Comparative Assessment of Laser Destruction in Combination with Pit-Picking and Excision with Bascom II Flap Reconstruction in the Treatment of Pilonidal Sinus: Preliminary Results of a Multicenter Randomized Study

Aim: to assess the interim results of a prospective multicenter randomized study comparing laser destruction in combination with pit-picking and excision with Bascom II flap reconstruction in the treatment of pilonidal sinus.

Materials and methods. Patient recruitment was conducted from November 2022 to April 2024. The study included 62 patients (31 patients in each group): the first group underwent surgical excision of pilonidal cyst with Bascom II flap reconstruction, while the second group underwent laser destruction (LD) in combination with pit-picking. An interim analysis of the results was performed after half of the sample size was reached. The primary endpoint of the study was incidence of disease recurrence after surgical treatment. Secondary endpoints were: the severity of pain on days 1, 3, 5, 7, 10, 14, and 21 of the postoperative period; the quality of life of patients before surgery and 1, 3, and 6 months after surgery according to the SF-12 questionnaire (The 12-Item Short Form Survey); the frequency and nature of intraoperative complications; the frequency and nature of postoperative complications; complete postoperative wound healing, defined as full epithelialization and scar formation.

Results. Both groups were comparable in terms of gender, age, and body mass index. Surgery duration and blood loss were statistically significantly lower in the LD + pit-picking group (p < 0.001). The number of postoperative bed days was statistically significantly higher in the Bascom II group (p < 0.01). The visual analogue scale scores were statistically significantly higher in the Bascom II group on days 1–10 after surgery (p < 0.05). Postoperative wound healing with complete epithelialization occurred statistically significantly faster in the Bascom II group compared to the LD + pit-picking group — in 24 (16–33) and 35 (28–45) days, respectively (p = 0.002). The number of visits was statistically significantly lower in the Bascom II group (p < 0.001). Patients returned to daily physical activity after 14 (11–16) and 4 (3–4) days in the Bascom II and LD + pit-picking groups, respectively (p < 0.001). According  to SF-12, one month after surgery, the LD + pit-picking group showed better results in physical and mental health indicators (p < 0.001). Six months after surgery, the Bascom II group showed better results in both indicators (p < 0.001). The recurrence rate requiring repeat surgery was higher in the LD + pit-picking group — 0 vs. 5 (16.1 %) cases in the Bascom II group (p = 0.053).

Conclusions. Laser destruction combined with pit-picking demonstrates advantages in the form of a lower rate of early postoperative complications and faster recovery of physical activity in patients. However, this method is associated with prolonged outpatient follow-up and a higher recurrence rate compared to the Bascom II flap reconstruction.

1. Zagryadskiy E.A. Bascom II (Cleft-Lift) procedure for recurrent pilonidal sinus. Koloproktologia. 2018;2S:18–8a. (In Russ.)].

2. Harries R.L., Alqallaf A., Torkington J., Harding K.G. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019;16(2):370–8. DOI: 10.1111/iwj.13042

3. Iesalnieks I., Ommer A., Herold A., Doll D. German national guideline on the management of pilonidal disease: Update 2020. Langenbecks Arch Surg. 2021;406(8):2569– 80. DOI: 10.1007/s00423-020-02060-1

4. Stauffer V.K., Luedi M.M., Kauf P., Schmid M., Diekmann M., Wieferich K., et al. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018;8(1):3058. DOI: 10.1038/s41598-018-20143-4

5. Bascom J.U. Repeat pilonidal operations. Am J Surg. 1987;154(1):118–22. DOI: 10.1016/0002-9610(87)90300-x

6. Ojo D., Flashman K., Thomas G., Tozer P., Senapati A. Cleft closure (the Bascom cleft lift) for 714 patients-treatment of choice for complex and recurrent pilonidal disease (a cohort study). Colorectal Dis. 2023;25(9):1839–43. DOI: 10.1111/codi.16688

7. Immerman S.C. The Bascom cleft lift as a solution for all presentations of pilonidal disease. Cureus. 2021;13(2):e13053. DOI: 10.7759/cureus.13053

8. Immerman S.C. Patient satisfaction after the cleft-lift procedure. Cureus. 2021;13(9):e17686. DOI: 10.7759/cureus.17686

9. Sluckin T.C., Hazen S.J.A., Smeenk R.M., Schouten R. Sinus laser-assisted closure (SiLaC®) for pilonidal disease: Results of a multicentre cohort study. Tech Coloproctol. 2022;26(2):135–41. DOI: 10.1007/s10151-021-02550-4

10. Yardimci V.H. Outcomes of two treatments for uncomplicated pilonidal sinus disease: Karydakis flap procedure and sinus tract ablation procedure using a 1,470 nm diode laser combined with pit excision. Lasers Surg Med. 2020;52(9):848–54. DOI: 10.1002/lsm.23224

11. Iesalnieks I., Deimel S., Kienle K., Schlitt H.J., Zülke C. Pit-picking-Operation bei Patienten mit Sinus pilonidalis [Pit-picking surgery for pilonidal disease]. Chirurg. 2011;82(10):927–31. DOI: 10.1007/s00104-011-2077-9

12. Horesh N., Maman R., Zager Y., Anteby R., Weksler Y., Carter D., et al. Surgical outcomes of minimally invasive trephine surgery for pilonidal sinus disease with and without laser therapy: A comparative study. Tech Coloproctol. 2023;28(1):13. DOI: 10.1007/s10151-023-02897-w

13. Wang X., Ji X. Sample size estimation in clinical research: From randomized controlled trials to observational studies. Chest. 2020;158(1S):S12–20. DOI: 10.1016/j.chest.2020.03.010

14. Dessily M., Dziubeck M., Chahidi E., Simonelli V. The SiLaC procedure for pilonidal sinus disease: Long-term outcomes of a single institution prospective study. Tech Coloproctol. 2019;23(12):1133–40. DOI: 10.1007/s10151-019-02119-2

15. Romic I., Augustin G., Bogdanic B., Bruketa T., Moric T. Laser treatment of pilonidal disease: A systematic review. Lasers Med Sci. 2022;37(2):723–32. DOI: 10.1007/s10103-021-03379-x

16. Akyol H. Sinus laser therapy versus Karydakis flap procedure in the management of pilonidal sinus disease: A comparative analysis of intraoperative parameters and postoperative outcome. Tech Coloproctol. 2024;29(1):26. DOI: 10.1007/s10151-024-03058-3

17. Algazar M., Zaitoun M.A., Khalil O.H., Abdalla W.M. Sinus laser closure (SiLaC) versus Limberg flap in management of pilonidal disease: A short-term non-randomized comparative prospective study. Asian J Surg. 2022;45(1):179–83. DOI: 10.1016/j.asjsur.2021.04.026

18. Gips M., Melki Y., Salem L., Weil R., Sulkes J. Minimal surgery for pilonidal disease using trephines: Description of a new technique and long-term outcomes in 1,358 patients. Dis Colon Rectum. 2008;51(11):1656–63. DOI: 10.1007/s10350-008-9329-x