Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus

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

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.

Study Overview

• Status: Completed
• Conditions: Pilonidal Sinus
• Intervention / Treatment: Procedure: Surgery for pilonidal disease, midline excision; Procedure: Surgery for pilonidal disease, Karydakis operation

Detailed Description

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
• Enrollment (Actual): 125
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Luleå, Sweden, SE 972 80
    • Sunderby Regional Hospital
  • Umeå, Sweden, SE 90185
    • Umea University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older.
• Surgery is considered the best available treatment.
• The patient understands trial information and is capable of making a decision for informed consent after having received information.
• The patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial.

Exclusion Criteria:

• Patient has had a pilonidal abscess during the last four weeks before the planned day of surgery
• Patient has had surgery (excision) for pilonidal sinus more than once before.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time to complete wound healing	one year or until reoperation

Secondary Outcome Measures

Outcome Measure	Time Frame
health-related quality of life	one year
time needed returning to normal physical activity after operation	one year or until reoperation
days spent on sick-leave	one year or until reoperation
health care costs and total costs	one year
postoperative wound infection rate	one year or until reoperation
recurrence rate	one year or until reoperation

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: County Council of Norrbotten, Sweden; Norrlandstingens Regionförbund
• Investigators: Principal Investigator: Christoffer Odensten, MD, County Council of Norrbotten, Sweden; Study Chair: Peter Naredi, MD, Ph D, Umeå University; Study Director: Michael Dahlberg, MD, PhD, County Council of Norrbotten

Publications and helpful links

General Publications

• Karydakis GE. New approach to the problem of pilonidal sinus. Lancet. 1973 Dec 22;2(7843):1414-5. doi: 10.1016/s0140-6736(73)92803-1. No abstract available.
• Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, Schunemann HJ, Norman GR, Guyatt GH. Need for expertise based randomised controlled trials. BMJ. 2005 Jan 8;330(7482):88. doi: 10.1136/bmj.330.7482.88.
• Petersen S, Koch R, Stelzner S, Wendlandt TP, Ludwig K. Primary closure techniques in chronic pilonidal sinus: a survey of the results of different surgical approaches. Dis Colon Rectum. 2002 Nov;45(11):1458-67. doi: 10.1007/s10350-004-6451-2.
• Dalenback J, Magnusson O, Wedel N, Rimback G. Prospective follow-up after ambulatory plain midline excision of pilonidal sinus and primary suture under local anaesthesia--efficient, sufficient, and persistent. Colorectal Dis. 2004 Nov;6(6):488-93. doi: 10.1111/j.1463-1318.2004.00693.x.
• Hemmingsson O, Binnermark F, Odensten C, Rutegard M, Franklin KA, Haapamaki MM. Excision and suture in the midline versus Karydakis flap surgery for pilonidal sinus: randomized clinical trial. BJS Open. 2022 Mar 8;6(2):zrac007. doi: 10.1093/bjsopen/zrac007.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): March 1, 2016

Study Registration Dates

• First Submitted: December 15, 2006
• First Submitted That Met QC Criteria: December 15, 2006
• First Posted (ESTIMATE): December 18, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 31, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: surgery; therapy; Pilonidal disease; Pilonidal sinus; Sinus, Pilonidal; Pilonidal cysts; midline excision; Karydakis operation; expertise based study
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: PSIN-05-178M