Clinical trial NCT00412659: Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus
Official title: An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pilonidal Sinus
Keywords: Sinus, Pilonidal
Pilonidal sinus
Pilonidal cysts
Pilonidal disease
midline excision
Karydakis operation
expertise based study
surgery
therapy
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: County Council of Norrbotten, Sweden
name: Norrlandstingens Regionförbund
First posted: 2006-12-18
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: time to complete wound healing
timeFrame: one year or until reoperation
Secondary outcomes:
measure: health-related quality of life
timeFrame: one year
measure: time needed returning to normal physical activity after operation
timeFrame: one year or until reoperation
measure: days spent on sick-leave
timeFrame: one year or until reoperation
measure: health care costs and total costs
timeFrame: one year
measure: postoperative wound infection rate
timeFrame: one year or until reoperation
measure: recurrence rate
timeFrame: one year or until reoperation
Other outcomes:
Locations:
city: Luleå
country: Sweden
facility: Sunderby Regional Hospital
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: County Council of Norrbotten, Sweden
name: Christoffer Odensten, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Markku M Haapamaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Peter Naredi, MD, Ph D
role: STUDY_CHAIR
affiliation: County Council of Norrbotten
name: Michael Dahlberg, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.