Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.

Objective: 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). Study design: A multicentre prospective randomized clinical phase 3 trial (RCT) (including at least 15 centres). After inclusion and informed consent 275 patients will be randomized to laparoscopy or laparotomy (2:1). Standardized care regarding anticoagulants and antibiotics is provided. The gynecologist will record outcomes on a structured case record form (CRF). These CRF's will be checked by the research nurse afterwards. Patients will be asked to fill in questionnaires pre-operatively, after 6 weeks, 3 and 6 months. Study population: Inclusion criteria: Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade 1 or 2, clinically stage I disease, negative endocervical curettage or biopsy), signed written informed consent, age 18 years and older. Before participating in the study of each participating gynecologist the laparoscopic skills in performing a TLH will be assessed by an experienced visiting gynecologist using a structured evaluation form. Only gynecologists with a sufficient score (>= 28 points) on an OSATS (Objective Structured Assessment of Technical Skills) form will be allowed to participate.
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. Intervention: Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision. Outcome measures: Our main 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 2) Minor complications. 3) Quality of life.

The laparoscopic approach is a cost-effective and safe alternative to laparotomy in early stage endometrial cancer patients with less major complications in the laparoscopy group.

Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision.