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Original Investigation |

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

Marco Milone, MD1; Loredana Maria Sosa Fernandez, MD1; Mario Musella, MD1; Francesco Milone, MD1
[+] Author Affiliations
1Department of Advanced Biomedical Sciences, University of Naples “Federico II,” Naples, Italy
JAMA Surg. 2016;151(6):547-553. doi:10.1001/jamasurg.2015.5233.
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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.

Figures in this Article

Figures

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Figure 1.
Flow Diagram of the Study Design
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Figure 2.
Mean Time Off Work After the Minimally Invasive and Conventional Treatments

Error bars indicate SD.

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Figure 3.
Scatterplot of Pearson Correlations Between Time Off Work and Pain Score at 1 Day and 1 Week After Operation
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Figure 4.
Mean Visual Analog Scale Pain Scores After the Minimally Invasive and Conventional Treatments

Error bars indicate SD. P < .001.

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Figure 5.
Satisfaction Scores After the Minimally Invasive and Conventional Treatments

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