No registrations found.
ID
Source
Brief title
Health condition
Endometrioid adenocarcinoma grade 1, or 2, clinically stage I disease, negative endocervical curettage or -biopsy
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
1. Costs and cost-effectiveness;
2. Minor complications;
3. Quality of life, sexual functioning, body image and VAS pain.
Background summary
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.
Study objective
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.
Intervention
Laparoscopy (TLH+BSO) compared to the standard approach by laparotomy (TAH+BSO) through a vertical abdominal midline incision.
Hanzeplein 1
Claudia B.M. Bijen
Groningen 9700 RB
The Netherlands
+31 (0)50 3611528
c.b.m.bijen@og.umcg.nl
Hanzeplein 1
Claudia B.M. Bijen
Groningen 9700 RB
The Netherlands
+31 (0)50 3611528
c.b.m.bijen@og.umcg.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL808 |
| NTR-old | NTR821 |
| Other | : N/A |
| ISRCTN | ISRCTN49542560 |