Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000558628
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
29/09/2005
Date last updated
29/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double-blind trial evaluating preoperative medical treatment of endometriosis prior to radical laparoscopic excision of disease
Scientific title
A randomised, double-blind trial evaluating preoperative medical treatment of endometriosis prior to radical laparoscopic excision of disease to observe the effect on their post-operative outcome with regard to symptomatology, change in quality of life and the ease of completing the procedure and time taken for the procedure.
Universal Trial Number (UTN)
Trial acronym
not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 683 0
Condition category
Condition code
Reproductive Health and Childbirth 758 758 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Three months of the continuous oral contraceptive pill + placebo GnRH analogue
2. Three months of GnRH analogue + placebo pill
Intervention code [1] 605 0
Treatment: Drugs
Comparator / control treatment
3. Three months of placebo pill + placebo GnRH analogu
Control group
Placebo

Outcomes
Primary outcome [1] 951 0
To assess the effects of pre-treatment of women with endometriosis prior to radical laparoscopic excision of endometriosis compared to no treatment. Areas to be assessed include:
Effect on pain score as assessed by pain scores on a visual analogue scale
Timepoint [1] 951 0
Measured at baseline, surgery date and then at three monthly intervals for a 12 month period post operatively.
Primary outcome [2] 952 0
To assess the effects of pre-treatment of women with endometriosis prior to radical laparoscopic excision of endometriosis compared to no treatment. Areas to be assessed include:
Pain assessment by change using the McGill pain questionnaire
Timepoint [2] 952 0
Measured at baseline, surgery date and then at three monthly intervals for a 12 month period post operatively.
Primary outcome [3] 953 0
To assess the effects of pre-treatment of women with endometriosis prior to radical laparoscopic excision of endometriosis compared to no treatment. Areas to be assessed include:
Quality of life change assessed by the AQOL, SF12 and sexual activity questionnaires
Timepoint [3] 953 0
Measured at baseline, surgery date and then at three monthly intervals for a 12 month period post operatively.
Secondary outcome [1] 1820 0
To observe a difference in the clinical and quality of life outcomes if women are treated by the oral contraceptive pill, a GnRH analogue or placebo.
Timepoint [1] 1820 0
Secondary outcome [2] 1821 0
To observe any difference between groups at the time of surgery as regards to operative time, perceived surgical difficulty and blood loss.
Timepoint [2] 1821 0
Secondary outcome [3] 1822 0
To observe any difference in the post-operative analgesia requirements between groups.
Timepoint [3] 1822 0
Secondary outcome [4] 1823 0
To observe any difference in re-treatment or adjuvant treatment within one year of follow-up.
Timepoint [4] 1823 0

Eligibility
Key inclusion criteria
1.Women who are known to have or suspected to have endometriosis as a cause of their symptoms2. Women who are equally willing to comply with medication administration 3. Women who are able complete questionnaires relating to pain and quality of life4. Women who have histological confirmation of endometriosis at surgery5. Women with suspected endometriosis based on history, clinical examination and current or previous investigations including laparoscopic features of endometriosis would be eligible for entry to the study.
Minimum age
Not stated
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with a suspected diagnosis of gynaecological malignancy or its precursors2. Women with current or chronic pelvic inflammatory disease3. Women who are currently pregnant or not willing to use barrier contraception during the pre-operative period 4. Women who have a contra-indication to the use of oestrogens such as previous thrombo-embolic disease 5. Women who currently smoke and are over the age of 35 6. Women who have had a previous reaction, or contra-indication to the use of a GnRH analogue7. Women unable to give informed consent8. Women unable or unwilling to attend for a twelve month follow up visit.Note: Previous treatment for endometriosis is NOT an exclusion to trial participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be achieved by opening an opaque consecutively numbered envelope with the study allocation number identified on the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by computer-generated blocks in balanced groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
not applicable
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 839 0
Hospital
Name [1] 839 0
Department of EndoGynaecology Royal Hospital for Women
Country [1] 839 0
Australia
Primary sponsor type
Hospital
Name
Department of EndoGynaecology Royal Hospital for Women
Address
Country
Australia
Secondary sponsor category [1] 706 0
None
Name [1] 706 0
not applicable
Address [1] 706 0
Country [1] 706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2107 0
South Eastern Area and Illawarra Health Service, Eastern Division
Ethics committee address [1] 2107 0
Ethics committee country [1] 2107 0
Australia
Date submitted for ethics approval [1] 2107 0
Approval date [1] 2107 0
Ethics approval number [1] 2107 0

Summary
Brief summary
This study will treat women with either one of two medications or placebo for three months prior to their surgery to observe the effect on their post-operative outcome with regard to symptomatology, change in quality of life and the ease of completing the procedure and time taken for the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35487 0
Address 35487 0
Country 35487 0
Phone 35487 0
Fax 35487 0
Email 35487 0
Contact person for public queries
Name 9794 0
Dr Jason Abbott
Address 9794 0
Department of Endogynaecology
Royal Hospital for Women
Level 2
Barker St
Randwick NSW 2031
Country 9794 0
Australia
Phone 9794 0
+61 2 93826557
Fax 9794 0
+61 2 93826244
Email 9794 0
[email protected]
Contact person for scientific queries
Name 722 0
Dr Jason Abbott
Address 722 0
Royal Hospital for Women
Level 2
Barker St
Randwick NSW 2031
Country 722 0
Australia
Phone 722 0
+61 2 93826557
Fax 722 0
+61 2 93826244
Email 722 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.