Postoperative pain following laser fistula closure versus ligation of the intersphincteric fistula tract: A prospective double-blinded randomized controlled trial.

BACKGROUND

Prior studies focus primarily on surgical outcomes of anal fistula treatment, such as healing rates, rather than patient-reported outcomes, such as postoperative pain, which could influence surgical choice.

OBJECTIVE

To compare pain scores at 6 and 24 h postoperatively between laser closure and ligation of the intersphincteric tract for anal fistula.

DESIGN

Prospective, double-blinded randomized controlled trial.

SETTINGS: A quaternary hospital in Malaysia.

PATIENTS: Patients aged 18-75 years with high transsphincteric fistulas.

INTERVENTION: Fistula laser closure versus ligation of the fistula tract (LIFT) treatment.

MAIN OUTCOME MEASURES: Pain scores, continence, quality of life (QOL), operative time, and treatment failure were compared using chi-square, Fisher's exact test, student t-test, or Mann-Whitney with p < 0.05 denoting statistical significance.

RESULTS

Fifty-six patients were recruited (laser, n = 28, LIFT, n = 28). Median pain scores for laser versus LIFT at 6 h postoperatively were 1.0 versus 2.0 (Rest, p = 0.213) and 3.0 versus 4.0 (Movement, p = 0.448), respectively. At 24 h, this reduced to 2.5 in both arms at rest (p = 0.842) but increased to 4.8 versus 3.5 on movement (p = 0.383). Median operative time for laser was significantly shorter (32.5 min) than LIFT (p < 0.001). Laser treated patients trended toward quicker return to work (10.5 vs. 14.0, p = 0.181) but treatment failure was similar (54% vs. 50%, p = 0.71). No patients developed postoperative incontinence. Mean SF-36 scores increased from baseline (67.1 ± 17.0; 95% CI 63.6-82.4 vs. 71.3 ± 11.4; 95% CI 64.0-75.0) to 6 months postoperatively (77.7 ± 21.0; 95% CI 57.0-80.3 vs. 74.0 ± 14.3; 95% CI 67.6-81.4) regardless of the type of surgery (P > 0.05).

LIMITATIONS: Patients with prior fistula surgery (approximately 20%) led to heterogeneity. The total laser energy delivered varied depending on fistula anatomy.

CONCLUSION

Laser fistula closure is an alternative to LIFT, with similar postoperative pain and shorter operative time despite more complex fistula anatomy in the laser arm, with a greater improvement in QOL.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT06212739.