Minilaparoscopic Total Hysterectomy in Current Practice Feasibility and Benefits: A Unicentric, Randomized Controlled Trial

Abstract

To investigate whether mini-instrumentation may be used for hysterectomy (HT) by all surgeons (assistants and seniors) without increasing the operative time or altering surgeon working conditions. A unicenter, randomized controlled, single blind, parallel, noninferiority trial comparing 2 surgical techniques. A tertiary referral center. Thirty-two patients undergoing HT for a benign gynecologic disease were enrolled in this study in our center between April 2, 2015, and June 1, 2018. Sixteen patients were randomized in group A and 16 patients in group B. HT with bilateral annexectomy or ovarian conservation using 3-mm instruments (group A) or conventional 5-mm instruments (group B). Concerning the primary outcome, the operative time for the HT 3-mm group was 128 minutes (range, 122-150 minutes) versus 111 minutes (range, 92-143 minutes) for the HT 5-mm group (i.e., δ = 17 [90% confidence interval, -6 to 39]), with rejection of the noninferiority threshold at 35 minutes. Thirty-one percent of HTs initially performed using 3-mm instruments were completed with conventional instruments. HTs performed with mini-instruments required more concentration (p = .02) with surgeons reporting higher levels of frustration (p = .009) and sense of failure (p = .006). Patients tend to experience greater satisfaction regarding scars with a significant difference noted during the postoperative visit both for scar pain (1 vs 4 patients with moderate pain [30-50 mm on the Patient Scar Assessment Scale) in the HT 3-mm group and the HT 5-mm group, respectively) and scar firmness (p = .021; 3 vs 7 patients with moderate firmness [30-50 mm on the Patient Scar Assessment Scale] in the HT 3-mm group and the HT 5-mm group, respectively). Total minilaparoscopic HT appears inferior to standard laparoscopy in terms of operative time and surgeon working conditions; only the short-term cosmetic appearance was in favor of the 3-mm approach.