Stimulated gracilis neosphincter operation. Initial experience, pitfalls, and complications.

PURPOSE: The stimulated gracilis neosphincter is accepted as a viable option in select patients with fecal incontinence. The aim of this study was to review the initial problems and complications. METHODS: A prospective analysis of all patients who underwent this procedure was undertaken. Stage I consisted of the distal vascular delay of the muscle and creation of a temporary stoma. Stage II was the transposition of the muscle and implantation of the stimulator and electrodes. Low frequency electrical stimulation was applied to the muscle for 12 weeks, after which Stage III (stoma closure) was undertaken. RESULTS: From March 1993 to December 1995, 17 patients (9 females and 8 males) with a mean age of 42.2 (range, 19-72) years underwent the procedure. One patient died from pancreatitis and another from small-bowel adenocarcinoma, three and six months after the procedure, respectively. Two patients (one with Crohn's disease) required permanent stomas. One additional patient required a permanent stoma because of lead fibrosis. Other complications noted during ascent of the learning curve included seroma of the thigh incision, excoriation of the skin above the stimulator, fecal impaction, anal fissure, parastomal hernia, rotation of the stimulator, premature battery discharge, fracture of the lead, perineal skin irritation, perineal sepsis, rupture of the tendon, tendon erosion, muscle fatigue during programming sessions, and electrode displacement from the nerve or fibrosis around the nerve. However, ultimately after rectification of these problems, 13 of the 15 eligible patients had stoma reversal. Manometric results showed an average basal pressure of 43 mmHg and an average maximum squeeze pressure that increased from 36 mmHg before surgery to 145 mmHg by stimulation (P < 0.01). Based on objective functional questionnaires, 9 of 15 (60 percent) evaluable patients reported improvement in continence, social interactions, and quality of life. Three of these nine patients require daily use of enemas. CONCLUSION: Although the stimulated gracilis operation is a feasible procedure for selected patients with severe incontinence, the learning curve is steep. Although the ultimate outcome in a selected group of patients can be very gratifying, major technical modifications are required before use beyond a research protocol setting. Furthermore, patients must have the psychological strength, emotional commitment, and financial resources that may be necessary for multiple revisional surgeries or ultimate device failure.