Long-term Outcome After Bascom's Cleft-lift Procedure Under Tumescent Local Analgesia for Pilonidal Sinus Disease: a Cohort Study

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.