Background: Although the ligation of the intersphincteric fistula tract is a promising anal sphincter-saving procedure for fistula-in-ano, the objective assessment of the sphincter preservation remains unknown.
Objective: The primary end point was to measure the anal function before and after this procedure. The secondary end point measured was cure of the disease.
Design: This study is a prospective observational study.
Setting: This study was conducted at the Department of Surgery, Kameda Medical Center, Japan, from March 2010 to August 2012.
Patients: Twenty patients with transsphincteric or complex fistulas were evaluated.
Interventions: All patients underwent the ligation of the intersphincteric fistula tract with a loose seton for anal fistulas.
Main outcome measures: Anal manometric study was performed before and 3 months after the procedure. Fecal incontinence was evaluated by using the fecal incontinence severity index. Failure was defined as nonhealing of the surgical wound or fistula.
Results: The median operation time was 42 minutes. No intraoperative complications were documented. The median follow-up duration was 18 (3-32) months. No patients reported any incontinence postoperatively. The median score of the fecal incontinence severity index before and 3 months after the procedure was 0. The median maximum resting pressure measured before and after operation were 125 (71-175) cm H2O and 133 (95-169) cm H2O. The median maximum squeeze pressure measured before and after operation were 390 (170-815) cm H2O and 432 (200-902) cm H2O. There were no significant postoperative changes in either the resting pressure or the squeeze pressure. Primary healing was observed in 19 (95%) patients, and the median healing time was 7 weeks; 1 wound remained incompletely healed.
Limitations: Short-term follow-up may not justify the use of the term definitive cure.
Conclusion: The ligation of the intersphincteric fistula tract with a loose seton showed no postoperative deterioration on anal sphincter function with favorable healing rates.