Pilonidal SinusNCT03271996
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
A study testing Primary closure and Fistulectomy in people with Pilonidal Sinus, run by Dimitri Christoforidis at 1 site in Switzerland.
Trial summary
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Primary closure and Fistulectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2012to Jun 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pilonidal cyst requiring surgery
- Signed Informed Consent Form
Who cannot join
- Abnormal lesions
- Injuries requiring a closing with rotation flap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
Read the detailed description
This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)
Group A: excision and paramedian closure according to modified Karydakis technique
Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention
- Conditions
- Pilonidal Sinus
- Being tested
- Primary closure, Fistulectomy
- Keywords
- Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary closureProcedure or surgery
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
FistulectomyProcedure or surgery
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
| Study group | Role | What they receive |
|---|---|---|
| Primary closure | Experimental | Excision of sinus and paramedian closure according to modified Karydakis technique Receives: Procedure: Primary closure |
| Fistulectomy | Experimental | Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention Receives: Procedure: Fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing
percentage of complete healing
Measured: 3 weeks
Secondary outcomes (2)
Time to recovery
Time to completely recovery
Measured: 12 months
percentage of relapse
percentage of relapse after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study startApr 2012
- Primary completionJun 2017
- Study completionJun 2017
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 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
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dimitri Christoforidis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dimitri Christoforidis, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271996
- Sponsor's protocol ID
- 11-016
- Status last verified
- Sep 2017
- First submitted
- 17 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Popeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6.
PubMed 32144531
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03271996
- Acronym / sponsor ID
- 11-016
- Conditions
- Pilonidal Sinus
- Keywords
- Pilonidal sinus, Bascom, Cleft lift, Fistulectomy, Karydakis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dimitri ChristoforidisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Sep 2017 (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 wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.
Detailed description
This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)
Group A: excision and paramedian closure according to modified Karydakis technique
Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Primary closure | Experimental | Procedure: Primary closureExcision of sinus and paramedian closure according to modified Karydakis technique |
| Fistulectomy | Experimental | Procedure: FistulectomyRemoval / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pilonidal cyst requiring surgery
- Signed Informed Consent Form
Key exclusion criteria (2 listed)
- Abnormal lesions
- Injuries requiring a closing with rotation flap
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 |
|---|---|---|
| Primary closureAsymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage. | Procedure or surgery | Primary closure |
| FistulectomyEvaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines | Procedure or surgery | Fistulectomy |
Primary outcome
Complete healing
Time frame: 3 weeks
percentage of complete healing
2 secondary outcomes
Time to recovery
Time frame: 12 months
percentage of relapse
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Derived from this study: PubMed 32144531Popeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6.
- 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.
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 Primary closure and Fistulectomy in people with Pilonidal Sinus, run by Dimitri Christoforidis at 1 site in Switzerland.
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: stopped early, as of the sponsor's last update on 5 Sep 2017. 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 Switzerland. 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 was stopped early. Results are not available in the source record.
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?
Complete healing (time frame: 3 weeks). 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 NCT03271996, 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 5 Sep 2017.