Endometrioid adenocarcinoma grade 1, or 2, clinically stage I disease, negative endocervical curettage or -biopsy
Conditions
Interventions
Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision.
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
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; 3. Age 18 years and older.
Exclusion criteria
Exclusion criteria: 1. Other histological types than grade 1 or 2 endometrioid adenocarcinoma; 2. Clinically advanced disease (stage II to IV); 3. Uterine size larger than 10 weeks gestation; 4. Cardio pulmonary contra indications for laparoscopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 major complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Costs and cost-effectiveness; 2. Minor complications; 3. Quality of life, sexual functioning, body image and VAS pain. | — |
Contacts
Public ContactClaudia B.M. Bijen
University Medical Center Groningen (UMCG), Department of Gynaecology, Hanzeplein 1
Outcome results
None listed