Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus
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|ClinicalTrials.gov Identifier: NCT00412659|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pilonidal Sinus||Procedure: Surgery for pilonidal disease, midline excision Procedure: Surgery for pilonidal disease, Karydakis operation||Phase 2 Phase 3|
Excision in the midline and primary suture is a long proven method of treating pilonidal sinus. However it's associated with high incidence of post operative infection and recurrence. On the other hand Karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. The purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. In addition the investigators aim to compare the quality of life at defined time points after surgery. Eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the Karydakis operation (expertise based design). The design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached.
Comparison: Midline excision andd primary suture compared with the Karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: Midline excision
Midline excision for pilonidal sinus disease.
Procedure: Surgery for pilonidal disease, midline excision
A midline excision is made for the treatment of pilonidal sinus disease.
Active Comparator: Karydakis
Karydakis operation for pilonidal sinus disease.
Procedure: Surgery for pilonidal disease, Karydakis operation
A Karydakis operation is done for the treatment of pilonidal sinus disease.
- time to complete wound healing [ Time Frame: one year or until reoperation ]
- health-related quality of life [ Time Frame: one year ]
- time needed returning to normal physical activity after operation [ Time Frame: one year or until reoperation ]
- days spent on sick-leave [ Time Frame: one year or until reoperation ]
- health care costs and total costs [ Time Frame: one year ]
- postoperative wound infection rate [ Time Frame: one year or until reoperation ]
- recurrence rate [ Time Frame: one year or until reoperation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412659
|Sunderby Regional Hospital|
|Luleå, Sweden, SE 972 80|
|Umeå University Hospital|
|Umeå, Sweden, SE 90185|
|Principal Investigator:||Christoffer Odensten, MD||County Council of Norrbotten, Sweden|
|Principal Investigator:||Markku M Haapamaki, MD, PhD||Umeå University|
|Study Chair:||Peter Naredi, MD, Ph D||Umeå University|
|Study Director:||Michael Dahlberg, MD, PhD||County Council of Norrbotten|