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Trial registered on ANZCTR
Registration number
ACTRN12613001049763
Ethics application status
Approved
Date submitted
11/09/2013
Date registered
20/09/2013
Date last updated
20/09/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
To excise or ablate endometriosis? A prospective randomized double blinded trial with 5 years follow-up.
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Scientific title
Prospective randomized double blinded controlled trial comparing treatment of endometriosis with excision versus ablation on pain, rates of pregnancy, repeat surgery and use of hormonal medication in the 5 years post-operation.
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Secondary ID [1]
283188
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
290049
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Condition category
Condition code
Surgery
290425
290425
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0
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Surgical techniques
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Reproductive Health and Childbirth
290494
290494
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Interventions - Excision of endometriosis. To excise the endometriosis, spade with monopolar current or scissors are used to cut out the endometriosis. Duration of the procedure depends on the amount of endometriosis present and expertise of the surgeon.
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Intervention code [1]
287914
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Treatment: Surgery
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Comparator / control treatment
Comparator - ablation of endometriosis. Monopolar or bipolar diathermy is used to ablate and burn the endometriosis. Duration of the ablation on the endometriosis is determined by the surgeon. The duration of the total procedure depends on the amount of endometriosis present.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in pain VAS scores during 5 years post-operation
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Assessment method [1]
290451
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Timepoint [1]
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5 years post operation
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Secondary outcome [1]
304543
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Rates of pregnancy.
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Assessment method [1]
304543
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Timepoint [1]
304543
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5 years post-operation. Assessed via post operative questionnaires.
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Secondary outcome [2]
304700
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Repeat Surgery
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Assessment method [2]
304700
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Timepoint [2]
304700
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5 years post operation. Assessed via post operative questionnaires.
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Secondary outcome [3]
304701
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Hormonal medication
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Assessment method [3]
304701
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Timepoint [3]
304701
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5 years post operation. Assessed via post operative questionnaires.
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Eligibility
Key inclusion criteria
Women booked to have a laparoscopy to manage pain symptoms suggestive of endometriosis, over 18 years, speak English, not be using or planning to use continuous hormonal medications and give consent to the trial.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Under 18 years and over 50 years.
Do not speak English.
Do not consent.
Use or planning to use continuous hormonal medications.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled in pre-admission clinic.
During laparoscopy, if endometriosis is visually diagnosed and it does not involve bowel, bladder or ureter muscularis, then treatment is randomised to excision or ablation using computer generated randomisation in numbered, sealed, opaque envelops.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence placed in numbered opaque sealed envelops.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The power calculation assumed a base reduction in overall pain VAS score of 3.7 (estimated from the reduction in mean VAS pain score at 6 months in Sutton’s study in 1994 [Sutton et al. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis. Fertil Steril 1994;62:696–700]); a clinically significant difference between groups being a change of VAS score of 1.0; an SD of 2.0; and a power of 80% and alpha value of 5%. The calculated sample size was N = 49 in each group. To allow for wastage a sample size of 120 (60 in each group) was initially chosen. However, an interim analysis demonstrated a subject loss of 35% at 1 year, the sample size was then increased to 180 to compensate.
