Short-term outcomes of the over-the-scope clip proctology system for rectovaginal fistula repair: a prospective study.
OTSC proctology system
Rectovaginal fistula
Surgery
Journal
Techniques in coloproctology
ISSN: 1128-045X
Titre abrégé: Tech Coloproctol
Pays: Italy
ID NLM: 9613614
Informations de publication
Date de publication:
Mar 2019
Mar 2019
Historique:
received:
30
09
2018
accepted:
13
02
2019
pubmed:
3
4
2019
medline:
9
1
2020
entrez:
3
4
2019
Statut:
ppublish
Résumé
The over-the-scope clip proctology system is rather new and information regarding its use for the closure of anorectal fistulas is scarce. No study has been designed to focus exclusively on its application in the treatment of rectovaginal fistulas. The aim of the study was to evaluate the feasibility, safety, and effectiveness of the clip for rectovaginal fistula repair. From September 2014 to November 2017, consecutive patients underwent a rectovaginal fistula repair using the over-the-scope clip proctology system and were enrolled in a non-randomized prospective monocentric study. The primary outcome was fistula healing at 8 months. Secondary outcomes included assessment of morbidity and timing of rectovaginal fistula recurrence. There were 16 patients with a median age of 40.1 years. The most common causes of rectovaginal fistula were adverse events following proctectomy or pelvic radiotherapy (6 patients), obstetric trauma (5 patients) and inflammatory bowel disease (3 patients). Most participants had undergone at least two previous surgical interventions before the clipping procedure. 11 patients had a temporary diverting stoma at time of the clipping procedure. Successful primary healing of the fistula was observed in 7 (43.7%) patients. Short-term complications were rare and included pain, which occurred in 4 patients, and spontaneous clip detachment, which occurred in 2 patients. Most recurrences appeared shortly after the procedure, with a median delay of 45 days (range 16-217). We demonstrated the feasibility, safety, and reproducibility of the Over-The-Scope Clip Proctology system in rectovaginal fistula repair for the patients selected. Further trials should be designed, incorporating comparisons to well-established techniques, a longer follow-up period, and a larger cohort.
Sections du résumé
BACKGROUND
BACKGROUND
The over-the-scope clip proctology system is rather new and information regarding its use for the closure of anorectal fistulas is scarce. No study has been designed to focus exclusively on its application in the treatment of rectovaginal fistulas. The aim of the study was to evaluate the feasibility, safety, and effectiveness of the clip for rectovaginal fistula repair.
METHODS
METHODS
From September 2014 to November 2017, consecutive patients underwent a rectovaginal fistula repair using the over-the-scope clip proctology system and were enrolled in a non-randomized prospective monocentric study. The primary outcome was fistula healing at 8 months. Secondary outcomes included assessment of morbidity and timing of rectovaginal fistula recurrence.
RESULTS
RESULTS
There were 16 patients with a median age of 40.1 years. The most common causes of rectovaginal fistula were adverse events following proctectomy or pelvic radiotherapy (6 patients), obstetric trauma (5 patients) and inflammatory bowel disease (3 patients). Most participants had undergone at least two previous surgical interventions before the clipping procedure. 11 patients had a temporary diverting stoma at time of the clipping procedure. Successful primary healing of the fistula was observed in 7 (43.7%) patients. Short-term complications were rare and included pain, which occurred in 4 patients, and spontaneous clip detachment, which occurred in 2 patients. Most recurrences appeared shortly after the procedure, with a median delay of 45 days (range 16-217).
CONCLUSIONS
CONCLUSIONS
We demonstrated the feasibility, safety, and reproducibility of the Over-The-Scope Clip Proctology system in rectovaginal fistula repair for the patients selected. Further trials should be designed, incorporating comparisons to well-established techniques, a longer follow-up period, and a larger cohort.
Identifiants
pubmed: 30937645
doi: 10.1007/s10151-019-01948-5
pii: 10.1007/s10151-019-01948-5
doi:
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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