Abstract
Purpose
Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC).
Methods
This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up.
Results
After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23–328) days in the S group compared to 34 (13–141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar.
Conclusions
PC leads to faster healing compared to S, with similar healthcare burden.
Trial Registration
The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996).
The study was carried out at the Regional Hospital of Lugano, Switzerland
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Change history
26 May 2020
The original version of this article, unfortunately, contained an error. The given names and family names of the authors were interchanged and are now presented correctly. The original article has been corrected.]
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Acknowledgments
We kindly thank Prof. Pietro Majno-Hürst for his critical review of the manuscript and Dr. Luca Fumagalli for the surgical technique illustrations.
Funding
The study was funded by the peer reviewed competitive fund ABREOC (Advisory Board for Research of the Ente Ospedaliero Cantonale).
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The original version of this article was revised: The given names and family names of the authors were interchanged and are now presented correctly.
Article Summary
We randomized patients with chronic pilonidal sinus to sinusectomy or excision and paramedian primary closure. The importance of this study is that it showed faster healing times in the paramedian primary closure group with no difference in recurrence rates or “healthcare burden”.
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Popeskou, S.G., Pravini, B., Panteleimonitis, S. et al. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis 35, 1193–1199 (2020). https://doi.org/10.1007/s00384-020-03551-9
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DOI: https://doi.org/10.1007/s00384-020-03551-9