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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00604994




Registration number
NCT00604994
Ethics application status
Date submitted
13/01/2008
Date registered
30/01/2008
Date last updated
20/08/2013

Titles & IDs
Public title
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Scientific title
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
Secondary ID [1] 0 0
LEGS
Universal Trial Number (UTN)
Trial acronym
LEGS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female Genital Diseases 0 0
Ovarian Cancer 0 0
Cervical Cancer 0 0
Endometrial Cancer 0 0
Vulval Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Malignant - Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina

Benign - Patients without malignant gynaecological cancers
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time of onset of lymphoedema after gynaecological cancer treatment.
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Incidence of lymphoedema after gynaecological cancer treatment.
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
Point prevalence of lymphoedema after gynaecological cancer treatment.
Timepoint [3] 0 0
2 years
Primary outcome [4] 0 0
Severity of lymphoedema after gynaecological cancer treatment.
Timepoint [4] 0 0
2 years
Secondary outcome [1] 0 0
Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Impact of risk factors on development of lymphoedema.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.
Timepoint [3] 0 0
2 years

Eligibility
Key inclusion criteria
- Patients scheduled for surgery of benign or malignant gynaecological diseases as
determined jointly by the surgeon and the patient.

- Non-pregnant female patients.

- Over 18 years of age at time of surgery.

- Patients who understand the conditions of the study and are willing to participate for
the length of the prescribed term of follow-up.

- Patients who are capable of, and have given, informed consent to their participation
in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with a pacemaker.

- Allergies against adhesive electrodes and extensive internal metal plates are
ineligible for BIS measurement.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
761
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [6] 0 0
Royal Women's Hospital - Carlton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
3053 - Carlton

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Mater
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Mater Private Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Queensland Institute of Medical Research
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Queensland University of Technology
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Australia New Zealand Gynaecological Oncology Group
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Cancer Australia
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This project will conduct a prospective, longitudinal, observational cohort study to assess
the onset and incidence of lymphoedema, as well as investigate factors associated with its
development among women newly diagnosed with gynaecological cancers in 2008 to 2011.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00604994
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair, MD FRANZCOG CGO
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00604994