Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
1 other identifier
interventional
84
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2003
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedResults Posted
Study results publicly available
February 16, 2017
CompletedFebruary 16, 2017
December 1, 2016
6.5 years
August 8, 2012
January 18, 2016
December 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure Rate
Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.
2 year after initial treatment
Secondary Outcomes (2)
Healing Time
two year
Visual Analogue Scale for Patient Satisfaction (VAS-PS)
30 days
Other Outcomes (1)
Costs
two year
Study Arms (2)
Surgery
EXPERIMENTALCircular 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.
Conservative
ACTIVE COMPARATORConservative 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.
Interventions
this treatment will include conservative procedures under local anesthesia for patient comfort.
Eligibility Criteria
You may qualify if:
- all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hatem Hospital
Gaziantep, 27090, Turkey (Türkiye)
Medical Park Gaziantep Hospital
Gaziantep, 27090, Turkey (Türkiye)
25 Aralık Familiy Physician Health Center
Gaziantep, 27100, Turkey (Türkiye)
Dr.Ersin Arslan State Hospital
Gaziantep, 27100, Turkey (Türkiye)
Şehitkamil State Hospital
Gaziantep, 27100, Turkey (Türkiye)
Related Publications (1)
Kaplan 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: 27016906DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mehmet Kaplan
- Organization
- Bahcesehir University, School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet KAPLAN, MD
Medical Park Gaziantep Hospital, Gaziantep, Turkey
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 10, 2012
Study Start
November 1, 2003
Primary Completion
May 1, 2010
Study Completion
May 1, 2012
Last Updated
February 16, 2017
Results First Posted
February 16, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share