Contact information
Type
Scientific
Primary contact
Dr Claudia B M Bijen
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Department of Gynaecology
Hanzeplein 1
Groningen
9700 RB
Netherlands
+31 (0)50 361 1528
c.b.m.bijen@og.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TLH-RCT
Study hypothesis
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.
Ethics approval
Approval received from the Medical Ethical Committee of the University Medical Center Groningen on the 31st May 2006 (ref: M06..38223).
Study design
Randomised controlled, parallel group, single blinded, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Endometrial carcinoma
Intervention
Laparoscopy (Total Laparoscopic Hysterectomy [TLH] and Bilateral Salpingo-Oophorectomy [BSO]) compared to the standard approach by laparotomy (Total Abdominal Hysterectomy [TAH] and BSO) through a vertical abdominal midline incision.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Our main outcome is the rate of major complications, being an indicator of clinically relevant treatment related morbidity. Major complications considered are:
1. Injuries of bowel, bladder, ureter, vessel, nerves
2. Thrombo-embolic events such as deep venous thrombosis or pulmonary embolism
3. Haematoma requiring surgical intervention
4. Haemorrhage requiring transfusion and/or surgical intervention
5. Wound dehiscence requiring surgical intervention or re-admission
6. Wound infections including vaginal vault abscess, requiring surgical intervention and/or prolonged hospital stay and/or readmission and/or treatment
7. Other major complications
Secondary outcome measures
1. Costs and cost-effectiveness
2. Minor complications
3. Quality of life, sexual functioning, body image and Visual Analogue Scale (VAS) pain
Overall trial start date
01/01/2007
Overall trial end date
01/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with early stage endometrial cancer (endometrioid adenocarcinoma grade one or two, clinically stage I disease, negative endocervical curettage)
2. Signed written informed consent
3. Age 18 years and older
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
275
Participant exclusion criteria
1. Other histological types than grade one or two endometrioid adenocarcinoma
2. Clinically advanced disease (stage II to IV)
3. Uterine size larger than ten weeks gestation
4. Cardio pulmonary contra indications for laparoscopy
Recruitment start date
01/01/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary