Pilonidal DiseasePILOPERFONCT03534700
Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease.
A study testing parasacral flap reconstruction and open excision in people with Pilonidal Disease, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- parasacral flap reconstruction and open excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2018to 25 Sep 2023
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with primary or recurrent sacrococcygeal pilonidal sinus disease,
- Minimum delay of 1 month after an infection of the pilonidal areas,
Who cannot join
- Florid abcess in the pilonidal sinus,
- Impossibility of general anesthesia, allergy to methylene blue, anticoagulant therapy,
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Montpellier, 34295
University hospital
Toulouse, 31059
About this study
Official title: Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease. A Randomized Controlled Study.
Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school.
Various surgical procedures have been described for the treatment of both primary and recurrent pilonidal disease counting: open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.
Read more
No single method has been accepted as the "gold standard", and none of them cancels the risk of recurrence.
The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic outcomes and a low recurrence rate. It must allow the return to normal activities quickly.
The parasacral perforator flap seems to answer these entire requirements. No study compares this flap repair with the most common procedure, which is the open excision with secondary healing. The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.
Read the detailed description
Many studies seem to attest the superiority of excision and reconstruction of the natal cleft with a flap rather than the open excision with secondary healing. Jamal et al. found a significantly lower recurrence rate with a rhomboid excision and reconstruction with a Limberg flap versus open excision and secondary healing (p=0.005) in a prospective controlled randomized trial including 49 patients. Keshuari et al. obtained the same significant results in their prospective controlled randomized study including 321 patients, with a rate of 1.2% of recurrence in the Karidakis flap repair cluster versus 7.5% in the excision with healing by secondary intention cluster. The time for complete wound healing was also significantly amended .
The reconstruction of the natal cleft with a Karydakis or Limberg flap seemed to be superior in terms of recurrence compared to open excision. But those flaps led to a significant and discernable scar.
The parasacral perforator flap has been described by Garrido et al. in 2002. It appears to be a good alternative, offering all the benefits of the reconstruction of the natal cleft in terms of lower rate of recurrence and lower time for complete wound healing. It also gives a better aesthetic result.
In this trial, patients will be operated under general anesthesia. A Methylene blue injection will identify the limits of the pilonidal sinus. An excision of the whole width of the relevant area will be performed, with depth reaching the presacral fascia. In the A group, a parasacral perforator flap repair of the natal clef will be done, and in the B group healing by secondary intention by dressing will be performed. Patients will be followed in consultation at 15 days, 3 months, 6 months, 1 year and 2 years.
During these visits, a potential clinical recurrence will be detected, the time to be completely healing will be evaluated, the period of loss of normal activities will be noted, the quality of life will be assessed by a standardized generic measure (EQ-5D-5L) and by a specific score (DLQI), and post-operative complications will be collected.
The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.
A medico-economic analysis evaluating the incremental cost-effectiveness and cost-utility ratio will be also done at 2 years. Additionally, an evaluation of the production costs of the new strategy (i.e. parasacral perforator flap) will be performed from the specific perspective of hospitals.
- Conditions
- Pilonidal Disease
- Being tested
- parasacral flap reconstruction, open excision
- Keywords
- sacrococcygeal pilonidal disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parasacral flap reconstructionProcedure or surgery
parasacral flap reconstruction
open excisionProcedure or surgery
open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.
| Study group | Role | What they receive |
|---|---|---|
| Open excision | Active comparator | open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap. Receives: Procedure: open excision |
| parasacral flap reconstruction | Experimental | The parasacral perforator flap has been described. It appears to be a good alternative, offering all the benefits of the reconstruction of the natal cleft in terms of lower rate of recurrence and lower time for complete wound healing. It also gives a better aesthetic result. Receives: Procedure: parasacral flap reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
the rate of recurrence during a follow up of 2 years.
Measured: 2 years
Secondary outcomes (2)
cost-effectiveness
Incremental cost-effectiveness evaluation of comparative perforation flap surgery to the reference strategy in patients with pilonidal sinus cysts : the number of recurrences at 24 month
Measured: 2 years
cost-utility
Incremental cost-utility ratios
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jun 2018
- Primary completion1 Sep 2020
- Study completion25 Sep 2023
Why it stopped: decision of the PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit CHAPUT, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534700
- Sponsor's protocol ID
- RC31/16/8255
- Acronym
- PILOPERFO
- Status last verified
- Jan 2024
- First submitted
- 24 Nov 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excision and Reconstruction of the Natal Cleft With a Parasacral Perforator Flap Versus Open Excision With Secondary Healing, in the Management of Sacrococcygeal Pilonidal Disease. A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03534700
- Acronym / sponsor ID
- PILOPERFO / RC31/16/8255
- Conditions
- Pilonidal Disease
- Keywords
- sacrococcygeal pilonidal disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decision of the PI
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 23 May 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.
