Condition category
Cancer
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
18/01/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.rug.nl/umcg/index?lang=en

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

Publication citations

Additional files

Editorial Notes