A Prospective Trial of the THD SphinKeeper® for Faecal Incontinence.

Aim THD SphinKeeper (R) is an emerging surgical technique for faecal incontinence (FI). The safety, indications and efficacy of the procedure are still being investigated. The aim of this study is to present the first experience of SphinKeeper (R) in Australia. Method This was a prospective single-centre observational study of patients undergoing SphinKeeper (R) implantation between February 2018 and September 2019. Baseline demographics, intraoperative and postoperative complications, Cleveland Clinic Faecal Incontinence Score, St Mark's Incontinence Score, Faecal Incontinence Quality of Life score (FIQOL), anorectal manometry and endo-anal ultrasound were assessed preoperatively and 3 and 12 months after implantation. Results Thirteen patients (2 male, 11 female) underwent implantation during the study period. Anal sphincter defects were present in 13 (76.9%) patients [external anal sphincter (EAS) defect, 2 (15.4%); internal anal sphincter (IAS) defect 4 (30.8%); EAS + IAS defect, 4 (30.8%)]. Median follow-up was 32 months (range 18-37 months). There were four complications: one intraoperative (rectal perforation) and three postoperative (one implant extrusion, two implants that required removal due to malposition). At 12 months, an average of 9/10 implants remained ideally placed in each patient. THD SphinKeeper (R) insertion was associated with an improvement in coping/behaviour as measured using FIQOL (p = 0.047). However, the procedure did not improve FI scores or anorectal manometry parameters. Conclusion In this study, SphinKeeper (R) marginally improved symptoms of FI but there was no significant impact on anorectal manometric measurements. Larger-scale studies are needed to determine the patient cohort most likely to benefit from this procedure.