Enteral resorbable diet versus standard diet in primary sphincter reconstruction: a prospective randomised trial.

ABSTRACT

AIM: Bowel movements after reconstructive anorectal surgery may negatively affect surgical outcome. This study was aimed to assess any differences between a standard diet (SD) and the enteral resorbable diet (ED) in terms of operative outcomes and patient tolerance after fistulectomy with primary sphincter reconstruction. METHOD: Adult patients undergoing elective fistulectomy with primary sphincter reconstruction for anorectal and rectovaginal fistulas were eligible for inclusion. Patients were intraoperatively randomised to receive either the ED and peristalsis-inhibiting medication (ED) or a SD. The primary endpoint was the healing rate. Secondary endpoints included continence scores, complications and quality of life. Sample size calculation resulted in the analysis of 60 patients to detect a difference in fistula recurrence of 30% with 70% power and a 5% significance level. RESULTS: Sixty-six patients (24 women) were prospectively and randomly assigned to the ED (n = 34 51%) or a SD (n = 32; 48%); mean age was 47 (18-74) years. The primary healing rate was 64 out of 66 patients (96%). No statistical difference in healing rate was seen between the groups. However, patient satisfaction was significantly higher in the SD group (P < 0.0001). CONCLUSIONS: Fistulectomy with primary sphincter reconstruction is a safe method with low complication rates. Postoperative stool behaviour has no significant influence on the healing rate but has a significant negative impact on patient satisfaction. Therefore, maintaining a standard diet seems to be preferable following reconstructive anal surgery. TRIAL REGISTRATION The trial was registered with the German Clinical Trials Register ( DRKS00020524 ).