Proportions were compared with Chi-squared testing. Continuous variables were compared using the t-test for independent variables and Welch’s t-test if the assumption of equal variance was not met. Medians were used to describe rAFS scores and comparison was with the Mann-Whitney U test. Where potential confounding factors were present (defined when p<0.25) multivariate linear regression analysis was performed with backward removal of variables. Survivor analysis (log rank test statistic) was used for comparing dichotomous events over time such as pregnancy and further treatments (medical and surgical). Repeated measures of continuous variables were analyzed using one way analysis of variance (ANOVA) with Tamhane’s T2 post-hoc test where equal variance was not assumed. Differences were considered significant if p<0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2001
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Actual
2/07/2001
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Date of last participant enrolment
Anticipated
28/09/2007
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Actual
28/09/2007
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
7341
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
287933
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Charities/Societies/Foundations
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Name [1]
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Australian Gynaecological Endoscopy Society Research Foundation
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Address [1]
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282 Edinburgh Road
CASTLECRAG NSW 2068
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Country [1]
287933
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Australia
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Funding source category [2]
287934
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Charities/Societies/Foundations
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Name [2]
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L.E.W. Carty Charitable Fund
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Address [2]
287934
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27 Windsor Place
Melbourne
Victoria 3000
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Country [2]
287934
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Australia
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Funding source category [3]
287935
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Charities/Societies/Foundations
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Name [3]
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Royal Women's Hospital Foundation
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Address [3]
287935
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20 Flemington Road
Parkville VIC 3052
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Country [3]
287935
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Australia
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Primary sponsor type
Individual
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Name
A/Prof Martin Healey
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Address
Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
286657
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Individual
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Name [1]
286657
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Dr Claudia Cheng
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Address [1]
286657
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Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
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Country [1]
286657
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289862
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Research and Ethics Committees of the Royal Women’s Hospital
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Ethics committee address [1]
289862
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20 Flemington Road Parkville VIC 3052
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Ethics committee country [1]
289862
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Australia
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Date submitted for ethics approval [1]
289862
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19/05/1998
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Approval date [1]
289862
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14/10/1998
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Ethics approval number [1]
289862
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Project 98/12
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Summary
Brief summary
Objective: To compare reduction of pain following laparoscopy after ablation or excision of endometriosis. Design: A prospective, randomized, double-blind study. Setting: Endometriosis and pelvic pain clinic at a university teaching hospital. Patients: Women of reproductive age presenting with pelvic pain and visually proven endometriosis. Interventions: Subjects completed a questionnaire rating their various pains using visual analogue scales (VAS). Following visual identification subjects were randomised to treatment with ablation or excision by supervised training gynecologists as primary surgeon. Follow-up questionnaires documented pain levels every 3 months for 1 year then 6 monthly until 5 years. Main Outcome Measure: Change in pain VAS scores during 5 years post-operation and rates of pregnancy, repeat surgery and use of hormonal medication Results: There was a reduction in all pain scores over the five year follow up in both treatment groups. A significantly greater reduction in sex pain VAS scores was seen in the excision group at 3 years 6 months (p=0.015); 4 years 6 months (p=0.047) and at 5 years (p=0.031). More women went on to use medical treatments for endometriosis amongst the ablation group (p=0.004) by 5 years. Conclusions: Surgical treatment of endometriosis provides symptom reduction for up to 5 years. There are some limited areas, such as deep dyspareunia, where excision is more effective than ablation.
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Trial website
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Trial related presentations / publications
Part of the results was presented at the Australasian Gyneacological Endoscopy Society 23rd Annual Scientific Meeting, 7-9th March 2013.
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Martin Healey
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Address
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Royal Women's Hospital, Melbourne, Victoria, Australia and Department Obstetrics & Gyneacology, University of Melbourne, Victoria, Australia
20 Flemington Road. Parkville. Victoria. 3052
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Country
42818
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Australia
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Phone
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+61 3 9425 9833
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Fax
42818
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Email
42818
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[email protected]
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Contact person for public queries
Name
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Martin Healey
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Address
42819
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Royal Women's Hospital, Melbourne, Victoria, Australia and Department Obstetrics & Gyneacology, University of Melbourne, Victoria, Australia
20 Flemington Road. Parkville. Victoria. 3052
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Country
42819
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Australia
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Phone
42819
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+61 3 9425 9833
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Fax
42819
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Email
42819
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[email protected]
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Contact person for scientific queries
Name
42820
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Martin Healey
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Address
42820
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Royal Women's Hospital, Melbourne, Victoria, Australia and Department Obstetrics & Gyneacology, University of Melbourne, Victoria, Australia
20 Flemington Road. Parkville. Victoria. 3052
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Country
42820
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Australia
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Phone
42820
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+61 3 9425 9833
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Fax
42820
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Email
42820
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[email protected]
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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.
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