Error bars indicate SD.
Error bars indicate SD. P < .001.
eAppendix 1. Operative Phases of the Bascom Cleft Lift Procedure
eAppendix 2. Operative Phases of Video-Assisted Ablation Pilonidal Sinus
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Milone M, Fernandez LMS, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016;151(6):547–553. doi:10.1001/jamasurg.2015.5233
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.
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.
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.
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.
clinicaltrials.gov Identifier: NCT01963273.
Pilonidal sinus is a disease that most commonly arises in the hair follicles of the natal cleft of the sacrococcygeal area. Incidence is reportedly 26 per 100 000 population, affecting males twice as often as females and predominantly affecting young adults of working age.1,2
Although commonly encountered in practice, the optimal treatment of this disease has remained controversial since its first description by Mayo3 in 1833. Allen-Mersh4 performed an extensive review in 1990 of more than 90 articles on the treatment of pilonidal sinus. The review concluded that “the choice of a particular surgical approach is dependent on the surgeon's familiarity with the procedure and perceived results in terms of low recurrence of the sinus and of quick healing of the resulting cavity or surgical wound.”4(p1) This remark holds true 20 years later; the management of chronic pilonidal sinus is variable and subject to debate.5
A new minimally invasive endoscopic treatment of pilonidal sinus, video-assisted ablation of pilonidal sinus (VAAPS), has been proposed and has provided optimal preliminary results.6,7 Therefore, we decided to conduct a prospective randomized clinical trial to validate the safety and efficacy of this new treatment.
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. The study protocol was reviewed and approved by the local ethical committee of the University of Naples “Federico II” and was registered at the clinical trials registry of the National Institutes of Health (NCT01963273).8 The trial protocol can be found in Supplement 1. All patients were informed in detail about the potential risks and benefits of both operations and provided written informed consent for participation in the study. Additional consent was obtained for the surgical procedure once the patient was randomized.
The patients were included in the study if their chronic nonrecurrent sacrococcygeal pilonidal sinus was identified by an outpatient clinical evaluation. No patients previously treated by incision and drainage for the presence of an abscess were included in the study. In addition to a general indication for surgery, if signs of inflammation in the surrounding tissues were detected, antibiotic treatment was given to all patients, and the treatment was undertaken 2 or 3 weeks later when the inflammatory process was controlled. No restriction on return to work was given to any of the patients in either study group. The exclusion criteria were the inability to consent to participate in the study, acute pilonidal disease (the presence of an abscess), recurrent disease, and the presence of any comorbidity.
The primary end point of the study was time off work. To design a study with a 50% or greater minimal predefined reduction of time off work (1-5 days) with the minimally invasive treatment compared with the conventional treatment, at least 63 participants in each study arm were needed to achieve greater than 80% power with a 5% α error. The 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.
Patients were randomized to the conventional or minimally invasive treatment group using computer-based randomization with sealed envelopes after written informed consent had been obtained in the outpatient clinic. Using this strategy, we found that 163 patients were eligible for randomization and were subsequently randomized. Eighteen patients were excluded because of the following reasons: 9 patients denied consent to participate in the study, 8 patients had a diagnosis of recurrent pilonidal sinus at clinical evaluation, and 1 patient had a concomitant coagulopathy; therefore, 145 patients were included in the study. Seventy-six patients were randomized to the minimally invasive treatment group, and 69 patients were randomized to the conventional treatment group (Figure 1). Of interest, an additional 21 patients were excluded by randomization because of the diagnosis of acute pilonidal disease (an abscess). No patient was removed from the study because of persistent inflammation after antibiotic treatment.
All patients were operated on with standardized operation techniques. All operations were performed with the patient under local anesthesia with 30 to 60 mL of mepivacaine (Carbosen, 20 mg/mL; Galenica Senese). All patients were placed in the prone position with the hips slightly flexed. The buttocks were retracted with adhesive tape.
