Pilonidal SinusNCT03765086
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
A study testing Karydakis procedure and Limberg Flap in people with Pilonidal Sinus, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Karydakis procedure and Limberg Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2017to 1 Jul 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pilonidal sinus of any sex and aged 20 years or above
- Non infected pilonidal sinus
Who cannot join
- Infected pilonidal sinus
- Uncontrolled diabetes
- Patient on immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
About this study
This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus
- Conditions
- Pilonidal Sinus
- Being tested
- Karydakis procedure, Limberg Flap
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karydakis procedureProcedure or surgery
Pilonidal sinus will be excised by Karydakis procedure
Limberg FlapProcedure or surgery
Pilonidal sinus will be excised by Limberg Flap
| Study group | Role | What they receive |
|---|---|---|
| Karydakis procedure | Active comparator | Karydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline. Receives: Procedure: Karydakis procedure |
| Limberg Flap | Active comparator | Limberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap. Receives: Procedure: Limberg Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting with recurrence of pilonidal sinus
Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure
Measured: 8 to 12 weeks
Secondary outcomes (2)
Number of weeks in which the operative wound will be healed
Duration of wound healing (complete epithelization of wound )
Measured: 4 to 6 weeks
percentage of patients developing postoperative pain
postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Aug 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765086
- Sponsor's protocol ID
- s7
- Status last verified
- Feb 2019
- First submitted
- 11 Jul 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus
- ClinicalTrials.gov ID
- NCT03765086
- Acronym / sponsor ID
- s7
- Conditions
- Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 5 Dec 2018 (actual)
- 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.
This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Karydakis procedure | Active comparator | Procedure: Karydakis procedureKarydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline. |
| Limberg Flap | Active comparator | Procedure: Limberg FlapLimberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pilonidal sinus of any sex and aged 20 years or above
- Non infected pilonidal sinus
Key exclusion criteria (3 listed)
- Infected pilonidal sinus
- Uncontrolled diabetes
- Patient on immunosuppressive therapy
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 |
|---|---|---|
| Karydakis procedurePilonidal sinus will be excised by Karydakis procedure | Procedure or surgery | Karydakis procedure |
| Limberg FlapPilonidal sinus will be excised by Limberg Flap | Procedure or surgery | Limberg Flap |
Primary outcome
Percentage of patients presenting with recurrence of pilonidal sinus
Time frame: 8 to 12 weeks
Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure
2 secondary outcomes
Number of weeks in which the operative wound will be healed
Time frame: 4 to 6 weeks
percentage of patients developing postoperative pain
Time frame: 3 days
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 5 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Karydakis procedure and Limberg Flap in people with Pilonidal Sinus, run by Services Hospital, Lahore at 1 site in Pakistan.
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 3 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 5 Feb 2019. 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 Pakistan. 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 patients presenting with recurrence of pilonidal sinus (time frame: 8 to 12 weeks). 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 5 Feb 2019.