Pilonidal SinusPhase 2/3NCT00412659
Mid-line Excision Versus Karydakis Operation for Pilonidal Sinus
A Phase 2/3 study testing Surgery for pilonidal disease, midline excision and Surgery for pilonidal disease, Karydakis operation in people with Pilonidal Sinus, run by Umeå University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Surgery for pilonidal disease, midline excision and Surgery for pilonidal disease, Karydakis operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesSweden
- Study dates
- Mar 2006to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sunderby Regional Hospital
Luleå, SE 972 80
Umeå University Hospital
Umeå, SE 90185
About this study
Official title: 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.
Read the 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.
- Conditions
- Pilonidal Sinus
- Being tested
- Surgery for pilonidal disease, midline excision, Surgery for pilonidal disease, Karydakis operation
- Keywords
- Sinus, Pilonidal, Pilonidal sinus, Pilonidal cysts, Pilonidal disease, midline excision, Karydakis operation, expertise based study, surgery, therapy
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for pilonidal disease, midline excisionProcedure or surgery
A midline excision is made for the treatment of pilonidal sinus disease.
Surgery for pilonidal disease, Karydakis operationProcedure or surgery
A Karydakis operation is done for the treatment of pilonidal sinus disease.
| Study group | Role | What they receive |
|---|---|---|
| Midline excision | Active comparator | Midline excision for pilonidal sinus disease. Receives: Procedure: Surgery for pilonidal disease, midline excision |
| Karydakis | Active comparator | Karydakis operation for pilonidal sinus disease. Receives: Procedure: Surgery for pilonidal disease, Karydakis operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to complete wound healing
Measured: one year or until reoperation
Secondary outcomes (6)
health-related quality of life
Measured: one year
time needed returning to normal physical activity after operation
Measured: one year or until reoperation
days spent on sick-leave
Measured: one year or until reoperation
health care costs and total costs
Measured: one year
postoperative wound infection rate
Measured: one year or until reoperation
recurrence rate
Measured: one year or until reoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden, Norrlandstingens Regionförbund
- Responsible party
- Principal investigator, Markku Haapamaki, Umeå University
- Investigators
- Christoffer Odensten, MD, Principal investigator, County Council of Norrbotten, SwedenMarkku M Haapamaki, MD, PhD, Principal investigator, Umeå UniversityPeter Naredi, MD, Ph D, Study chair, Umeå UniversityMichael Dahlberg, MD, PhD, Study director, County Council of Norrbotten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412659
- Sponsor's protocol ID
- PSIN-05-178M
- Status last verified
- May 2016
- First submitted
- 15 Dec 2006
- Last updated
- 1 Jun 2016
- Results posted
- No
Publications
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.
PubMed 15637373Petersen 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.
PubMed 12432292Karydakis 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.
PubMed 4128725Dalenback 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.
PubMed 15521941Hemmingsson 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.
PubMed 35289848
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expertise-based Randomized Controlled Trial Comparing Midline Excision Versus Karydakis Operation at Surgery for Pilonidal Sinus
- ClinicalTrials.gov ID
- NCT00412659
- Acronym / sponsor ID
- PSIN-05-178M
- Conditions
- Pilonidal Sinus
- Keywords
- Sinus, Pilonidal, Pilonidal sinus, Pilonidal cysts, Pilonidal disease, midline excision, Karydakis operation, expertise based study, surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- County Council of Norrbotten, Sweden, Norrlandstingens Regionförbund
- Study start
- Mar 2006
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midline excision | Active comparator | Procedure: Surgery for pilonidal disease, midline excisionMidline excision for pilonidal sinus disease. |
| Karydakis | Active comparator | Procedure: Surgery for pilonidal disease, Karydakis operationKarydakis operation for pilonidal sinus disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for pilonidal disease, midline excisionA midline excision is made for the treatment of pilonidal sinus disease. | Procedure or surgery | Midline excision |
| Surgery for pilonidal disease, Karydakis operationA Karydakis operation is done for the treatment of pilonidal sinus disease. | Procedure or surgery | Karydakis |
Primary outcome
time to complete wound healing
Time frame: one year or until reoperation
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Background: PubMed 15637373Devereaux 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.
- Background: PubMed 12432292Petersen 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.
- Background: PubMed 4128725Karydakis 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.
- Background: PubMed 15521941Dalenback 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.
- Derived from this study: PubMed 35289848Hemmingsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Odensten, MD principal investigator
County Council of Norrbotten, Sweden
Markku M Haapamaki, MD, PhD principal investigator
Umeå University
Peter Naredi, MD, Ph D study chair
Umeå University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Surgery for pilonidal disease, midline excision and Surgery for pilonidal disease, Karydakis operation in people with Pilonidal Sinus, run by Umeå University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to complete wound healing (time frame: one year or until reoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412659, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.