The Bascom cleft lift procedure was performed in the conventional treatment group, and the VAAPS procedure was performed in the minimally invasive treatment group. To minimize the bias related to the intraoperator difference, we have included only the conventional procedures performed by expert surgeons (>200 conventional treatments of pilonidal sinus) and the minimally invasive treatments performed by one surgeon with the highest level of skill in VAAPS (M.M.).
The Bascom cleft lift and VAAPS procedures were performed according to validated criteria.6,7,9,10 Operative phases of both procedures are given in eAppendix 1 and eAppendix 2 in Supplement 2.
All patients were examined during follow-up with a standard physical examination after 1 day, 1 week, 1 month, and every 3 months thereafter for at least 1 year. This is an interim analysis at 1 year.
The data obtained by a competent observer, independent of the operating team, included age, sex, obesity, smoking status, sinus characteristics (the presence of multiple orifices and the distance of the lateral orifice from the midline), operative time, postoperative complications (infection and/or recurrence), pain, time off work, and satisfaction. Obesity, smoking, having a complex disease, and having a distance greater than 2 cm from the lateral orifice to the midline have been evaluated to be, according to validated criteria,11 potential predictors of postoperative complications. A body mass index (calculated as the weight in kilograms divided by height in meters squared) greater than 30 defined obesity. Operative success was defined as the achievement of complete healing. Wound infection was defined as redness and/or edema of the skin and/or discharge, and recurrence was defined as an additional occurrence of symptoms of the disease after an interval following complete wound healing.
Patients were also asked to report their pain on a 10-cm visual analog scale, which ranged from 0 for no pain to 10 for severe pain, for their pain 6 hours, 1 day, 1 week, and 1 month after surgery and for their satisfaction 1 month and 6 months after surgery. The scale was constructed with numeration, thus allowing patients to mark a point along the scale that best represented their health status at that time. An independent observer, unaware of surgical intervention, collected the visual analog scale evaluation at each time point. Pain evaluation included only pain while resting or moving.
Conversely, the criteria for returning to work was the absence of any limitation to normal daily activities, including no pain while resting or moving, no pain while walking and sitting, and the lack of a need to dress the wound more than once a day.
Of interest, only outpatient procedures were performed in both groups. Instructions at discharge included only the improvement of local hygiene and the regular removal of hairs by shaving or the use of a depilatory cream for 6 weeks.
Statistical analysis was performed with SPSS statistical software, version 16.0 (SPSS Inc). The Yates corrected χ2 test was used to evaluate differences in the categorical variables, and the independent-sample t test was used to analyze continuous variables. To adjust for covariates and to make predictions, linear and logistic regression models were used. Statistical significance was accepted at P < .05.
A total of 145 patients with chronic nonrecurrent pilonidal sinus were randomized to minimally invasive (76 patients) or conventional (69 patients) treatment for pilonidal sinus. The follow-up rate was 100% at 1 year. The 2 groups were similar in terms of sex, age, obesity, and smoking status. The sinus characteristics were almost identical in both groups (Table). Of interest, the mean (SD) distance from the most lateral orifice to the midline was similar in the minimally invasive and conventional treatment groups (2.7 [0.6] vs 2.6 [0.7] cm; P = .80). Similarly, a distance greater than 2.5 cm from the midline was equally distributed in both groups (31 [40.7%] vs 28 [40.5%]; P > .99) (Table).
The mean (SD) operative time was less for the conventional treatment than for the minimally invasive treatment groups (42.9 [9.8] vs 26.5 [8.7] minutes; P < .001). The overall complication rate was similar in both groups (Table), and although fewer infections (1 [1.3%] vs 5 [7.2%]; P = .10) were recorded in the minimally invasive treatment group, this difference was not statistically significant (Table). Of interest, after adjusting for all other variables (sex, age, obesity, smoking status, and complex disease), only the distance of the lateral orifice from midline greater than 2.5 cm was found to be associated with an increased risk of postoperative complications (hazard ratio, 9.62; 96% CI, 2.05-45.25; P = .004).
