Pilonidal SinusNCT02663466
Off-midline Closure Errors as a Risk Factor for Recurrence Following Limberg Flap in Patients With Pilonidal Sinus
An observational study of Pilonidal Sinus and Recurrence, run by Medical Park Gaziantep Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background. Limberg flap, one of the recently being popularized off-midline closure techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however, recurrences still can be seen. Objective. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pilonidal Sinus, Recurrence
- What is being tested?
- erroneous off-midline closures
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Nov 2015
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with clinically confirmed recurrence of SPS following LF surgery (recurrent group, RG) and patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible.
Who may be able to join
- age older than 16 years
- patients had been undergone LF reconstruction for primary SPS with no recurrence at least within the last 5 years
- patients with a clinical diagnosis of disease recurrence following LF surgery performed for primary SPS
- patients or his/her legal representative giving informed consent to make interview and participate to the study.
Who cannot join
- age younger than 16 years
- patients had been undergone a surgery other than LF for primary SPS
- patients with clinical history of multiple recurrence of the disease after any surgical procedure
- patients who had a recurrence due to the reasons other than correct or erroneous off-midline closure
- patients who had diabetes mellitus, or using steroids, had skin disorders such as hydradenitis suppurativa, had previously received phenol treatment, and patients who refused to give informed consent and who is unavailable or denied to make an interview.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Importance of Erroneous Off-midline Closure as a Recurrence Factor in Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Sinus: a Multicenter, Matched-case-control Study
Background. Limberg flap, one of the recently being popularized off-midline closure techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however, recurrences still can be seen.
Objective. The aim of this study was to assess the relationship between recurrence and off-midline closure errors made in Limberg flap reconstructions.
Read more
Design. A multicenter, matched-case-control study was conducted in three participating centers in Turkey.
Settings. Each hospital's database was searched separately and all patients with and without recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were identified.
Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG) were included to the study.
Interventions Main outcome measures. According to the off-midline closure concept, LF reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct closures (type 4, 5 and 6). Then the two groups were analyzed.
Read the detailed description
Sacrococcygeal Pilonidal sinus (SPS) is a common disorder with estimated incidence of 1.1% in the community and 9% in soldiers. Pilonidal disease is a function of hair x force x vulnerability of the skin, the theory purposed by Karydakis in his article in 1992, and hair follicle obstruction and enlargement, assertion of Bascom are the most widely accepted explanation for etio-pathogenesis of the disease. It is such a disease that, there is still no clear consensus in regard to its gold-standard treatment modality, even though a lot of research and publications.
However, recently off-midline closure techniques has being popularized, by which the suture line is positioned off the midline to ensure minimal chance of recurrence. One of these techniques is the rhomboid, or Limberg, flap (LF) which is widely performed flap surgery for the treatment of SPS in Turkey. However, recurrences can be seen following wide excision and LF reconstruction; therefore, successful implementation of LF technique in the sacrococcygeal area requires well-known characteristics of the flap and problematic anatomy of the gluteal cleft.
There are many reports that favor Limberg flap over others. Although the authors also used to perform LF in patients with SPS with acceptable results until 2008, then they shifted their routine surgical preference to another off-midline closure technique for cosmetic reasons after this date. But increasingly more cases have administered to our institution due to the complications and recurrences after LF which performed elsewhere. Therefore the authors decided to investigate the technical reasons and risk factors of the problem to avoid complications and recurrence related to the incorrect flap design.
The authors first hypothesized that there are an association between erroneous off-midline closures and recurrence in patients underwent LF reconstruction for primary SPS. Then they designed a case-control study to test this hypothesis.
