Technical Comparison of Three Surgical Methods: Open, Semi-closure, and Primary Closure in the Treatment of Pilonidal Sinus

² Student Research Committee, Hamadan University of Medical Sciences, Hamadan, Iran

³ Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran

EXTENDED ABSTRACT

Background

Pilonidal sinus is a relatively common chronic infectious disease of the sacrococcygeal region. Surgical management remains challenging because several operative techniques are available and no single approach has achieved universal acceptance. The principal goals of treatment are to minimize postoperative complications and recurrence, accelerate wound healing, and facilitate recovery while avoiding prolonged hospitalization and excessive treatment burden. Open surgery, semi-closed surgery, and primary closure are among the commonly used approaches, but their relative advantages and disadvantages remain clinically relevant. In particular, wound-healing time, postoperative bleeding, pain, infection, recurrence, and treatment costs may influence the choice of technique. The present study was therefore conducted to determine and compare healing time, postoperative complications, and costs among patients undergoing open, semi-closed, or primary-closure surgery for pilonidal sinus.

Methods

This double-blind clinical trial was conducted from March to November 2023 at Imam Khomeini Hospital in Poldokhtar, Iran. Patients who were candidates for pilonidal sinus surgery were selected by convenience sampling. Eligibility criteria included being a candidate for surgery, having no previous history of pilonidal sinus surgery, and having no diabetes or malignancy. Patients unwilling to cooperate or unable to communicate were excluded. The minimum required sample size was estimated as 48 participants using Power G version 2.9.1.3, based on an effect size of 0.6, power of 0.95, and three study groups; 60 patients were ultimately enrolled to account for possible attrition. Block randomization allocated 20 patients to each of three groups: open, semi-closed, and primary closure. Allocation was concealed in sealed envelopes until surgery, and the patients and principal investigator were blinded to the surgical technique.

All patients underwent spinal anesthesia and were positioned prone after preparation and draping, with the buttocks separated using adhesive tape. The lesion was identified by methylene-blue injection before surgery. In the open group, the lesion was completely excised through an elliptical incision, meticulous dissection and hemostasis were performed, the cavity was packed with povidone-iodine gauze, and the wound was left open for healing. In the semi-closed group, the lesion was completely excised with an adequate tissue margin; the wound edges were approximated primarily in the midline without tension, with the upper half closed in two layers to facilitate drainage. The subcutaneous tissue was closed with absorbable 2/0 Vicryl and the skin with 3/0 nylon. In the primary-closure group, the lesion, surrounding healthy tissue, and all external openings were excised to the presacral fascia; a drain was placed, the subcutaneous tissues and presacral fascia were approximated with 2/0 Vicryl, and the skin was closed with 3/0 nylon. Analgesic and antibiotic regimens were standardized across groups. Data on age and sex were obtained from medical records. Blood loss was estimated from the suction bottle and by weighing dry and blood-soaked gauze. Wound discharge and infection were assessed using the Southampton scale on postoperative days 7, 14, and 21. Healing status and recurrence were assessed during follow-up for six months by telephone and in-person visits. Postoperative pain was measured using the McGill Pain Questionnaire (MPQ). Costs were calculated from patient payments and hospital accounting records. Statistical analysis was performed using SPSS version 16. Quantitative variables were described as mean (standard deviation) and qualitative variables as frequency (percentage). The Mann–Whitney U test was used for sex-specific comparisons, Kruskal–Wallis testing for quantitative comparisons among surgical groups, and the chi-square test to assess the association between surgical method and infection. The Shapiro–Wilk test was used to assess normality, and P<0.05 was considered statistically significant. The study received ethics approval (IR.UMSHA.REC.1402.024), informed consent was obtained, and the trial was registered under IRCT20230409057866N1.

Results

The study included 60 patients, with 20 patients (33.3%) in each surgical group. Overall, 48 patients (80%) were men and 12 (20%) were women. Patient age ranged from 13 to 42 years, with a mean age of 25.68 years. Across the study population, mean healing time was 56.60 days, with a range of 20 to 210 days. Recorded postoperative pain ranged from 0 to 47, with a mean score of 10.10, and mean blood loss was 31.33 cc, ranging from 15 to 50 cc. Regarding wound status, 10 patients (16.7%) had erythema without serous discharge, 28 (46.7%) had erythema with discharge, 20 (33.0%) had erythema with infected discharge involving half of the wound, and 2 (3.3%) had infected discharge involving the entire wound. Complete healing occurred in 35 patients (58.3%), relative healing with discharge in 23 (38.3%), and recurrent disease in 2 (3.3%). Regarding costs, 15 patients (25.0%) incurred costs above 350,000 tomans, 37 (61.7%) incurred costs of 350,000–700,000 tomans, and 8 (13.3%) incurred costs above one million tomans.

Sex-specific analysis showed that mean healing time was 59.40±41.84 days in men and 45.42±16.39 days in women; this difference was not statistically significant (P=0.488). Mean blood loss was 31.88±8.23 cc in men and 29.17±10.62 cc in women, also without a statistically significant difference (P=0.260). In contrast, postoperative pain was significantly higher in women, with mean scores of 17.08±15.12 versus 8.35±7.99 in men (P=0.015).

Comparison among surgical techniques demonstrated a statistically significant difference in healing time (Kruskal–Wallis H=28.781, P<0.001). Mean healing time was 77.70±33.93 days for open surgery, 50.40±51.46 days for primary closure, and 41.70±6.50 days for semi-closed surgery. Pairwise comparisons showed significantly longer healing after open surgery than after primary closure (P<0.001) and semi-closed surgery (P<0.001), whereas the difference between primary closure and semi-closed surgery was not significant (P=0.402). Mean postoperative pain was 14.30±15.24 in the open group, 7.70±4.96 in the primary-closure group, and 8.30±6.62 in the semi-closed group. Although pain was numerically higher after open surgery, the overall difference was not statistically significant (H=0.493, P=0.782).

Blood loss also differed significantly among the three techniques (H=9.557, P=0.008). Mean blood loss was 31.75±9.63 cc in the open group, 27.00±6.77 cc in the primary-closure group, and 35.25±7.86 cc in the semi-closed group. Pairwise analysis showed significantly lower blood loss with primary closure than with semi-closed surgery (P=0.002); differences between open surgery and primary closure (P=0.089) and between open and semi-closed surgery (P=0.166) were not statistically significant. Infection patterns varied descriptively among groups, but the chi-square analysis found no statistically significant association between surgical method and infection (χ²=8.743, df=6, P=0.189). Two cases of recurrence occurred in the primary-closure group, while no recurrence was observed in the open or semi-closed groups. The study also reported that the longest healing time occurred in a patient treated by primary closure in association with wound infection and postoperative suture separation.

Conclusion

In this clinical trial, open surgery was associated with a significantly longer healing time than primary closure and semi-closed surgery. Primary closure had the lowest mean blood loss and significantly less bleeding than the semi-closed technique, but both recurrences observed during six months of follow-up occurred in the primary-closure group. No statistically significant association was found between surgical technique and infection, and postoperative pain did not differ significantly among the three techniques. Considering the recurrence observed after primary closure despite its shorter mean healing time and lower blood loss, the authors do not recommend primary closure for pilonidal sinus treatment. The findings suggest that the semi-closed technique may be safer than open surgery and primary closure.

Keywords: Surgical techniques; Semi-closed surgery; Pilonidal sinus

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