Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial.

IMPORTANCE: Video-assisted ablation of pilonidal sinus (VAAPS) is a new minimally invasive treatment based on the complete removal of the sinus cavity with a minimal surgical wound.

OBJECTIVE: To validate the safety and efficacy of VAAPS.

DESIGN, SETTING, AND PARTICIPANTS: From January 1, 2012, through December 31, 2013, we enrolled 145 consecutive patients from an intention-to-treat population at a single academic center in Italy. The last date of follow-up for this analysis was December 31, 2014. Patients with chronic nonrecurrent pilonidal sinus were randomized to minimally invasive (76 patients) or conventional (69 patients) treatment of pilonidal sinus.

INTERVENTIONS: VAAPS and Bascom cleft lift procedure.

MAIN OUTCOMES AND MEASURES: The primary end point of the study was time off work. Secondary end points were the rates of operative success and perioperative complications (infection and recurrence), operative time, patient satisfaction, and intraoperative and postoperative pain ratings.

RESULTS: Of the 145 patients, 60 (78.9%) were male and 16 (21.1%) were female in the minimally invasive treatment group, and 54 (78.3%) were male and 15 (21.7%) were female in the conventional treatment group. The mean (SD) age of the patients was 25.5 (5.9) years in the minimally invasive treatment group and 25.7 (5.3) in the conventional treatment group. In the minimally invasive treatment group, mean (SD) time off work was significantly less compared with the conventional treatment group (1.6 [1.7] vs 8.2 [3.9] days; P < .001). Mean (SD) operative time was significantly longer in the minimally invasive treatment group (42.9 [9.8] minutes) vs the conventional treatment group (26.5 [8.7] minutes), P < .001. Although the overall complication rate was similar in both groups, there were fewer infections (1 [1.3%] vs 5 [7.2%]; P = .10) recorded in the minimally invasive treatment group. Similarly, patients enrolled in the minimally invasive treatment group expressed significantly less pain and higher satisfaction.

CONCLUSIONS AND RELEVANCE: In the new era of minimally invasive treatment surgery, pilonidal sinus could become a disease treated with an endoscopic approach. Although additional studies are needed to provide a definitive conclusion, our results encourage considering the adoption of this treatment as the most effective way to treat pilonidal sinus.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01963273.