N/A
Completed N=84
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
Pilonidal Sinus · Sinus; Dermal, Pilonidal · Umbilical Granuloma
Source: ClinicalTrials.gov NCT01662765 ↗
Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Cure Rate — 28; 40 participants
Summary
The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate |
28; 40 | — |
| SECONDARY Healing Time |
12.81; 17.06 | — |
| SECONDARY Visual Analogue Scale for Patient Satisfaction (VAS-PS) |
66; 71 | — |
Eligibility Criteria
Inclusion Criteria
- all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
Exclusion Criteria
- no informed consent
- serious coagulation abnormalities
- known allergy to local anesthetics
- pregnancy, or women who refused contraception at the time of treatment
- other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid cyst
- the patients who diagnosed with urachal and omphalomesenteric anomalies through radiological investigation
- patients who underwent umbilical operation
Data sourced from ClinicalTrials.gov (NCT01662765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.