aparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multi-centre cost-effectiveness study.
Completed
- Conditions
- Endometrioid adenocarcinoma grade 1, or 2, clinically stage I disease, negative endocervical curettage or -biopsy
- Registration Number
- NL-OMON22764
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 275
Inclusion Criteria
1. Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade 1 or 2, clinically stage I disease, negative endocervical curettage);
2. Signed written informed consent;
Exclusion Criteria
1. Other histological types than grade 1 or 2 endometrioid adenocarcinoma;
2. Clinically advanced disease (stage II to IV);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Our main outcome is the rate of major complications, being an indicator of clinically relevant treatment related morbidity. Major complications considered are: injuries of bowel, bladder, ureter, vessel, nerves; thrombo-embolic events such as deep venous thrombosis or pulmonary embolism; haematoma requiring surgical intervention; haemorrhage requiring transfusion and/or surgical intervention; wound dehiscence requiring surgical intervention or re-admission; wound infections including vaginal vault abscess, requiring surgical intervention and/or prolonged hospital stay and/or readmission and/or treatment; other<br>major complications.
- Secondary Outcome Measures
Name Time Method 1. Costs and cost-effectiveness;<br>2. Minor complications;<br>3. Quality of life, sexual functioning, body image and VAS pain.