- Conditions
- Pilonidal Sinus, Recurrence
- Being tested
- erroneous off-midline closures
- Keywords
- pilonidal sinus, Limberg flap, off-midline closure concept, recurrence
- Medical subject headings
- Pilonidal Sinus, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erroneous off-midline closuresProcedure or surgery
Also called Rhomboid flap reconstruction
All patients with pilonidal sinus recurrent disease following Limberg flap reconstruction in the recurrent group were examined by the authors in each study center and high resolution close-up photos of the patients' sacrococcygeal area were taken. These photos were then sent to all authors to asses and reach a collective decision to classify the erroneous off-midline closure technique and precisely measuring the distance between the flap border and the midline in the cleft. Same evaluation method was applied to the patients in nonrecurrent group. Following the completion of the assessments, all digital data of the patients were permanently deleted.
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Group | Patients with clinically confirmed recurrence of sacrococcygeal pilonidal sinus following Limberg flap surgery were eligible (recurrent group, RG). They were evaluated for erroneous off-midline closures as an exposure variable. Receives: Procedure: erroneous off-midline closures | |
| Nonrecurrent Group | Patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible. They were evaluated for erroneous off-midline closures as an exposure variable. Receives: Procedure: erroneous off-midline closures |
What is being measured
The primary outcome is the main question the study is designed to answer.
erroneous off-midline closures
Erroneous off-midline closure referred to the incision lines and/or angles of the LF are centered in- and/or crossed the midline or to be closer than 1 cm to the midline of the cleft between the buttocks.
Measured: within 1 mont after last patient included to the study
Secondary outcomes (3)
Suture type
Suture type was referred to the LF skin suturing type. We classified suture types into two categories; i) intermittent type stitches with multifilament or monofilament sutures or with skin staplers, ii) continuous type which referred subcuticular stitch with a monofilament nonabsorbable suture.
Measured: within the first month after completion of the patient recruitment
Safe distance
Safe distance was referred the distance between the flap border and midline to be 1 cm or more.
Measured: within 1 month after the last patient included to the study
Correct off-midline closures
Proper off-midline closure referred to the incision lines and/or angles of the LF are not centered in- and/or not crossed the midline or to be farther than at least 1 centimeter to the midline of the cleft between the buttocks.
Measured: within 1 month after last patient included to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- Mehmet Kaplan, M.D., Study director, Bahcesehir University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663466
- Sponsor's protocol ID
- MK-005-PS
- Status last verified
- Jan 2016
- First submitted
- 18 Jan 2016
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Erroneous Off-midline Closure as a Recurrence Factor in Limberg Flap Reconstruction in Sacrococcygeal Pilonidal Sinus: a Multicenter, Matched-case-control Study
- ClinicalTrials.gov ID
- NCT02663466
- Acronym / sponsor ID
- MK-005-PS
- Conditions
- Pilonidal Sinus, Recurrence
- Keywords
- pilonidal sinus, Limberg flap, off-midline closure concept, recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medical Park Gaziantep HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Jan 2016 (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.
Background. Limberg flap, one of the recently being popularized off-midline closure techniques, is widely performed for the treatment of sacrococcygeal pilonidal sinus; however, recurrences still can be seen.
Objective. The aim of this study was to assess the relationship between recurrence and off-midline closure errors made in Limberg flap reconstructions.
Design. A multicenter, matched-case-control study was conducted in three participating centers in Turkey.
Settings. Each hospital's database was searched separately and all patients with and without recurrence who underwent LF surgery for primary SPS from January 2008 to July 2015 were identified.
Patients. Sixty patients with recurrent disease (recurrent group, RG) and 120 matched cases of recurrence-free patients for at least 5 years following surgery (non-recurrent group, NRG) were included to the study.
Interventions Main outcome measures. According to the off-midline closure concept, LF reconstructions were classified into incorrect closures (Type 1, 2 and 3) and correct closures (type 4, 5 and 6). Then the two groups were analyzed.
Detailed description
Sacrococcygeal Pilonidal sinus (SPS) is a common disorder with estimated incidence of 1.1% in the community and 9% in soldiers. Pilonidal disease is a function of hair x force x vulnerability of the skin, the theory purposed by Karydakis in his article in 1992, and hair follicle obstruction and enlargement, assertion of Bascom are the most widely accepted explanation for etio-pathogenesis of the disease. It is such a disease that, there is still no clear consensus in regard to its gold-standard treatment modality, even though a lot of research and publications.