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) (Figure 2). Similarly, after adjusting for all other variables (sex, age, obesity, smoking status, complex disease, and the distance of the lateral orifice from the midline), the minimally invasive treatment was associated with less time off work (β = .08, P < .001). Furthermore, no significant correlation (1-way analysis of variance) was found between the type of occupation and time off work (P = .78). Of interest, a significant correlation was detected between time off work and pain at 1 week (r = .05, P < .001) and pain at 1 month (r = .06, P < .001) (Figure 3).
The postoperative visual analog scale scores are reported in Figure 4. In detail, patients enrolled in the minimally invasive treatment group expressed significantly less pain at each time point evaluation (1 hour, 6 hours, 1 day, 1 week, and 1 month after surgery; P < .001 at all time points). Accordingly, after all other variables were adjusted for, patients in the minimally invasive treatment group expressed less pain at 1 hour (β = .08, P < .001), 6 hours (β = .07, P < .001), 1 day (β = .09, P < .001), 1 week (β = .09, P < .001), and 1 month (β = .04, P < .001) after surgery.
Postoperative satisfaction is reported in Figure 5. In detail, patients enrolled in the minimally invasive treatment group expressed higher satisfaction at 1 month and 6 months after surgery (P < .001 for all). Accordingly, after all other variables were adjusted for, patient satisfaction was higher in the minimally invasive treatment group (β = .10, P < .001, and β = .04, P < .001, respectively, at 1 and 6 months after surgery).
This is the first randomized clinical trial, to our knowledge, to compare conventional and endoscopic minimally invasive treatment of pilonidal sinus (VAAPS). Although numerous surgical treatment methods have been identified, there is no consensus on the optimal treatment in the literature. There is not a high level of evidential data for ideal treatment selection.5 The ideal therapy would be a quick cure that allowed patients to return rapidly to normal activity, with minimal morbidity and a low risk of complications.
The principles of treatment require complete removal of the sinus cavity, complete healing of the overlying skin, and the prevention of recurrence.1 Patients who require surgery for chronic pilonidal disease may undergo excision and primary repair (with consideration for off-midline closure), excision with healing by secondary intention, or excision with marsupialization based on the surgeon and patient preferences. Drain use should be individualized.12-18
However, conventional surgical interventions (both open healing and primary repair) leave a large and deep wound, disabling patients for several weeks.19-21 This occurrence leads to substantial medical resource consumption and high costs owing to the long time off work. In this context, an alternative treatment of pilonidal sinus is warranted.
The idea of treating pilonidal sinus less radically is not new and goes back to World War II. Phillips22 suggested a less invasive marsupialization of infected pilonidal sinuses “to keep the fighting man in a fit condition for combat.”22(p 329) In 1970, Patey23 recommended, “Don’t take a hammer to swat a fly!”23(p 940) and discussed a differentiated treatment. Lord and Millar24,25 introduced debridement of the pilonidal sinus with a rounded brush. Bascom26,27 established a procedure that included a narrow excision of the pilonidal orifices combined with a laterally placed parallel incision for debridement of the cavity.
In the last decade, minimally invasive treatment of pilonidal sinus has been proposed,28-30 supported by the theory that less is more. Minimally invasive treatments for pilonidal sinus consist of circumferential incision of the pilonidal orifices avoiding wide cutaneous margins and a selective subcutaneous extirpation of the sinus without closure of the wound (sinusectomy). Both procedures, sinusectomy29 and sinusectomy by trephines,30 have achieved good preliminary results in terms of time off work and recurrence rates.
A new endoscopic treatment for pilonidal sinus has been proposed.6,7,31 We designed VAAPS, which is based on the concept of complete removal by ablation of the sinus with a minimal surgical wound. Whereas in the conventional surgical treatment an elliptical wedge of skin and subcutaneous tissue is created to remove the sinus and its lateral tracks, the theory of our new treatment is to create a minimal elliptical wedge of the subcutaneous tissue, including all the inflamed tissue and debris, leaving the overlying skin intact. In our preliminary experience with 27 patients,6 the patients immediately returned to normal activities and work and had low recurrence rates.
