NCT00412659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

10 years

First QC Date

December 15, 2006

Last Update Submit

May 31, 2016

Conditions

Pilonidal Sinus

Keywords

Sinus, PilonidalPilonidal sinusPilonidal cystsPilonidal diseasemidline excisionKarydakis operationexpertise based studysurgerytherapy

Outcome Measures

Primary Outcomes (1)

  • time to complete wound healing

    one year or until reoperation

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Midline excision

ACTIVE COMPARATOR

Midline excision for pilonidal sinus disease.

Procedure: Surgery for pilonidal disease, midline excision

Karydakis

ACTIVE COMPARATOR

Karydakis operation for pilonidal sinus disease.

Procedure: Surgery for pilonidal disease, Karydakis operation

Interventions

Surgery for pilonidal disease, midline excisionPROCEDURE

A midline excision is made for the treatment of pilonidal sinus disease.

Midline excision
Surgery for pilonidal disease, Karydakis operationPROCEDURE

A Karydakis operation is done for the treatment of pilonidal sinus disease.

Karydakis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunderby Regional Hospital

Luleå, SE 972 80, Sweden

Location

Umeå University Hospital

Umeå, SE 90185, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 15637373BACKGROUND

  • 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.

    PMID: 12432292BACKGROUND

  • 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.

    PMID: 4128725BACKGROUND

  • 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.

    PMID: 15521941BACKGROUND

  • 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.

    PMID: 35289848DERIVED

MeSH Terms

Conditions

Pilonidal Sinus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Christoffer Odensten, MD

    County Council of Norrbotten, Sweden

    PRINCIPAL INVESTIGATOR

  • Markku M Haapamaki, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

  • Peter Naredi, MD, Ph D

    Umeå University

    STUDY CHAIR

  • Michael Dahlberg, MD, PhD

    County Council of Norrbotten

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, PhD

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

SE(2)