However, recently off-midline closure techniques has being popularized, by which the suture line is positioned off the midline to ensure minimal chance of recurrence. One of these techniques is the rhomboid, or Limberg, flap (LF) which is widely performed flap surgery for the treatment of SPS in Turkey. However, recurrences can be seen following wide excision and LF reconstruction; therefore, successful implementation of LF technique in the sacrococcygeal area requires well-known characteristics of the flap and problematic anatomy of the gluteal cleft.
There are many reports that favor Limberg flap over others. Although the authors also used to perform LF in patients with SPS with acceptable results until 2008, then they shifted their routine surgical preference to another off-midline closure technique for cosmetic reasons after this date. But increasingly more cases have administered to our institution due to the complications and recurrences after LF which performed elsewhere. Therefore the authors decided to investigate the technical reasons and risk factors of the problem to avoid complications and recurrence related to the incorrect flap design.
The authors first hypothesized that there are an association between erroneous off-midline closures and recurrence in patients underwent LF reconstruction for primary SPS. Then they designed a case-control study to test this hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Group | – | Procedure: erroneous off-midline closuresPatients with clinically confirmed recurrence of sacrococcygeal pilonidal sinus following Limberg flap surgery were eligible (recurrent group, RG). They were evaluated for erroneous off-midline closures as an exposure variable. |
| Nonrecurrent Group | – | Procedure: erroneous off-midline closuresPatients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible. They were evaluated for erroneous off-midline closures as an exposure variable. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with clinically confirmed recurrence of SPS following LF surgery (recurrent group, RG) and patients who underwent same surgery from the January 2008 to July 2015 but have not had recurrence in the five-year follow-up period (non-recurrent group, NRG) were accepted eligible.
Key inclusion criteria (4 listed)
- age older than 16 years
- patients had been undergone LF reconstruction for primary SPS with no recurrence at least within the last 5 years
- patients with a clinical diagnosis of disease recurrence following LF surgery performed for primary SPS
- patients or his/her legal representative giving informed consent to make interview and participate to the study.
Key exclusion criteria (5 listed)
- age younger than 16 years
- patients had been undergone a surgery other than LF for primary SPS
- patients with clinical history of multiple recurrence of the disease after any surgical procedure
- patients who had a recurrence due to the reasons other than correct or erroneous off-midline closure
- patients who had diabetes mellitus, or using steroids, had skin disorders such as hydradenitis suppurativa, had previously received phenol treatment, and patients who refused to give informed consent and who is unavailable or denied to make an interview.
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 |
|---|---|---|
| erroneous off-midline closuresAlso: Rhomboid flap reconstructionAll patients with pilonidal sinus recurrent disease following Limberg flap reconstruction in the recurrent group were examined by the authors in each study center and high resolution close-up photos of the patients' sacrococcygeal area were taken. These photos were then sent to all authors to asses and reach a collective decision to classify the erroneous off-midline closure technique and precisely measuring the distance between the flap border and the midline in the cleft. Same evaluation method was applied to the patients in nonrecurrent group. Following the completion of the assessments, all digital data of the patients were permanently deleted. | Procedure or surgery | Nonrecurrent Group, Recurrent Group |
Primary outcome
erroneous off-midline closures
Time frame: within 1 mont after last patient included to the study
Erroneous off-midline closure referred to the incision lines and/or angles of the LF are centered in- and/or crossed the midline or to be closer than 1 cm to the midline of the cleft between the buttocks.
3 secondary outcomes
Suture type
Time frame: within the first month after completion of the patient recruitment
Safe distance
Time frame: within 1 month after the last patient included to the study
Correct off-midline closures
Time frame: within 1 month after last patient included to the study
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 26 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Mehmet Kaplan, M.D. study director
Bahcesehir University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus and Recurrence, run by Medical Park Gaziantep Hospital at 1 site in Turkey (Türkiye).
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 5 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 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
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?
erroneous off-midline closures (time frame: within 1 mont after last patient included to the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2016.