A prospective, noncomparative, study to evaluate the efficacy and safety of sphincter saving distal laser proximal ligation surgery in complex fistula-in-ano

Abstract

Background: Distal laser proximal ligation technique (DLPL) is a minimally invasive sphincter-saving surgery which addresses the inter sphincteric space, which is the root cause of complex fistula. Objective: To evaluate efficacy and safety outcomes of new technique. Design: A prospective, noncomparative. Settings: A single-center study. Patients: Complex fistula-in-ano cases were included. Patients with uncomplicated fistula, inflammatory bowel disease, Chronic immunosuppressive treatment, and cancer were excluded. Interventions: Laser debridement of fistula tract by use of Radial Fiber with 1470 nm Diode laser at a power of 10W and proximal Ligation technique. Outcome Measures: Data were collected prospectively on effectiveness (disease severity, ODSscore, hospitalization, time to resume routine), safety (morbidity, adverse outcomes), Wexner incontinence score and quality of life score before surgery and after surgery at week 6, at 6 months and 12 months physically and thereafter telephonically for 2 years. Outcomes other than overall complete healing were considered as failure. Results: 683 patients underwent DLPL, predominantly male with a median age of 41.06 years (range, 11-86y). The overall success rate was 98.98%with a minimum long term follow-up period of 30 months. Complete healing time was average 10 weeks for most of the cases. No case reported permanent(major or minor) anal incontinence.The difference between quality of lifescore wasstatistically highly significant (p<0.001). Limitations: Single-institution and noncomparative data. Conclusion: DLPL is a minimally invasive, sphincter saving surgery for complex fistula.