Vaginal Cuff Thermal Injury by Mode of Colpotomy at Total Laparoscopic Hysterectomy: A Randomized Clinical Trial

Study Objective: To evaluate if the use of Valleylab mode ("V mode") (Covidien, Mansfield, MA) electrothermal energy for colpotomy during total laparoscopic hysterectomy (LH) results in a smaller margin of thermal injury to the upper vagina compared with traditional cut/coagulate (cut/coag) electrothermal energy. Design: Prospective randomized clinical trial (Canadian Task Force classification I). Setting: University medical center. Patients: A total of 101 subjects who underwent LH between June 2010 and August2012. Interventions: Subjects were randomized to colpotomy by V mode electrothermal energy or cut/coag electrothermal energy. Measurements and Main Results: The primary end point was the median depth of thermal injury measured in millimeters. The secondary end points included the proportion of subjects who developed granulation tissue, induration, infection, or dehiscence at the vaginal cuff at 4weeks, 3months, or 6months postoperatively. There was no significant difference in the median depth of thermal injury in the cut/coag and V mode arms (anterior margin: 0.68mm vs 0.63mm [p=.94], posterior margin: 0.66mm vs 0.70mm [p=.87], respectively). Twenty-seven percent of subjects in each arm developed at least 1 of the clinical end points at 4weeks, 3months, or 6months postoperatively (granulation tissue: 6%-18% vs 8%-21%, induration: 0%-2% vs 4%-5%, infection: 0%-4% vs 0%-10%, dehiscence: 2% vs 0% in the cut/coag and V mode arms, respectively), with no difference between arms (p=1.0). Conclusion: The V mode does not reduce the depth of thermal injury compared with cut/coag electrothermal energy when used for colpotomy incision during total laparoscopic hysterectomy (Clinical Trials.gov ID: NCT02080546).