Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial - 25/04/16
, Onder Ozcan, MD b, Fatma Cigdem Kaplan, MD e, Huseyin Cahit Yalcin, MD c, Bulent Salman, MD, FACS dAbstract |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations and Acronyms : CT, OSAS, PSAS, ST, UPS, VAS-PS
Plan
| Disclosure Information: Nothing to disclose. |
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| This study is registered at ClinicalTrials.gov with number NCT01662765, and the name of the trial is registered as “Conservative vs surgical treatment of umbilical pilonidal disease.” Full details of the trial protocol can be accessed at: NCT01662765. |
Vol 222 - N° 5
P. 878-889 - mai 2016 Retour au numéro
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