A Randomized Controlled Trial Comparing Laser Versus Open Surgical Approaches in the Management of Fistula-in-Ano at...

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.

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.

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).

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.