Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial

J Am Coll Surg. 2016 May;222(5):878-89. doi: 10.1016/j.jamcollsurg.2016.01.056. Epub 2016 Feb 23.

Abstract

Background: Umbilical pilonidal sinus (UPS) is one of the most neglected disorders, and there is still no clear consensus regarding optimal treatment of the disease. We therefore present our data from a prospective, randomized, controlled clinical trial comparing conservative vs surgical treatment of UPS.

Study design: The study was conducted in Turkey between January 2012 and November 2015. All eligible patients with the diagnosis of UPS (n = 84) were randomized for either conservative treatment (CT, n = 42) or surgical treatment (ST, n = 42). All patients were followed up for at least 2 years; then, the results of both groups were compared. The primary outcomes were initial healing, recurrence, and the cure rate of the disease after each treatment modality.

Results: Mean (± SD) age of the patients was 20.83 ± 5.73 years old, and the majority were men (94%). Nearly 60% of the patients had a deep navel, and 55% had intense hair status. The main symptoms were drainage and wetness, pain, itching, and malodor. Overall, in 10 (27.8%) patients, relapse of the disease was observed in the CT group; it was observed in only 1 patient in the ST group (p = 0.002). Initial healing time was significantly shorter in the ST group (p = 0.001). Of the 81 patients who completed the 2-year follow-up, a cure could be obtained in only 28 of 41 patients in the CT group; it was achieved in all 40 patients in the ST group (68.3% vs 100%, respectively; p = 0.0001).

Conclusions: This study provided evidence that surgical treatment is superior to conservative surgery regarding the primary and secondary outcomes of UPS at least 2 years after surgery.

Trial registration: ClinicalTrials.gov NCT01662765.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Conservative Treatment / methods*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Pilonidal Sinus / surgery*
  • Prospective Studies
  • Surgical Procedures, Operative / methods*
  • Umbilicus / surgery*
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01662765