SNFGE SNFGE
 
Thématique :
- Colo-proctologie
Originalité :
Intermédiaire
Solidité :
Très solide
Doit faire évoluer notre pratique :
Immédiatement
 
 
Nom du veilleur :
Docteur Vincent de PARADES
Coup de coeur :
 
 
British Journal of Surgery
  2017/05  
 
  2017 May.  
  doi: 10.1002/bjs.10549.  
 
  Randomized clinical trial comparing collagen plug and advancement flap for trans-sphincteric anal fistula  
 
  Bondi J, Avdagic J, Karlbom U, Hallböök O, Kalman D, Šaltytė Benth J, Naimy N, Øresland T  
  https://www.ncbi.nlm.nih.gov/pubmed/28489253  
 
 

Abstract

BACKGROUND:

The role of a collagen plug for treating anal fistula is not well established. A randomized prospective multicentre non-inferiority study of surgical treatment of trans-sphincteric cryptogenic fistulas was undertaken, comparing the anal fistula plug with the mucosal advancement flap with regard to fistula recurrence rate and functional outcome.

METHODS:

Patients with an anal fistula were evaluated for eligibility in three centres, and randomized to either mucosal advancement flap surgery or collagen plug, with clinical follow-up at 3 and 12 months. The primary outcome was the fistula recurrence rate. Anal pain (visual analogue scale), anal incontinence (St Mark's score) and quality of life (Short Form 36 questionnaire) were also reported.

RESULTS:

Ninety-four patients were included; 48 were allocated to the plug procedure and 46 to advancement flap surgery. The median follow-up was 12 (range 9-24) months. The recurrence rate at 12 months was 66 per cent (27 of 41 patients) in the plug group and 38 per cent (15 of 40) in the flap group (P = 0·006). Anal pain was reduced after operation in both groups. Anal incontinence did not change in the follow-up period. Patients reported an increased quality of life after 3 months. There were no differences between the groups with regard to pain, incontinence or quality of life.

CONCLUSION:

There was a considerably higher recurrence rate after the anal fistula plug procedure than following advancement flap repair. Registration number: NCT01021774 (http://www.clinicaltrials.gov).

 
 
Question posée
 
Comparer la mise en place d’un plug au lambeau d’avancement dans le traitement des fistules anales.
 
Question posée
 
Le lambeau d’avancement est la technique la plus efficace avec un taux significativement supérieur de guérison (62 versus 34 %) après 12 mois de suivi médian.
 
Commentaires

Le plug est un dispositif médical qui n’a pas réussi à faire son « trou » sur le marché français du traitement des fistules anales.
Il faut dire que les résultats modestes de la littérature incitent à la prudence et cet essai contrôlé randomisé risque fort de sonner encore davantage le glas de ce matériel par ailleurs coûteux…

 
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