Randomized clinical trials from centers specializing in endoscopic surgery have reported that laparoscopic hysterectomy is associated with a shorter hospital stay, less discomfort, and a faster return to normal activities than standard abdominal hysterectomy. These studies have been criticized because they were based on small, selected populations. Studies comparing vaginal and laparoscopic hysterectomy techniques generally have shown comparable results but longer operating times for the laparoscopic approaches. Garry and colleagues used a large multicenter trial to compare the outcomes of the different techniques using two parallel randomized trials.
The 43 participating gynecologists in 30 centers in Britain and South Africa recruited more than 1,300 women who were scheduled to have hysterectomy for nonmalignant conditions. Participants were required to have no significant medical conditions and a uterine size less than 12 weeks’ gestation with no evidence of prolapse. Patients were randomly assigned to the abdominal or vaginal trial, then further randomized to laparoscopic or standard techniques.
Surgical procedures were performed as usual for the surgeon or center. Any conversion to an alternative technique was documented. Patients were monitored primarily for major complications while in the hospital and at a six-week clinic visit. Patient data also were gathered by postal questionnaire after four and 12 months. Secondary outcomes that were monitored included minor complications, pain (assessed by visual analog scale), analgesia use, sexual activity, body image, and general health status.
The women in the four treatment groups were well matched in all significant respects. In the abdominal trial, 292 women underwent standard hysterectomy, and 584 had a laparoscopic procedure. Abdominal laparoscopic hysterectomy took longer (median, 84 versus 50 minutes) to perform than abdominal hysterectomy. Similarly, vaginal hysterectomy took longer when laparoscopic techniques were used (72 versus 39 minutes).
Major complications occurred in 65 (11.1 percent) women in the laparoscopic group, which is significantly more than the 18 (6.2 percent) reported in the abdominal group. In the vaginal trial, the 168 women undergoing standard hysterectomy had 16 (9.5 percent) complications compared with 33 (9.8 percent) in the 336 women undergoing laparoscopic procedures (see accompanying table). The numbers of patients did not allow statistical conclusions to be drawn comparing vaginal techniques.
The rate of minor complications was comparable (27 versus 25 percent) in patients in the two abdominal surgery groups. It also was comparable in the two groups treated vaginally (27 versus 23 percent). Additional pathology—mainly adhesions, endometriosis, and fibroids—was twice as likely to be reported during laparoscopic surgeries in the abdominal and vaginal groups.
The median length of hospital stay after abdominal hysterectomy was one day longer than for laparoscopic abdominal procedures but identical in both vaginal groups. Abdominal hysterectomy was significantly more painful than abdominal laparoscopic hysterectomy, but pain scores did not differ in the vaginal trial. All procedures were associated with improvements in quality of life at four and 12 months. Early differences in the abdominal group (i.e., body image, sexual activity, and physical aspects of quality of life) versus the laparoscopic group resolved by 12 months.
The authors conclude that laparoscopic hysterectomy is associated with a significantly higher rate of major complications than abdominal hysterectomy and takes longer to perform. Conversely, laparoscopic abdominal hysterectomy results in better short-term quality of life, less pain, and more rapid return to normal activities. In the vaginal approach, the study did not include sufficient patients to support statistically significant conclusions.
In a related study, Sculpher and colleagues conducted a cost-effectiveness analysis of these clinical trials. They estimate that laparoscopy costs an average of $328 more than the abdominal procedure. Laparoscopy costs an average of $708 more than vaginal hysterectomy. In both groups, no significant difference in overall quality of life was achieved. These authors conclude that vaginal laparoscopic hysterectomy is not cost effective compared with standard techniques, but the two techniques are balanced in abdominal approaches.
|Abdominal trial||Vaginal trial|
|Abdominal hysterectomy (n = 292)||Laparoscopic hysterectomy (n = 584)||Vaginal hysterectomy (n = 168)||Laparoscopic hysterectomy (n = 336)|
|Major hemorrhage||7* (2.4)||27* (4.6)||5 (2.9)||17 (5.1)|
|Bowel injury||3 (1)||1 (0.2)||0||0|
|Ureteric injury||0||5 (0.9)||0||1 (0.3)|
|Bladder injury||3 (1)||12* (2.1)||2 (1.2)||3 (0.9)|
|Pulmonary embolus||2 (0.7)||1 (0.2)||0||2 (0.6)|
|Anesthesia problems||0||5* (0.9)||0||2 (0.6)|
|Intraoperative conversion||1† (0.3)||23 (3.9)||7 (4.2)||9 (2.7)|
|Return to theater||1 (0.3)||3 (0.5)||0||1 (0.3)|
|Wound dehiscence||1 (0.3)||1 (0.2)||0||1 (0.3)|
|Hematoma||2 (0.7)||4 (0.7)||2 (1.2)||7 (2.1)|
|Other complications||0||0 (0)||1 (0.6)||0 (0)|
|At least one major complication||18 (6.2)||65 (11.1)||16 (9.5)||33 (9.8)|