3-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.

3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial.

BACKGROUND: Hysterectomy is one of the most common surgical procedures for women of reproductive age. Laparoscopy was introduced in the 1990es and is today one of the recommended routes of surgery. A recent observational study showed that operative time for hysterectomy was significantly lower for 3-dimensional compared to conventional laparoscopy. Complication rates were similar for the two groups. No other observational studies or randomized clinical trials have compared 3-dimensional to conventional laparoscopy in patients undergoing total hysterectomy for benign disease. The objective of the study is to determine if 3D laparoscopy gives better quality of life, less postoperative pain, less per- and postoperative complications, shorter operative time, or a shorter stay in hospital and a faster return to work or normal life, compared to conventional laparoscopy for benign hysterectomy. METHODS/DESIGN: The design is a randomised multicentre clinical trial. Participants will be 400 women referred for laparoscopic hysterectomy for benign indications. Patients will be randomized to 3-dimensional or conventional laparoscopic hysterectomy. Operative procedures will follow the same principles and the same standard whether the surgeon's vision is 3-dimensional or conventional laparoscopy. Primary outcomes will be the impact of surgery on quality of life, assessed by the SF 36 questionnaire, and postoperative pain, assessed by a Visual Analogue scale for pain measurement. With a standard deviation of 12 points on SF 36 questionnaire, a risk of type I error of 3.3% and a risk of type II error of 10% a sample size of 190 patients in each arm of the trial is needed. Secondarily, we will investigate operative time, time to return to work, length of hospital stay, and - and postoperative complications. DISCUSSION: This trial will be the first randomized clinical trial investigating the potential clinical benefits and harms of 3-dimensional compared to conventional laparoscopy. The results may provide more evidence regarding the future place of 3-dimensional laparoscopy in the range of endoscopic approaches for benign hysterectomy. TRIAL REGISTRATION: This study is registered at ClinicalTrial.gov: NCT02610985 November 16th 2015. November 2015. The regional Ethical committee approved it on the 12. November 2015, approval number: SJ-498. Data handling was approved by the Danish Data Protection Agency: REG-109-2015 on the 13. November 2015.

Laparoscopic surgery for early endometrial cancer.

INTRODUCTION: The purpose of the present study was to evaluate learning curves and short-term outcomes following laparoscopic surgery for early endometrial cancer in women of different body mass index (BMI) classes. MATERIAL AND METHODS: Data from 227 women planned for laparoscopic surgery for presumed stage I endometrial cancer were collected retrospectively from a Danish gynecologic oncology unit. Surgery included laparoscopic hysterectomy and bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy (PLA). RESULTS: Median length of operations was 60 min (range, 30-197) and 120 min (range, 60-230), depending on whether PLA was included. The median pelvic lymph node yield was 18 (range, 7-42). For staging with PLA there was a learning curve when measured as operative time as well as lymph node yield, and a level of proficiency was not reached after 40 operations. The women had a perioperative complication rate of 4.5% and a median hospital stay of one night. Postoperative complication rate was 12%, comprising vaginal cuff hematoma (3.1%), vaginal cuff rupture (0.9%), trocar hernia (1.3%), ureter lesion (0.4%), bowel lesion (0.4%), reoperation (0.9%) and other complications (4.5%). All peri- and postoperative outcomes were independent of BMI classes. CONCLUSIONS: Our data suggest that laparoscopic surgery for early endometrial cancer is feasible and safe. With increasing surgeon's experience there is a significant decrease in operative time and increase in the number of lymph nodes harvested. In experienced hands, either operative time, complications or length of stay are not affected by increasing BMI, even when women are morbidly obese.

Placenta percreta treated using a new surgical technique.

Placenta percreta is still a life threatening condition due to the risk of excessive bleeding. Furthermore, it confers a considerable risk of the patient losing her uterus. An improved diagnosis including assessment of the depth of myometrial and serosal invasion is now available by color Doppler imaging, making the planning of elective caesarean section possible. We have designed a new operating technique, by which we successfully have achieved haemostasis of the areas containing the uterine arteries as well as the area between the bladder and the uterine cervix.