Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a randomised multi-centre cost effectiveness study
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Objective / research question
Comparison of treatment related morbidity and cost-effectiveness in early stage endometrial cancer patients treated by laparoscopy (total laparoscopic hysterectomy and bilateral salpingo-oophorectomy (TLH+BSO)) versus laparotomy (the standard approach by total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH+BSO) through a vertical abdominal midline incision).
A multi-centre prospective randomized clinical phase 3 trial.
Study population / datasets
Before participating in the study, an experienced visiting laparoscopist supervised the gynaecologist while performing the TLH and scored the technical skills after each procedure using OSATS (Objective Structured Assessment of Technical Skills). If the competence score of 28 points is reached, evaluated at two independent procedures, the gynaecologist will be allowed to participate in the study.
Inclusion criteria:Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade 1 or 2, clinically stage I disease, negative endocervical curettage), signed written consent, age 18 years and older.
Exclusion criteria: other histological types than grade 1 or 2 endometrioid adenocarcinoma, clinically advanced disease (stage II to IV), uterine size larger than 10 weeks gestation and cardio pulmonary contra indications for laparoscopy.
Laparoscopy: TLH+BSO compared to the standard approach by laparotomy, TAH+BSO through a vertical abdominal midline incision.
The primary outcome is the rate of major complications, being an indicator of clinically relevant treatment related morbidity.
Secondary outcome measures are:
1) Costs and cost-effectiveness. Costs will be assessed by a cost assessment in which all preoperative as well as postoperative costs will be included.
2) Minor complications.Outcomes will be assessed by analyzing the CRF. An independent clinical review panel will differentiate between major and minor complications, blinded for treatment arm.
3) Quality of life (SF-36 and EUROQOL), sexual functioning (SAQ Sexual Activity Questionnaire), body image (BIS Body Image Scale) and VAS pain (Visual Analogue Scale).
Group sample sizes of 161 and 81 achieve 80% power to detect a difference of 0.15 between the null hypothesis that the major complication rate is 25% in both the laparotomy and the laparoscopy group and the alternative hypothesis that we will observe a complication rate of 25% in the laparotomy group and of 10% in the laparoscopy group, using a two-sided Chi-square test with continuity correction and with a significance level of 0.05. Assuming a drop-out percentage of at least 10%, 275 patients are needed.
In the economic evaluation costs of both interventions will be compared in a cost-effectiveness analysis. This analysis will assess the costs per major complication-free patient. The economic evaluation will be conducted from a societal perspective including direct medical and direct non-medical costs. Time horizon of the cost-effectiveness analysis will be 3 months, therefore discounting will not be applied. A sensitivity analysis will be conducted to estimate the impact of variation of major cost elements.
First year: start of study in all participating centers.
First 30 months: inclusion of patients, data collection and entry.
Last 6 months: analysis of data, preparation of manuscripts.
Dr. M.J.E. Mourits gynaecologist UMC Groningen
Drs. C.B.M. Bijen, UMC Groningen
Dr. G.H. de Bock, epidemiologist UMC Groningen
ZonMw - www.zonmw.nl