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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Denmark1 site
  • Nordsjaellands Hospital

    Hillerød, 3400

Other trials in Denmark

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.

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.

  1. Treatment failure assessed by clinical assessment or by questionnaire

    Incomplete wound healing or recurrence after complete wound healing

    Measured: 10 years

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted30 Aug 2021
  2. Study start1 Aug 2007
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

Resources

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
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 22142576
  • Serup 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

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.

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