Pilonidal Sinus of Natal CleftNCT05027607
Long-term Outcome After Pit-pick for Simple Pilonidal Sinus Disease
An observational study of Pilonidal Sinus of Natal Cleft, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Single-center cohort study of long-term results after pit-pcik for pilonidal sinus disease. Read more about this study
- Who is it for?
- Ages 14 to 99 years
- Conditions the study is for
- Pilonidal Sinus of Natal Cleft
- What is being tested?
- Bascom's pit-pick
- Type of treatment
- Surgery or procedure
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2007to 31 May 2021
- How long will I take part?
- 10 Years
- 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 14 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with simple pilonidal sinus disease referred to a secondary and tertiary care hospital. Prior surgery for pilonidal sinus disease included in the cohort.
Who may be able to join
- Undergoing pit-pick at Nordsjællands Hospital during the study period
Who cannot join
- Included in project investigating novel wound dressing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcome After Bascom's Pit-pick Procedure for Pilonidal Sinus Disease: a Cohort Study
Single-center cohort study of long-term results after pit-pcik for pilonidal sinus disease.
Read the detailed description
The standard treatment at Nordsjællands Hospital in Hillerød (NOH) has since 2007 been Bascom's pit-pick procedure (PP) for simple pilonidal sinus disease (PSD), while Bascom's cleft-lift procedure has been performed in complicated cases not suitable for PP operation, recurrences following previous excisions, including PP, and unhealed midline wounds. PP operation is a minimally invasive procedure performed using local anesthesia in day surgery or outpatient clinic with certain advantages such as quick healing, less pain and a quick return to work as well as cosmetic advantages with no change to the overall appearance and shape of the gluteal cleft. The procedure is less resource demanding requiring fewer staff members and less time spent at the hospital as well as a quick return to daily life. Short-term studies showing great results following PP operation have previously been published, but so far, no long-term results have been published regarding Danish patients. Furthermore, it has previously been stated that most recurrences happen within the first 5 years following surgery. A follow-up of at least 5 years after surgery for PSD has been proposed as the gold standard. A longer follow-up is warranted to fully understand, whether PP procedure is a fully adequate treatment with an acceptable rate of recurrence and patient satisfaction or whether it only delays the time before the patients eventually undergo a final treatment.
The study is based on data of patients in a local pilonidal database. The patients in the database have all undergone surgery for pilonidal sinus disease at NOH during the period of 2007 to 2014. Data in the database has been collected prospectively up to one year following surgery and subsequently supplemented with data collected by questionnaire and telephone interviews for the period from one year follow-up and until the date of long-term follow-up. Study data were collected and managed using REDCap electronic data capture tools hosted at NOH.
Patients receive a REDCap survey per e-mail to a personal digital mailbox or are asked to participate in a telephone interview to fill out a standardized questionnaire. Patients without a personal digital mailbox receive the questionnaire by regular mail. The survey is sent out twice with a four-week interval. Only patients who do not fill out the questionnaire the first time, receive the survey a second time as a reminder. Telephone interviews are only conducted, if patients do not reply to the questionnaire received digitally or as a physical copy. The questionnaire includes questions regarding demographic characteristics, lifestyle, complications, recurrence and new interventions, pain, and cosmetic satisfaction. Medical records are reviewed to verify answers from the questionnaire if consent by the patient is given through the survey or during the telephone interview. Patients experiencing symptoms of recurrence, are offered an assessment at the hospital.
The surgical intervention: the patient is placed in a prone position and the natal cleft is kept open using tape straps. Local analgesia is administered around the midline pits and at the site of the planned lateral incision using lidocaine 5 mg/ml with adrenaline 5 µg/ml. Occasionally the procedure was performed under general anesthesia. All midline pits are identified and excised using a scalpel removing hairs and infected granulation tissue. To drain the sinus, a lateral incision is made about 1-2 cm from the midline on the most appropriate side and through this incision underlying sinuses are either curetted or excised. Additional secondary pits are removed as part of the lateral incision. Midline wounds and separately excised secondary pits close to the midline are closed with suture using transcutaneous polypropylene 3-0 or 4-0 madras suture, while the lateral incision is left open and covered with bandage and transparent film dressing to heal by secondary intention.
Risk of recurrence and time to complete wound healing is analyzed using competing risk analysis as well as univariate and multivariate Cox regression analyses including the following risk factors: sex, age, smoking, BMI, relevant co-morbidities, diabetes mellitus, acne, hidradenitis, previous interventions, preoperative abscess, number of primary and secondary pits, number of lateral incisions and postoperative complications. Remaining outcomes are analyzed as categorical variables using descriptive data analyses.
- Conditions
- Pilonidal Sinus of Natal Cleft
- Being tested
- Bascom's pit-pick
- Keywords
- Pilonidal sinus, Pit-pick, Recurrence, Pain, Day Surgery
- Medical subject headings
- Pilonidal Sinus, Recurrence, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bascom's pit-pickProcedure or surgery
Pit-pick procedure of simple pilonidal sinus disease in the natal cleft in a day-surgery setting.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure assessed by clinical assessment or by questionnaire
Incomplete wound healing or recurrence after complete wound healing
Measured: 10 years
Secondary outcomes (2)
Chronic pain related to cicatrix
Numerical rate scale pain score (0-10). 0 being no pain and 10 being the the worst imaginary pain
Measured: 10 years
Cosmetic appearance of the cicatrix
Numerical rate scale score (1-5). 1 being worst, 5 the better
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Aug 2007
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Sinus of Natal CleftStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 158 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus A Bertelsen, PhD, Study chair, Department of Surgery, Copenhagen University Hospital - Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027607
- Sponsor's protocol ID
- PSD - pit-pick
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses.
Publications
Colov EP, Bertelsen CA. Short convalescence and minimal pain after out-patient Bascom's pit-pick operation. Dan Med Bull. 2011 Dec;58(12):A4348.
PubMed 22142576Serup CM, Svarre KJ, Kanstrup CTB, Kleif J, Bertelsen CA. Long-term outcome after Bascom's pit-pick procedure for pilonidal sinus disease: A cohort study. Colorectal Dis. 2023 Mar;25(3):413-419. doi: 10.1111/codi.16383. Epub 2022 Nov 13.
PubMed 36268754
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome After Bascom's Pit-pick Procedure for Pilonidal Sinus Disease: a Cohort Study
- ClinicalTrials.gov ID
- NCT05027607
- Acronym / sponsor ID
- PSD - pit-pick
- Conditions
- Pilonidal Sinus of Natal Cleft
- Keywords
- Pilonidal sinus, Pit-pick, Recurrence, Pain, Day Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 30 Aug 2021 (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.
Single-center cohort study of long-term results after pit-pcik for pilonidal sinus disease.
Detailed description
The standard treatment at Nordsjællands Hospital in Hillerød (NOH) has since 2007 been Bascom's pit-pick procedure (PP) for simple pilonidal sinus disease (PSD), while Bascom's cleft-lift procedure has been performed in complicated cases not suitable for PP operation, recurrences following previous excisions, including PP, and unhealed midline wounds. PP operation is a minimally invasive procedure performed using local anesthesia in day surgery or outpatient clinic with certain advantages such as quick healing, less pain and a quick return to work as well as cosmetic advantages with no change to the overall appearance and shape of the gluteal cleft. The procedure is less resource demanding requiring fewer staff members and less time spent at the hospital as well as a quick return to daily life. Short-term studies showing great results following PP operation have previously been published, but so far, no long-term results have been published regarding Danish patients. Furthermore, it has previously been stated that most recurrences happen within the first 5 years following surgery. A follow-up of at least 5 years after surgery for PSD has been proposed as the gold standard. A longer follow-up is warranted to fully understand, whether PP procedure is a fully adequate treatment with an acceptable rate of recurrence and patient satisfaction or whether it only delays the time before the patients eventually undergo a final treatment.
The study is based on data of patients in a local pilonidal database. The patients in the database have all undergone surgery for pilonidal sinus disease at NOH during the period of 2007 to 2014. Data in the database has been collected prospectively up to one year following surgery and subsequently supplemented with data collected by questionnaire and telephone interviews for the period from one year follow-up and until the date of long-term follow-up. Study data were collected and managed using REDCap electronic data capture tools hosted at NOH.
