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Trial registered on ANZCTR


Registration number
ACTRN12611000251921
Ethics application status
Approved
Date submitted
27/06/2010
Date registered
8/03/2011
Date last updated
8/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double blinded randomised controlled study on the effect of laparoscopic excision on endometriosis
Scientific title
A double blinded randomised controlled trial on the effects of laparoscopic excision compared to placebo on pain and quality of life in women with endometriosis
Secondary ID [1] 259713 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis / pelvic pain 257659 0
Condition category
Condition code
Surgery 257839 257839 0 0
Surgical techniques
Reproductive Health and Childbirth 257840 257840 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic surgery which involves puncture of the abdomen at 4 sites, inflation of the abdomen with carbon dioxode, a review of the structures and disease and excision of the disease in the surgical arm. In the placebo surgery arm control group, scoring of disease and infusion saline fluid is used post-surgery in the placebo surgery arm. The surgery is then repeated again 6 months after the 1st surgery (crossover) with scoring and excision of disease in both groups. Therefore there is a 6 month washout period. Patients are then followed up for 1 year with interview and questionnaire.
Intervention code [1] 256730 0
Treatment: Surgery
Comparator / control treatment
The control group will have surgery - 4 puncture laparoscopy with visualisation and scoring of endometriosis at the index surgery. Infusion with normal saline a drain placed in the abdomen and sent to recover as per the surgery arm. Six months later all patients undergo a second surgery, and any disease is scored and excised in the control group, as per the active surgery group.
Control group
Active

Outcomes
Primary outcome [1] 258698 0
Pain assessment using visual analogue scales and validated questionnaires
Timepoint [1] 258698 0
12 months after surgery
Primary outcome [2] 258699 0
Quality of life assessed by quality of life validated questionnaires
Timepoint [2] 258699 0
12 months from surgery
Secondary outcome [1] 264724 0
analgesia requirement by assessing total amount of medication required in the post operative period in hospital using the patient's medication charts
Timepoint [1] 264724 0
1 week following surgery
Secondary outcome [2] 264725 0
Hospital stay by assessing hours of admission to the hospital and ward based on hospital records
Timepoint [2] 264725 0
1 week follwing surgery
Secondary outcome [3] 264726 0
Fertility assessed by questionnaire and medical records of consultation
Timepoint [3] 264726 0
12 months following surgery

Eligibility
Key inclusion criteria
Pelvic pain (of greater than six months duration) with suspected endometriosis
Examination findings suggestive of endometriosis
A Ultrasound findings suggestive of an endometrioma.
B Rectal ultrasound findings suggestive of infiltrative endometriosis such as uterosacral or rectal wall involvement.
C Previous diagnostic or operative laparoscopy with visual suggestion of, or biopsy proven, disease.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Suspected diagnosis of gynaecological malignancy or its precursors.
2. Current or chronic relapsing pelvic inflammatory disease.
3. Current pregnancy.
4. Infertility and endometriosis without pelvic pain.
5. Unable to give informed consent.
6. Unable or unwilling to attend for both surgeries and for follow-up to twelve months.
7. No histological confirmation of endometriosis.

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)
Women who met the inclusion criteria were assessed in the outpatient department of a large district general hospital. Either the consultant or research fellow conducting the clinic discussed the various options for treatment with patients. If the patient requested surgical intervention, then they were informed of the research study. Further information regarding the study was given to them by the primary researcher and included the following:
1) The format of the study, which required two surgical procedures.
2) The fact that one of their surgical procedures would be a diagnostic procedure and may not provide them with any direct medical benefit.
3) That participation in the trial was voluntary and their medical care would not be affected in any way if they did not participate.
4) That their treating doctor would be unable to give any information to them, their family, or their general practitioner until the completion of the trial period.
5) That they would not be able to see their treating doctor or ask any questions about the procedure until after the completion of the trial period.
6) That a doctor whom they had not met and was not participating in their surgical management would care for them in the post-operative setting.
7) That they would have the same drain, catheter, intravenous fluid lines and analgesia machines at each surgical intervention.
8) That they would be able to request removal of their lines and discharge themselves, pending medical suitability.
9) That they would be given written information regarding the study (see appendix B) and could discuss their participation with their partner, family or medical practitioner.
10) That they could discuss any aspect of the study with their general practitioner or other medical professional not involved with the study.
11) That at the end of the study period, they would meet the principal researcher (JA) after completing a final questionnaire and would have a full physical examination. At this time, any questions relating to the study would be addressed and the order of procedures explained to the participant.
12) A letter to the general practitioner would be sent at the conclusion of the study outlining the order of procedures, with a copy of the operation reports sent at this time.
Having met the entry criteria, women who consented to participate in the study were asked to complete an initial questionnaire providing demographic data, parity, gynaecologic and menstrual history, medical and surgical history, analgesia usage, previous treatments for suspected or confirmed endometriosis, and infertility treatments. Allocation upon randomisation was concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was by computer generated randomisation blocks, with the entry number concealed in an opaque envelope. The number was then entered into a computer database, with the randomisation group being exposed after patient details were entered. Patients were listed for surgery as soon as possible after allocation. Patients were advised that they could withdraw from the study at any time without their medical care being affected.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 2727 0
United Kingdom
State/province [1] 2727 0

