Long-term Outcome After Cleft-lift for Pilonidal Sinus Disease
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus; Paranasal Sinus Diseases
Study type: Observational

Summary: 
      Single-center cohort study of 10-year risk of treatment failure after cleft-lift under
      tumescent local analgesia 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 (CL)has been performed in complicated cases not suitable for PP
      operation, recurrences following previous excisions, including PP, and unhealed midline
      wounds.

      CL has mainly been performed under tumescent local analgesia (TLA) in a day-surgery setting.
      TLA is well tolerated with high patient satisfaction and acceptable short-term outcomes. TLA
      provides a potentially higher cost-effectiveness not requiring presence of an
      anesthesiologist, shorter duration of the complete procedure and elimination of the risks and
      discomforts associated with general anesthetics.

      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 procedure has been described previously and performed with minor modifications of the
      original description by John Bascom. All procedures were performed in a day-surgical setting.
      With the patient in the prone position, the natal cleft was opened and exposed by retraction
      with elastic bandage tape before the sterile surgical draping was applied. The resection area
      and a flap on the less affected side were outlined with the intention of 2-3 cm
      lateralization of the wound. A hockey incision was outlined in the distal part of the
      excision to achieve lateralization at the distal end of the wound. Subcutaneous TLA with a
      modified Klein's solution containing mepivacaine 0.8 mg/mL, adrenaline 1 µg/mL, and sodium
      bicarbonate 42 µg/mL in isotonic saline water was infused through a 2-inch 21-gauge needle
      under a pressure of approximately 300 mm hg using a pressure infusion bag. If fibrous tissue
      affected the subcutaneous tissue, the solution was infiltrated by a 20-ml syringe. In case of
      pain during surgery, a supplementary tumescent solution was administered. If acceptable
      analgesia could not be obtained, intravenous sedation or analgesia was administrated at the
      patient's request.

      A flap with a thickness of approximately 7 mm was mobilized to the marked outer line to
      ensure tension-free tissue coverage of the excision. All primary pits in the midline were
      excised en-bloc, and all hair and granulation tissue in the subcutis was removed with a
      surgical swap or by curettage, saving as much fibrotic tissue as possible to provide padding.
      The retraction tape was released, and the surgical wound was closed with absorbable
      monofilament multilayer sutures subcutaneously with the intention of reducing any dead space
      in the subcutis before intracutaneous closure with polypropylene or monofilament short-term
      absorbable suture. A 10-French drain with no vacuum or silicon ribbon drains was placed under
      the flap. The wound was reinforced with strips and covered by a hydrofiber bandage. All
      patients received one dose of cefuroxime 1.5 g and metronidazole 1.0 g intravenously
      preoperatively, and cephalexin 500 mg and metronidazole 500 mg orally three times daily for
      three days as prophylaxis.

      Risk of recurrence 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. Time to complete wound healing is analyzed by Kaplan-Meier
      plots. Remaining outcomes are analyzed as categorical variables using descriptive data
      analyses.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with moderate to complex pilonidal sinus disease referred to a secondary and
        tertiary care hospital. Patients with history of surgery for pilonidal sinus disease are
        included in the cohort.
      
Keywords: Cleft-lift; Tumescent local analgesia