Complications of dynamic graciloplasty - Incidence, management, and impacton outcome

PURPOSE: Dynamic graciloplasty can improve continence in patients with seve re refractory fecal incontinence, but associated morbidity is high. The pur pose of this study was to identify complications associated with dynamic gr aciloplasty and to characterize their treatment and impact on patient outco me. METHODS: In 121 patients enrolled in a prospective trial of 20 centers and eligible for safety analysis, all complications of dynamic graciloplast y were recorded at the time of their occurrence and followed up until resol ution. Severe treatment-related complications were defined as those requiri ng hospitalization or surgical intervention. RESULTS: In 93 patients, 211 c omplications occurred. Of these, 89 (42 percent) in 61 patients were classi fied as severe treatment-related complications and resulted from the follow ing: major infection, 19; minor infection, 10; thromboembolic events, 3; de vice performance and use, 13; pain, 16; noninfectious gracilis problems, 8; noninfectious wound-healing problems, 3; other surgery-related complicatio ns, 3. In addition, severe treatment-related complications resulted from co nstipation in ten and stoma creation or closure in ten. The recovery rate ( full or partial) was 87 percent overall, and for severe treatment-related c omplications, was 92 percent. Of the types of complications, only major inf ections had an adverse effect on outcome. CONCLUSION: Severe complications occur frequently after dynamic graciloplasty, but are usually treatable. Th ey often require one or more reoperations and can lead to significant delay s in completion of therapy. In most cases therapy can be salvaged.