure or surgery | surgical technique of Musset |
Primary outcome
Presence of gas and/or stool incontinence more than 6 months after surgery
Time frame: Day 1
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
6 secondary outcomes
Questionnaire Short Form 36 (SF 36) (0 to 100)
Time frame: Day 1
Questionnaire World Health Organization Quality of Life-Bref (WHOQOL-Bref) (0 to 100 in 4 fields)
Time frame: Day 1
Questionnaire Female Sexual Function Index (FSFI) (2 to 36)
Time frame: Day 1
Questionnaire Sexual Activity Questionnaire (SAQ)
Time frame: Day 1
Cleveland Score (0 to 20)
Time frame: Day 1
Patient Global Impression and Improvement (PGI-I) (1 to 7)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical technique of Musset in people with Rectovaginal Fistula and Obstetric Complication, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of gas and/or stool incontinence more than 6 months after surgery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.