Laparoscopic Approach to Cancer of the Endometrium

Summary

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively for women with apparent Stage 1 endometrial cancer, comparing patients who are randomised to receive Total Laparoscopic Hysterectomy (TLH) and patients who are randomised to receive Total Abdominal Hysterectomy (TAH).

Conditions

• Endometrial Cancer

Interventions

PROCEDURE

Total Abdominal Hysterectomy

For patients with clinical stage I disease, removal of the uterus and both tubes and ovaries are considered current standard treatment in Australia.

PROCEDURE

Total Laparoscopic Hysterectomy

The technique of total laparoscopic hysterectomy (TLH), utilising the McCartney tube, has been developed by Anthony J. McCartney over the last 10 years. It allows the completion of the hysterectomy entirely laparoscopically, without the need for additional vaginal surgery.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  collaborator INDUSTRY

• Tyco Healthcare Group

  collaborator INDUSTRY

• Gynetech

  collaborator INDUSTRY

• Queensland Government - Smart Health Research Grant

  collaborator UNKNOWN

• National Health and Medical Research Council, Australia

  collaborator OTHER

• Cancer Council Queensland

  collaborator OTHER

• Cancer Council New South Wales

  collaborator OTHER

• Cancer Council Victoria

  collaborator OTHER

• Cancer Council Western Australia

  collaborator UNKNOWN

• Cancer Australia

  collaborator OTHER

• Queensland Centre for Gynaecological Cancer

  lead OTHER_GOV

Principal Investigators

• Andreas Obermair · Queensland Centre for Gynaecological Cancer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2016-04-30

Completion

2018-12-31

Countries

• Australia
• Hong Kong
• New Zealand
• United Kingdom

Study Locations