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Randomized Controlled Trial
. 2022 Mar 8;6(2):zrac007.
doi: 10.1093/bjsopen/zrac007.

Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial

Oskar Hemmingsson  1   2 , Felix Binnermark  1 , Christoffer Odensten  3 , Martin Rutegård  1   2 , Karl A Franklin  1 , Markku M Haapamäki  1
Affiliations
Randomized Controlled Trial

Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial

Oskar Hemmingsson et al. BJS Open. .

Abstract

Background: There are several surgical options for the management of pilonidal disease, including midline and off midline closure, 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.

Methods: 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. Power calculation based on recurrence of 2 per cent for Karydakis flap and 10 per cent for excision and primary closure in the midline required 400 patients with 90 per cent statistical power at 5 per cent significance assuming 10 per cent loss during follow-up. 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.

Results: 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).

Conclusion: 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.Registration number: NCT00412659 (http://www.clinicaltrials.gov).

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Figures

Fig. 1
Fig. 1
Skin incision in Karydakis flap surgery is marked with a black line on the photograph
Fig. 2
Fig. 2
Relevant anatomy, line of excision, creation of flap and sutures in Karydakis flap surgery
Fig. 3
Fig. 3
CONSORT diagram of study patients
Fig. 4
Fig. 4
Kaplan–Meier graph illustrating time to complete wound healing for the two study groups
Fig. 5
Fig. 5
Kaplan–Meier graph illustrating the proportion of patients with recurrence registered by time
See this image and copyright information in PMC

Comment in

References

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