Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multicentre cost-effectiveness study
ISRCTN | ISRCTN49542560 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN49542560 |
Secondary identifying numbers | NL808, NTR821 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Claudia B M Bijen
Scientific
Scientific
University Medical Center Groningen (UMCG)
Department of Gynaecology
Hanzeplein 1
Groningen
9700 RB
Netherlands
Phone | +31 (0)50 361 1528 |
---|---|
c.b.m.bijen@og.umcg.nl |
Study information
Study design | Randomised controlled, parallel group, single blinded, multicentre trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multicentre cost-effectiveness study |
Study acronym | TLH-RCT |
Study objectives | 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(s) | Approval received from the Medical Ethical Committee of the University Medical Center Groningen on the 31st May 2006 (ref: M06..38223). |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/01/2007 |
Completion date | 01/01/2010 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 275 |
Total final enrolment | 279 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2007 |
Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 30001
Groningen
9700 RB
Netherlands
Website | http://www.rug.nl/umcg/index?lang=en |
---|---|
https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/04/2011 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.