ClinicalTrials.gg
CompletedNCT05027607Updated Mar 29, 2023

Long-term Outcome After Pit-pick for Simple Pilonidal Sinus Disease

An observational study in Pilonidal Sinus of Natal Cleft, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 14 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Nordsjaellands Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
158
Ages
14 Years to 99 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pilonidal Sinus of Natal Cleft

Keywords

  • Pilonidal sinus
  • Pit-pick
  • Recurrence
  • Pain
  • Day Surgery
03

In context

Pilonidal Sinus

109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.

This study's enrollment of 158 is close to the median of 145 across 37 observational studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Undergoing pit-pick at Nordsjællands Hospital during the study period

Exclusion criteria

Exclusion Criteria:

  • Included in project investigating novel wound dressing.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
158 participants (actual)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • ProcedureBascom's pit-pick

    Pit-pick procedure of simple pilonidal sinus disease in the natal cleft in a day-surgery setting.

06

What researchers measure

Primary outcomes

  1. Treatment failure assessed by clinical assessment or by questionnaire

    Incomplete wound healing or recurrence after complete wound healing

    Time frame: 10 years

Secondary outcomes

  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

    Time frame: 10 years

  2. Cosmetic appearance of the cicatrix

    Numerical rate scale score (1-5). 1 being worst, 5 the better

    Time frame: 10 years

07

Study locations

1 site
  • Nordsjaellands Hospital
    Hillerød, 3400, Denmark
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05027607
Lead sponsor
Nordsjaellands Hospital
Responsible party
Sponsor
First posted
Aug 30, 2021
Start date
Aug 1, 2007
Primary completion
May 31, 2021
Completion
May 31, 2021
Last update
Mar 29, 2023

Study contacts

Claus A Bertelsen, PhD
study chair · Department of Surgery, Copenhagen University Hospital - Nordsjaellands Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion