Sacrococcygeal Pilonidal DiseaseNCT02116738
Modified Limberg Procedure Versus Lateral Advancement Flap With Burrow's Triangle Procedure in the Treatment of Pilonidal Sinus
A study testing Flap Transposition Procedures in people with Sacrococcygeal Pilonidal Disease, run by Ankara Mevki Military Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacrococcygeal Pilonidal Disease
- What is being tested?
- Flap Transposition Procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Aug 2013
- Phase
- Interventional
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Pilonidal Sinus Disease
- Must be able to suitable for the surgery
Who cannot join
- Patients with Recurrent Pilonidal Sinus disease
- Patient whom is not suitable for surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Mevki Military Hospital : General Surgery Department
Ankara, 06110
About this study
Official title: Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease
The investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.
Read the detailed description
Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.
- Conditions
- Sacrococcygeal Pilonidal Disease
- Being tested
- Flap Transposition Procedures
- Keywords
- flap, pilonidal sinus, vas, 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.
Flap Transposition ProceduresProcedure or surgery
Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases
| Study group | Role | What they receive |
|---|---|---|
| Flap Transposition Technique | Experimental | Flap Transposition Technique Receives: Procedure: Flap Transposition Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sacrococcygeal Pilonidal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Mevki Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD. Mehmet SAYDAM (General Surgeon), Ankara Mevki Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116738
- Sponsor's protocol ID
- GMMA-LEC-001642
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.
PubMed 23173633
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of the Relatively New Surgical Techniques on the Treatment of Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT02116738
- Acronym / sponsor ID
- GMMA-LEC-001642
- Conditions
- Sacrococcygeal Pilonidal Disease
- Keywords
- flap, pilonidal sinus, vas, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ankara Mevki Military HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Apr 2014 (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 investigators want to share our study that is the "Comparison of Modified Limberg Flap Transposition and Lateral Advancement Flap Transposition with Burrow's Triangle in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus.
Detailed description
Pilonidal Sinus Disease (PSD) is a common and chronic entity of the young adults. So far, many options regarding the surgical treatment of the disease has been described, the consensus about treatment stills remains unsatisfactory, as all the surgical methods have encountered with different rate of recurrences. Our aim in this study is to compare the widely used technique in pilonidal sinus surgical treatment Modified Limberg Flap Transposition and relatively less used technique Lateral Advancement Flap Transposition with Burrow's Triangle, in the terms of VAS scores, recurrence, postoperative complications, surgical site infections in the first 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flap Transposition Technique | Experimental | Procedure: Flap Transposition ProceduresFlap Transposition Technique |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Pilonidal Sinus Disease
- Must be able to suitable for the surgery
Key exclusion criteria (2 listed)
- Patients with Recurrent Pilonidal Sinus disease
- Patient whom is not suitable for surgery
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 |
|---|---|---|
| Flap Transposition ProceduresModified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases | Procedure or surgery | Flap Transposition Technique |
Primary outcome
Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS)
Time frame: 12 hours
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 17 Apr 2014.
- Background: PubMed 23173633Yuksel BC, Berkem H, Ozel H, Hengirmen S. A new surgical method of pilonidal sinus treatment: a bilaterally paralel elliptic fascio-cutaneous advancement flap technique. Bratisl Lek Listy. 2012;113(12):728-31. doi: 10.4149/bll_2012_165.
- Turkish Surgical AssociationLink provided by the sponsor.
Related trials for Sacrococcygeal Pilonidal Disease
Recruiting
LASER VERSUS CRYSTALLIZED PHENOL IN PILONIDAL SINUS DISEASE
Sacrococcygeal Pilonidal Sinus Disease, Pilonidal Sinus Disease
Not yet recruitingObservational study
Effectiveness of Different Surgical Techniques for Curative Treatment of Pilonidal Sinus Disease in the Pediatric Population
Sacrococcygeal Pilonidal Sinus
Not yet recruiting
Silac Versus Phenol for the Treatment of Pilonidal Sinus Disease: A Randomized Controlled Trial
Pilonidal Sinus Disease
RecruitingObservational study
Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Pilonidal Sinus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flap Transposition Procedures in people with Sacrococcygeal Pilonidal Disease, run by Ankara Mevki Military 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 2 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 17 Apr 2014. 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?
Percentage of Participants with a 95% Decrease in Pain Visual Analogue Scale (VAS) (time frame: 12 hours). 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 NCT02116738, which also lists 1 linked publication.
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 17 Apr 2014.