Abstract
BACKGROUND: Fistula-in-ano remains a challenging surgical entity due to its high recurrence rate and potential risk of incontinence. This study evaluates and compares the efficacy, safety, and patient-centered outcomes of laser surgery and open surgical procedures. METHODS: This prospective randomized controlled trial (RCT) (ClinicalTrials.gov identifier: NCT07083778) included 100 patients diagnosed with intersphincteric or transsphincteric fistula-in-ano at Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College, Kanpur, India. Patients were randomized using the even-odd method into two groups: open surgery (n=50) and laser surgery (n=50). Assessed parameters included operative time, postoperative pain (visual analog scale), hospital stay, return to daily activity, healing time, recurrence, incontinence (Wexner score), complications, and patient satisfaction. RESULTS: The laser group showed significant advantages in terms of postoperative pain, with 35 patients (70%) reporting only mild pain compared to 15 patients (30%) in the open surgery group (p<0.01). Hospital stay was shorter in the laser group (1.5 ± 0.5 days) compared to the open group (3.8 ± 1.2 days; p<0.001), and return to normal activity was quicker (4.96 ± 0.91 vs. 9.96 ± 0.74 days; p<0.001). However, open surgery demonstrated superior clinical outcomes. Complete healing at three months was achieved in 41 patients (82%) in the open group vs. 35 patients (70%) in the laser group (p=0.16). Recurrence was observed in 15 patients (30%) in the laser group and nine patients (18%) in the open group, approaching statistical significance (p=0.06). Wound infection occurred more frequently in the open group with eight cases (15%) compared to three cases (5%) in the laser group (p=0.034), though all were minor. Incontinence was reported in two patients (5%) and anal stenosis in one patient (2%), all within the open group. Reoperation was more commonly required in the laser group (15 patients, 30%) compared to the open group (nine patients, 18%). Overall, patient satisfaction was slightly higher in the open surgery group (mean score: 6.98 ± 1.96) than in the laser group (6.34 ± 2.29). CONCLUSION: While laser surgery offers faster recovery and reduced postoperative morbidity, open surgery remains the more definitive treatment option due to its superior long-term outcomes. Surgical decision-making should be individualized based on fistula complexity and patient-specific factors.