Laparoscopy versus laparotomy in treatment of early stage endometrial cancer: a multicentre cost-effectiveness study

ISRCTN	ISRCTN49542560
DOI	https://doi.org/10.1186/ISRCTN49542560
Protocol serial number	NL808, NTR821
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled, parallel group, single blinded, multicentre trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	1. Costs and cost-effectiveness 2. Minor complications 3. Quality of life, sexual functioning, body image and Visual Analogue Scale (VAS) pain
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.