Evaluation of new surgical technique in gynaecology. Randomised trials comparing laparoscopic and abdominal hysterectomy

The methodology of clinical trials has advanced considerably in the last 40 years, largely through the processes of pharmaceutical development. There has not been the same structured development in evaluating different surgical techniques. Most importantly, there is an unveiling scarcity of randomised trials comparing new surgical technique with conventional methods. The aim of this thesis was to test the efficacy of a new surgical technique, laparoscopic hysterectomy (LH) and compare it with the conventional surgical technique, abdominal hysterectomy (AH). Women scheduled for AH owing to benign disorders, with a maximum width of the uterus of less than 10 cm as measured by transvaginal ultrasound and not considered suitable for vaginal hysterectomy, were included. To compare short-term clinical results, 143 women were consecutively randomised to undergo the procedure by LH or AH. The degree of tissue trauma during and after surgery was analysed. Interleukin 6, cortisol, C-reactive protein, polymorphonuclear elastase and the terminal C5b-9 complement complex were determined. Pain and pulmonary function after surgery were analysed in patients who were given the opportunity to self-administer analgesics by the means of a programmable infusion pump containing morphine. Postoperative pain was evaluated using a visual analogue scale. Pulmonary function was assessed using a peak flow meter measuring peak expiratory flow and a vitalograph measuring forced vital capacity and forced expiratory volume in one second. Postoperative health status was assessed using The Medical Outcome Trust 36-Item Short-Form Health Survey questionnaire. The financial accounting system at the hospital and information from the local National Insurance Office were used for the economic analysis. The changes in direct costs (hospital costs) and indirect costs (loss of production value) when performing a LH instead of an AH were evaluated. Psychological well-being and sexuality were evaluated by questionnaires given to the patients before and one year after surgery. To evaluate psychological well-being, the Psychological General Well-Being Index (PGWB) was used. McCoy¥s sex scale questionnaire was used to measure changes in sexuality. The number of women with a complication did not differ significantly between the LH (27%) and AH (33%) groups. Although LH took longer (148 min vs 85 min, median value, P<0.001), the women undergoing this procedure had a shorter postoperative time in hospital (two vs four days, median value, P< 0.001) and a shorter convalescence (16 vs 35 days, median value, P< 0.001). None of the parameters used to assess surgical trauma differed significantly between the LH and AH groups. Pain scores were significantly lower after LH on the first and second postoperative day. The patients undergoing LH had significantly less impairment of lung function the first and second postoperative day compared to the patients undergoing AH. Postoperative health status improved significantly faster after LH than after AH. The direct costs were 2.6% higher, and the indirect costs were 50.3% lower for patients undergoing laparoscopic surgery. The total costs were 20.1% lower after LH. There were no significant differences when evaluating psychological well-being and sexuality one year after surgery between the LH and AH groups. It has been possible to answer several of the questions that were raised after the introduction of LH. The total complication rate was similar in both groups compared. The psychosexual well-being of the women was not dependent on the surgical approach. A similar level of stress response was found comparing the to surgical techniques. Outcomes such as shorter hospital stay and convalescence are dependent on other factors than the degree of surgical trauma. Less postoperative pain, less impact on pulmonary function and better ratings in quality of life questionnaires following LH in comparison with AH are in line with and can explain the shorter hospital stay and convalescence after LH. Although laparoscopic surgery takes longer to perform, the shorter hospital stay and convalescence implies substantial economic benefits for the patient and society