Patients receive a REDCap survey per e-mail to a personal digital mailbox or are asked to participate in a telephone interview to fill out a standardized questionnaire. Patients without a personal digital mailbox receive the questionnaire by regular mail. The survey is sent out twice with a four-week interval. Only patients who do not fill out the questionnaire the first time, receive the survey a second time as a reminder. Telephone interviews are only conducted, if patients do not reply to the questionnaire received digitally or as a physical copy. The questionnaire includes questions regarding demographic characteristics, lifestyle, complications, recurrence and new interventions, pain, and cosmetic satisfaction. Medical records are reviewed to verify answers from the questionnaire if consent by the patient is given through the survey or during the telephone interview. Patients experiencing symptoms of recurrence, are offered an assessment at the hospital.
The surgical intervention: the patient is placed in a prone position and the natal cleft is kept open using tape straps. Local analgesia is administered around the midline pits and at the site of the planned lateral incision using lidocaine 5 mg/ml with adrenaline 5 µg/ml. Occasionally the procedure was performed under general anesthesia. All midline pits are identified and excised using a scalpel removing hairs and infected granulation tissue. To drain the sinus, a lateral incision is made about 1-2 cm from the midline on the most appropriate side and through this incision underlying sinuses are either curetted or excised. Additional secondary pits are removed as part of the lateral incision. Midline wounds and separately excised secondary pits close to the midline are closed with suture using transcutaneous polypropylene 3-0 or 4-0 madras suture, while the lateral incision is left open and covered with bandage and transparent film dressing to heal by secondary intention.
Risk of recurrence and time to complete wound healing is analyzed using competing risk analysis as well as univariate and multivariate Cox regression analyses including the following risk factors: sex, age, smoking, BMI, relevant co-morbidities, diabetes mellitus, acne, hidradenitis, previous interventions, preoperative abscess, number of primary and secondary pits, number of lateral incisions and postoperative complications. Remaining outcomes are analyzed as categorical variables using descriptive data analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 14 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with simple pilonidal sinus disease referred to a secondary and tertiary care hospital. Prior surgery for pilonidal sinus disease included in the cohort.
Key inclusion criteria (1 listed)
- Undergoing pit-pick at Nordsjællands Hospital during the study period
Key exclusion criteria (1 listed)
- Included in project investigating novel wound dressing.
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 |
|---|---|---|
| Bascom's pit-pickPit-pick procedure of simple pilonidal sinus disease in the natal cleft in a day-surgery setting. | Procedure or surgery | – |
Primary outcome
Treatment failure assessed by clinical assessment or by questionnaire
Time frame: 10 years
Incomplete wound healing or recurrence after complete wound healing
2 secondary outcomes
Chronic pain related to cicatrix
Time frame: 10 years
Cosmetic appearance of the cicatrix
Time frame: 10 years
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 Mar 2023.
- Background: PubMed 22142576Colov EP, Bertelsen CA. Short convalescence and minimal pain after out-patient Bascom's pit-pick operation. Dan Med Bull. 2011 Dec;58(12):A4348.
- Background: PubMed 36268754Serup CM, Svarre KJ, Kanstrup CTB, Kleif J, Bertelsen CA. Long-term outcome after Bascom's pit-pick procedure for pilonidal sinus disease: A cohort study. Colorectal Dis. 2023 Mar;25(3):413-419. doi: 10.1111/codi.16383. Epub 2022 Nov 13.
- Individual participant dataSharing planned: Undecided. After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses.
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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.
Claus A Bertelsen, PhD study chair
Department of Surgery, Copenhagen University Hospital - Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pilonidal Sinus of Natal Cleft, run by Nordsjaellands Hospital at 1 site in Denmark.
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 Mar 2023. 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 Denmark. 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?
Treatment failure assessed by clinical assessment or by questionnaire (time frame: 10 years). 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 NCT05027607, which also lists 2 linked publications.
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 Mar 2023.