Dimensional versus standard 2-D laparoscopy for benign hysterectomy: A randomized clinical trial

Objective: Our aim was to evaluate possible short and long-term benefits of 3-dimensional (3-D) compared to 2-dimensional (2-D) laparoscopy for benign hysterectomy. Primary outcomes were long-term quality of life and postoperative pain. Secondary outcomes were operative time, surgical complications, time to return to work and length of hospitalization. Study design: A randomized controlled trial conducted at two Danish university hospitals. In each arm, 190 patients were needed for an alpha of 3.3 % and a power of 90 %. For various reasons, however, the study was prematurely terminated after including 97 patients. Patients were randomized to either 2-D (n = 48) or 3-D (n = 49) laparoscopy. A laparoscopic hysterectomy was performed. Quality of life was assessed by the Short Form Health Survey 36 (SF-36) questionnaire at the time of inclusion and 6 weeks postoperatively. Postoperative pain was assessed using a Numeric Rating Scale (NRS) and by monitoring the amount of analgesic consumption. Results: Out of the 97 randomized patients, 77 patients completed both SF-36 questionnaires. No significant differences in mental (p = 0.5) and physical status (p = 0.9) were found. The 2-D group had significantly higher pain-score registered in the post anesthesia care unit (PACU) (p = 0.004) and higher consumption of oral morphine equivalent dose (MEqD) (p = 0.003) than the 3-D group. This regardless a higher rate of minilaparotomies in the 2D (n = 7) than in the 3D (n = 1) group (p < 0.03). The 2-D group had also higher rate of Clavien-Dindo 2 (CD2) (n = 2) and Clavien-Dindo 3 (CD3) complications (n = 3) (p = 0.03) than 3-D (n = 0). The other secondary outcome parameters did not vary between groups. Conclusions: The results are severely hampered by the premature termination of the study, as less than 25 percent of the patients were recruited. Thus, no firm conclusions can be drawn regarding the quality of life and many of the secondary outcomes, as the lack of difference may be attributed to a type 2 error. However, the significant differences in postoperative pain and in complication rates suggest a greater advantage of 3-D laparoscopy than originally expected. Despite the methodological problems, the current data deserve attention in a sparsely investigated field, emphasizing the urgent need for further studies.