Clinical trial · Interventional
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Sinus | — | UNRESOLVED | — |
| Sinus; Dermal, Pilonidal | — | UNRESOLVED | — |
| Umbilical Granuloma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conservative | Other | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Surgery
- description
- Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium. Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.
- interventionNames
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Conservative
- description
- Conservative treatment described as follow: Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus. postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKaplan M, Ozcan O, Kaplan FC, Yalcin HC, Salman B. 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. PMID 27016906