Of interest, Meinero et al7 designed a similar minimally invasive treatment to treat pilonidal sinus and obtained good results in 11 consecutive patients. These findings were later confirmed by the experience of Chia et al31 with 9 consecutive patients.
Although the mechanism of treatment is similar to the sinusectomy,29,30 the video-assisted magnified view by the endoscope allows for the accurate identification of the sinus cavity, all lateral tracks, and the presence of hair inclusion in the cavity. The complete removal of the sinus cavity and all lateral tracks, coupled with hair identification and removal, should avoid infections and, above all, recurrences. Furthermore, the minimal scar (5-mm wide and 2-mm deep) caused by this minimally invasive treatment (left to heal by secondary intention) allows for very fast healing, rapid return to work, and an optimal aesthetic appearance.
The aim of this study was to verify the superiority of this minimally invasive treatment over the validated conventional treatment in obtaining rapid return to work. This is the first study, to our knowledge, to compare a minimally invasive treatment with a conventional treatment of pilonidal sinus.
To validate the results obtained by the VAAPS procedure, we chose an off-midline procedure as the comparison group; indeed, according to the Practice Parameters for the Management of Pilonidal Disease,14 patients who require surgery for chronic pilonidal disease may undergo excision and primary repair with consideration for off-midline closure. In detail, we have decided to perform the Bascom cleft lift procedure, which can be performed in 1 day.32,33 For patients who underwent surgical closure, there was a clear advantage to off-midline closure compared with midline closure.5 Fewer infections, recurrences, and other complications occurred and wound healing was quicker after off-midline closure compared with midline closure. Although similar results were provided by different off-midline techniques during the early period,5 the Bascom cleft lift procedure is a reliable technique that requires shorter operation time and results in a better quality of life during the early postoperative period.32-34
Our results indicate that the minimally invasive VAAPS procedure is more effective than the conventional treatment in facilitating rapid return to normal activity (time off work) and in pain management after surgery. In addition, the levels of patient satisfaction and aesthetic appearance are high.
Furthermore, we found that the minimally invasive treatment could be an effective and feasible treatment for pilonidal sinus with a similar rate of postoperative complications compared with the conventional treatment. Fewer infections were recorded in the minimally invasive treatment group, and a similar recurrence rate was registered, providing evidence of the noninferiority of the minimally invasive treatment compared with conventional off-midline closure. However, the recurrence rate needs to be further evaluated for a longer term. The short-term follow-up (1 year) does not allow us to draw definitive conclusions about the recurrence rate of the minimally invasive treatment. Long-term follow-up (5 years), according to Doll,35 should be considered the criterion standard in pilonidal sinus surgery benchmarking.
Another limitation of the present study is the relatively small sample size, which prevents conclusive results even if the results are adjusted for all the other variables in the multivariate regression analysis and all P values are highly significant. However, the advantages of our new technique are evident: there are no surgical wounds on the buttocks, there are minimal patient inconveniences with minimal pain and wound care, and the technique facilitates immediate return to work and normal activities. Thus, although further studies are mandatory to validate its effectiveness, our results support the adoption of this technique in daily practice.
Accepted for Publication: October 25, 2015.
Corresponding Author: Marco Milone, MD, Department of Advanced Biomedical Sciences, University of Naples “Federico II,” Via Pansini 5, 80131 Naples, Italy (firstname.lastname@example.org).
Published Online: January 27, 2016. doi:10.1001/jamasurg.2015.5233.
Author Contributions: Drs M. Milone and F. Milone had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: F. Milone.
Acquisition, analysis, or interpretation of data: M. Milone, Fernandez, Musella.
Drafting of the manuscript: Fernandez.
Critical revision of the manuscript for important intellectual content: M. Milone, Musella, F. Milone.
Obtained funding: M. Milone, Musella.
Administrative, technical, or material support: M. Milone, Musella.
Study supervision: M. Milone, Musella, F. Milone.
Conflict of Interest Disclosures: None reported.