Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial (Published March 2022: https://doi.org/10.1093/bjsopen/zrac007)
KolorektalFelix Binnermark1, Christoffer Odensten3, Martin Rutegård1, 2, Karl A Franklin1, Markku Haapamäki1
1 Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden
2 Wallenberg Centre for Molecular Medicine, Umeå University, Umeå, Sweden
3 Department of Surgical and Perioperative Sciences, Surgery, Umeå University Educational Unit at Sunderby Hospital, Sunderby, Sweden
Introduktion/Introduction
There are several surgical options for the management of pilonidal disease, but prospective studies are rare. The study hypothesis was that Karydakis flap surgery would result in shorter wound healing and fewer recurrences than excision of pilonidal sinus and suture in the midline.
Metod/Method
A randomized clinical trial was conducted in two hospitals in Sweden between 2006 and 2015 to compare excision and suture in the midline with Karydakis flap surgery. Adult patients with a chronic pilonidal sinus disease were randomized 1:1 at the outpatient clinic without blinding. Participants were followed up until complete wound healing; late follow-up after 6–13 years was performed by telephone by two blinded assessors. The two co-primary outcomes were time to complete wound healing and recurrence rate.
Resultat/Result
The study was terminated early at a planned interim analysis due slow recruitment and a significant difference in primary outcome. In total, 125 patients were randomized, of whom 116 were available for the present analysis. Median wound healing time was 49 days (95 per cent confidence interval (c.i.) 32 to 66) for excision with suture in the midline and 14 days (95 per cent c.i. 12 to 20) for Karydakis flap surgery (P = 0.001). There were five recurrences in each group, after a median follow-up of 11 years (P = 0.753).
Diskussion/Discussion
Karydakis flap surgery for pilonidal sinus disease led to a shorter wound healing time than excision and suture in the midline but no difference in recurrence rates.