Chronic sacrococcygeal pilonidal disease is a common acquired condition associated with hirsutism that predominantly affects young male patients. Morbidity from this disease results in pain, embarrassment and loss of normal activities, causing absenteeism from work and school.
Various surgical procedures have been described for the treatment of both primary and recurrent pilonidal disease counting: open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.
No single method has been accepted as the "gold standard", and none of them cancels the risk of recurrence.
The optimal therapy for pilonidal sinus disease should be simple, with good aesthetic outcomes and a low recurrence rate. It must allow the return to normal activities quickly.
The parasacral perforator flap seems to answer these entire requirements. No study compares this flap repair with the most common procedure, which is the open excision with secondary healing. The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.
Detailed description
Many studies seem to attest the superiority of excision and reconstruction of the natal cleft with a flap rather than the open excision with secondary healing. Jamal et al. found a significantly lower recurrence rate with a rhomboid excision and reconstruction with a Limberg flap versus open excision and secondary healing (p=0.005) in a prospective controlled randomized trial including 49 patients. Keshuari et al. obtained the same significant results in their prospective controlled randomized study including 321 patients, with a rate of 1.2% of recurrence in the Karidakis flap repair cluster versus 7.5% in the excision with healing by secondary intention cluster. The time for complete wound healing was also significantly amended .
The reconstruction of the natal cleft with a Karydakis or Limberg flap seemed to be superior in terms of recurrence compared to open excision. But those flaps led to a significant and discernable scar.
The parasacral perforator flap has been described by Garrido et al. in 2002. It appears to be a good alternative, offering all the benefits of the reconstruction of the natal cleft in terms of lower rate of recurrence and lower time for complete wound healing. It also gives a better aesthetic result.
In this trial, patients will be operated under general anesthesia. A Methylene blue injection will identify the limits of the pilonidal sinus. An excision of the whole width of the relevant area will be performed, with depth reaching the presacral fascia. In the A group, a parasacral perforator flap repair of the natal clef will be done, and in the B group healing by secondary intention by dressing will be performed. Patients will be followed in consultation at 15 days, 3 months, 6 months, 1 year and 2 years.
During these visits, a potential clinical recurrence will be detected, the time to be completely healing will be evaluated, the period of loss of normal activities will be noted, the quality of life will be assessed by a standardized generic measure (EQ-5D-5L) and by a specific score (DLQI), and post-operative complications will be collected.
The aim of this study is to assess the efficacy and the security of the reconstruction of the natal cleft with the perforator parasacral flap versus open excision with secondary healing in the treatment of sacrococcygeal pilonidal sinus.
A medico-economic analysis evaluating the incremental cost-effectiveness and cost-utility ratio will be also done at 2 years. Additionally, an evaluation of the production costs of the new strategy (i.e. parasacral perforator flap) will be performed from the specific perspective of hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open excision | Active comparator | Procedure: open excisionopen excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap. |
| parasacral flap reconstruction | Experimental | Procedure: parasacral flap reconstructionThe parasacral perforator flap has been described. It appears to be a good alternative, offering all the benefits of the reconstruction of the natal cleft in terms of lower rate of recurrence and lower time for complete wound healing. It also gives a better aesthetic result. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with primary or recurrent sacrococcygeal pilonidal sinus disease,
- Minimum delay of 1 month after an infection of the pilonidal areas,
Key exclusion criteria (2 listed)
- Florid abcess in the pilonidal sinus,
- Impossibility of general anesthesia, allergy to methylene blue, anticoagulant 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 |
|---|---|---|
| parasacral flap reconstructionparasacral flap reconstruction | Procedure or surgery | parasacral flap reconstruction |
| open excisionopen excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap. | Procedure or surgery | Open excision |
Primary outcome
recurrence
Time frame: 2 years
the rate of recurrence during a follow up of 2 years.
2 secondary outcomes
cost-effectiveness
Time frame: 2 years
cost-utility
Time frame: 2 years
Results and safety
The study was stopped early (reason given: decision of the PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pilonidal Disease
Recruiting
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Pilonidal Disease
Recruiting
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Pilonidal Sinus Disease
Not yet recruiting
Teach-Back Discharge Education After Pilonidal Sinus Surgery
Pilonidal Sinus Disease, Pilonidal Sinus Treatment
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
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.
Benoit CHAPUT, MD principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parasacral flap reconstruction and open excision in people with Pilonidal Disease, run by University Hospital, Toulouse at 2 sites in France.
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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 (reason given: decision of the PI). 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?
recurrence (time frame: 2 years). 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 3 Jan 2024.