Sphinkeeper Procedure for Treating Severe Faecal Incontinence-A Prospective Cohort Study

Area of Science:

• Colorectal Surgery
• Gastroenterology
• Medical Devices

Background:

• Faecal incontinence (FI) significantly impacts quality of life.
• Novel surgical interventions are needed for refractory FI.
• Limited data exists on the efficacy of Sphinkeeper implantation for FI.

Purpose of the Study:

• To assess the functional outcomes and quality of life in patients undergoing Sphinkeeper surgery for refractory FI.
• To evaluate the safety and complication rates associated with the Sphinkeeper procedure.
• To investigate the incidence and patterns of prosthesis migration post-implantation.

Main Methods:

• A cohort of eleven consecutive patients with FI underwent Sphinkeeper implantation between 2018 and 2020.
• Functional outcomes and quality of life were assessed using standard questionnaires pre- and post-surgery.
• Prosthesis migration was evaluated using 3D endoanal ultrasound with a median follow-up of eight months.

Main Results:

• The median St. Mark's incontinence score significantly decreased from 22 to 13 (p = 0.008).
• Quality of life, measured by SF-12, showed significant improvement post-surgery (35.9 vs. 46.3, p = 0.028).
• Prosthesis migration occurred in 91% of patients, with 60% showing stable positioning.

Conclusions:

• Sphinkeeper implantation is a promising surgical option for severe fecal incontinence.
• The procedure demonstrates a low complication rate and achieves short-term functional improvement.
• Implant migration is a common occurrence but does not preclude positive outcomes.