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

University Medical Center Groningen (UMCG)
Department of Gynaecology
Hanzeplein 1
Groningen
9700 RB
Netherlands

Phone +31 (0)50 361 1528
Email c.b.m.bijen@og.umcg.nl

Study information

Study designRandomised controlled, parallel group, single blinded, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleLaparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multicentre cost-effectiveness study
Study acronymTLH-RCT
Study objectivesThe 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) studiedEndometrial carcinoma
InterventionLaparoscopy (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 typeOther
Primary outcome measureOur 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 measures1. Costs and cost-effectiveness
2. Minor complications
3. Quality of life, sexual functioning, body image and Visual Analogue Scale (VAS) pain
Overall study start date01/01/2007
Completion date01/01/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
SexNot Specified
Target number of participants275
Total final enrolment279
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2007
Date of final enrolment01/01/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

P.O. Box 30001
Groningen
9700 RB
Netherlands

Website http://www.rug.nl/umcg/index?lang=en
ROR logo "ROR" 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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.