Clinical Trial: Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus

Brief Summary: The trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (Karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.

Detailed Summary:

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.


Sponsor: Umeå University

Current Primary Outcome: time to complete wound healing [ Time Frame: one year or until reoperation ]

Original Primary Outcome:

  • time to complete wound healing
  • postoperative wound infection rate
  • recurrence rate


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • health-related quality of life
  • time needed returning to normal physical activity after operation
  • days spent on sick-leave
  • health care costs and total costs including sick-leave


Information By: Umeå University

Dates:
Date Received: December 15, 2006
Date Started: March 2006
Date Completion:
Last Updated: May 31, 2016
Last Verified: May 2016