Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
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ClinicalTrials.gov Identifier: NCT01662765 |
Recruitment Status :
Completed
First Posted : August 10, 2012
Results First Posted : February 16, 2017
Last Update Posted : February 16, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | August 8, 2012 | |||
First Posted Date ICMJE | August 10, 2012 | |||
Results First Submitted Date ICMJE | January 18, 2016 | |||
Results First Posted Date ICMJE | February 16, 2017 | |||
Last Update Posted Date | February 16, 2017 | |||
Study Start Date ICMJE | November 2003 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Cure Rate [ Time Frame: 2 year after initial treatment ] 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.
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Original Primary Outcome Measures ICMJE |
Cure Rate [ Time Frame: 2 year after initial treatment ] Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. In contrast, a 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.
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Change History | Complete list of historical versions of study NCT01662765 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Costs [ Time Frame: two year ] from initial treatment to the complete healing, all kind of cost will be calculated.
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Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease | |||
Official Title ICMJE | Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial | |||
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. | |||
Detailed Description | Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options. UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus. Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others. A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS. This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
84 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2012 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Turkey | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01662765 | |||
Other Study ID Numbers ICMJE | MK-003-UPS | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Mehmet Kaplan, Medical Park Gaziantep Hospital | |||
Study Sponsor ICMJE | Medical Park Gaziantep Hospital | |||
Collaborators ICMJE | Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti. | |||
Investigators ICMJE |
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PRS Account | Medical Park Gaziantep Hospital | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |