Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05027607 |
| Other study ID # |
PSD - pit-pick |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2007 |
| Est. completion date |
May 31, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Nordsjaellands Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Single-center cohort study of long-term results after pit-pcik for pilonidal sinus disease.
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.
