Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05079139 |
| Other study ID # |
LONGOMUSSET |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
March 24, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Centre Hospitalier Intercommunal Creteil |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 anatomical results at a
distance from the procedure.
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.
