Pilonidal SinusNCT02849197
Study on Surgical Treatment of Pilonidal Sinus Disease
An observational study of Pilonidal Sinus, run by Bezmialem Vakif University.
Trial summary
Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon, in terms of postoperative outcomes and recurrence rates. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- surgery for pilonidal sinus disease
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 802 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 1082 patients who were diagnosed with pilonidal sinüs disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015.
Who may be able to join
- patients who were diagnosed with pilonidal sinus disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015
Who cannot join
- patients with incomplete personal and medical data and who could not be contacted by direct interview or by telephone
About this study
Official title: Comparative Analysis of the Same technique-the Same Surgeon Approach in the Surgical Treatment of Pilonidal Sinus Disease: A Retrospective Cohort Study
Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon, in terms of postoperative outcomes and recurrence rates.
Read the detailed description
Pilonidal sinus disease (PSD) is a common chronic disease that generally affects young adults below the age of 45. It is most commonly observed at the inter-gluteal region, though it may also affect other sites like the umbilicus and the inter-digital area, particularly among in barbers. The disease was long thought to be either congenital or acquired; although in recent years it has been more widely viewed as an acquired disease. The etiology of PSD is not fully understood, however, the most important cause is believed to be fallen hairs accumulating within skin folds and implanting within the skin. The skin becomes more prone to maceration, sweating and bacterial contamination, which facilitates implantation of fallen hairs, creating the necessary conditions for development of the disease. Although PSD is a benign disease, it produces symptoms such as pain and discharge, which adversely affect patient quality of life.
There are many approaches for treatment of the disease, including several surgical methods such as limited or large excision, primary closure, or flap techniques, and many other non-surgical methods. However, no consensus has been reached regarding the ideal treatment method. An ideal surgical treatment reduces recurrence and complication rates, and allows for minimal hospitalization and rapid return to daily activities. Among patients treated using the limited excision and primary closure method, the presence of a natal cleft is associated with higher morbidity, resulting in recurrence rates of 7-42%. For techniques that use the flap approach, this rate decreases to 0-3%. In patients undergoing the Rhomboid excision and Limberg flap techniques, which require a larger surgical area compared to the limited excision and primary closure methods, complication rates are lower, and length of hospital-stay and time to return to work are reduced. However, using the classical Limberg flap technique, maceration and scar formation due to sutures in the inter-gluteal sulcus, and the accumulation of hair at the midline may result in recurrence. Application of a modified Limberg technique that includes lateralization of the middle line can help reduce wound complications and recurrence rates. Several publications report contradicting results regarding surgical outcomes using the same technique, which may be attributable to differences in practice between surgeons. Therefore, it can be logical to explore the superiority of any type of surgical technique performed by the same surgeon for the surgical treatment of pilonidal sinus disease.
- Conditions
- Pilonidal Sinus
- Being tested
- surgery for pilonidal sinus disease
- Keywords
- pilonidal sinus, complication, 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.
surgery for pilonidal sinus diseaseProcedure or surgery
surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure | Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease.
Technique: primary closure. Technical details: An elliptical incision was made, and the excision included sinus openings at the median line and extended down to the pre-sacral fascia. One suction drain was placed in the wound cavity. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and skin was closed with interrupted 2-0 silk suture. Receives: Procedure: surgery for pilonidal sinus disease | |
| Limberg Flap Technique | Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease.
Technique: Limberg Flap Technique. Technical details: A rhomboid incision was made as to include all sinus openings, and an excision was made down to the pre-sacral fascia. A bisector drawn in the rhombohedron was extended laterally to a length similar to that of a corner of the rhombohedron. Then, the flap was prepared by removing gluteal muscle with its fascia. One suction drain was placed at the wound cavity. The base of the flap was approximated with the presacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable sutures, and the skin was closed with interrupted 3-0 prolene suture. Receives: Procedure: surgery for pilonidal sinus disease | |
| Modified Limberg Technique | Patients with pilonidal sinus disease treated with surgery for pilonidal sinus disease.
Technique: Modified Limberg Flap Technique. Technical details: As in Limberg flap technique, a rhomboid incision was made. Upper and lower corners of the excision were lateralized 2 cm away from the midline in order to keep the suturing line at the inferior from overlapping the midline. An excision was made down to the pre-sacral fascia. One suction drain was placed at the wound cavity, and the base of the flap was approximated with the pre-sacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and the skin was closed with 3-0 prolene. Receives: Procedure: surgery for pilonidal sinus disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: through study completion at an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJan 2011
- Primary completionJun 2015
- Study completionApr 2016
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.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hasbahceci, Bezmialem Vakif University
- Investigators
- mustafa hasbahceci, assoc. prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849197
- Sponsor's protocol ID
- PilonidalSinus-EK/MH
- Status last verified
- Jul 2016
- First submitted
- 20 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Same technique-the Same Surgeon Approach in the Surgical Treatment of Pilonidal Sinus Disease: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT02849197
- Acronym / sponsor ID
- PilonidalSinus-EK/MH
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal sinus, complication, recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Jul 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.
Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon, in terms of postoperative outcomes and recurrence rates.
Detailed description
Pilonidal sinus disease (PSD) is a common chronic disease that generally affects young adults below the age of 45. It is most commonly observed at the inter-gluteal region, though it may also affect other sites like the umbilicus and the inter-digital area, particularly among in barbers. The disease was long thought to be either congenital or acquired; although in recent years it has been more widely viewed as an acquired disease. The etiology of PSD is not fully understood, however, the most important cause is believed to be fallen hairs accumulating within skin folds and implanting within the skin. The skin becomes more prone to maceration, sweating and bacterial contamination, which facilitates implantation of fallen hairs, creating the necessary conditions for development of the disease. Although PSD is a benign disease, it produces symptoms such as pain and discharge, which adversely affect patient quality of life.
There are many approaches for treatment of the disease, including several surgical methods such as limited or large excision, primary closure, or flap techniques, and many other non-surgical methods. However, no consensus has been reached regarding the ideal treatment method. An ideal surgical treatment reduces recurrence and complication rates, and allows for minimal hospitalization and rapid return to daily activities. Among patients treated using the limited excision and primary closure method, the presence of a natal cleft is associated with higher morbidity, resulting in recurrence rates of 7-42%. For techniques that use the flap approach, this rate decreases to 0-3%. In patients undergoing the Rhomboid excision and Limberg flap techniques, which require a larger surgical area compared to the limited excision and primary closure methods, complication rates are lower, and length of hospital-stay and time to return to work are reduced. However, using the classical Limberg flap technique, maceration and scar formation due to sutures in the inter-gluteal sulcus, and the accumulation of hair at the midline may result in recurrence. Application of a modified Limberg technique that includes lateralization of the middle line can help reduce wound complications and recurrence rates. Several publications report contradicting results regarding surgical outcomes using the same technique, which may be attributable to differences in practice between surgeons. Therefore, it can be logical to explore the superiority of any type of surgical technique performed by the same surgeon for the surgical treatment of pilonidal sinus disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Closure | – | Procedure: surgery for pilonidal sinus diseasePatients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: primary closure. Technical details: An elliptical incision was made, and the excision included sinus openings at the median line and extended down to the pre-sacral fascia. One suction drain was placed in the wound cavity. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and skin was closed with interrupted 2-0 silk suture. |
| Limberg Flap Technique | – | Procedure: surgery for pilonidal sinus diseasePatients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: Limberg Flap Technique. Technical details: A rhomboid incision was made as to include all sinus openings, and an excision was made down to the pre-sacral fascia. A bisector drawn in the rhombohedron was extended laterally to a length similar to that of a corner of the rhombohedron. Then, the flap was prepared by removing gluteal muscle with its fascia. One suction drain was placed at the wound cavity. The base of the flap was approximated with the presacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable sutures, and the skin was closed with interrupted 3-0 prolene suture. |
| Modified Limberg Technique | – | Procedure: surgery for pilonidal sinus diseasePatients with pilonidal sinus disease treated with surgery for pilonidal sinus disease. Technique: Modified Limberg Flap Technique. Technical details: As in Limberg flap technique, a rhomboid incision was made. Upper and lower corners of the excision were lateralized 2 cm away from the midline in order to keep the suturing line at the inferior from overlapping the midline. An excision was made down to the pre-sacral fascia. One suction drain was placed at the wound cavity, and the base of the flap was approximated with the pre-sacral fascia at the excised area with interrupted 2-0 absorbable sutures. Subcutaneous tissue was approximated with interrupted 2-0 absorbable suture, and the skin was closed with 3-0 prolene. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 1082 patients who were diagnosed with pilonidal sinüs disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015.
Key inclusion criteria (1 listed)
- patients who were diagnosed with pilonidal sinus disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015
Key exclusion criteria (1 listed)
- patients with incomplete personal and medical data and who could not be contacted by direct interview or by telephone
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 sinus diseasesurgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique. | Procedure or surgery | Limberg Flap Technique, Modified Limberg Technique, Primary Closure |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion at an average of 36 months
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 29 Jul 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.
mustafa hasbahceci, assoc. prof. principal investigator
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus, run by Bezmialem Vakif University.
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 1 inclusion and 1 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: through study completion at an average of 36 months). 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 29 Jul 2016.