Funding & Sponsors
Funding source category [1] 257216 0
Self funded/Unfunded
Name [1] 257216 0
Dr Jason Abbott
Country [1] 257216 0
Australia
Primary sponsor type
Individual
Name
Dr Jason Abbott
Address
c/o Royal Hospital for Women, Barker St Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 256466 0
Individual
Name [1] 256466 0
Mr Ray Garry
Address [1] 256466 0
South Cleveland Hospital,
Marton Road, Middlesbrough,
Cleveland TS4 3BW
United Kingdom
Country [1] 256466 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259239 0
South Tees Local Research Ethics Committee
Ethics committee address [1] 259239 0
South Tees Hospitals NHS Trust Ethics Committee
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
Ethics committee country [1] 259239 0
United Kingdom
Date submitted for ethics approval [1] 259239 0
Approval date [1] 259239 0
02/12/1998
Ethics approval number [1] 259239 0
98/59

Summary
Brief summary
Aim: To assess the role of laparoscopic excision of endometriosis in women who have confirmed disease, and assess pain and quality of life (QoL) outcomes at 6 and 12 months following surgery.

Methods: A double blind randomised, placebo-controlled, cross-over study. Women were randomised to an immediate or a delayed group. In the immediate group, women received laparoscopic excision of endometriosis at the time of first surgery and then a second look laparoscopy, with or without excision of additional disease 6 months later. In the delayed surgery group, women received a staging laparoscopy without excision at the time of first surgery, followed by laparoscopic excision of endometriosis 6 months later. Pain was assessed by dichotomous and continuous variables and QoL was assessed using the EuroQOL, SF-12 and sexual activity questionnaires.

Patients: 52 women with suspected endometriosis were randomised in the study.

Results: Three women withdrew before surgery owing to pregnancy; three without reason and seven were excluded following surgery when endometriosis was not confirmed. The remaining 39 women were operated on and the results analyses by intention to treat. At 6 months following surgery 1, 6/19 women (32%) in the delayed surgery group reported an improvement in symptoms, and 13/19 (68%) reported no improvement in symptoms. In the immediate surgery group, 16/20 (80%) reported an improvement in symptoms, and 4/20 (20%) reported no improvement in symptoms. There was a significant difference between the two groups (p=0.002). There was a significant improvement in many aspects of quality of life for women in the immediate surgery group compared to baseline, but no significant improvement for women in the delayed surgery group. Three women in the immediate surgery group became pregnant following their first surgery and did not have surgery 2. At 6 months following surgery 2, 15/18 women (83%) in the delayed surgery group reported an improvement in symptoms, and 3/18 (17%) reported no improvement in symptoms. The other woman in this group required treatment at surgery 1 due to severe disease. In the immediate surgery group, 8/15 (53%) of women reported a change in symptoms at 6 months following surgery 2, and 7/15 women (47%) reported no improvement in symptoms. There were 3 women pregnant in this group, one withdrawal following surgery, but before final follow-up and one women who had a complication at surgery 1 and did not have second surgery. There were significant improvements in all aspects of quality of life in both groups at the end of the study compared to baseline.

Conclusion: Laparoscopic excision of endometriosis for women appears to be effective in reducing pain symptoms and improving quality of life compared to placebo. Surgery is associated with a 30% placebo response rate that is not dependent on severity of disease. Approximately 20% of women do not report an improvement following surgery for endometriosis. There is a significant improvement in many aspects of quality of life following surgery for endometriosis compared to placebo.
Trial website
nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31344 0
Address 31344 0
Country 31344 0
Phone 31344 0
Fax 31344 0
Email 31344 0
Contact person for public queries
Name 14591 0
A/Prof Jason Abbott
Address 14591 0
Royal Hospital for Women and University of New South Wales, Barker St, Randwick, NSW 2031
Country 14591 0
Australia
Phone 14591 0
+61293826111
Fax 14591 0
+61293826444
Email 14591 0
[email protected]
Contact person for scientific queries
Name 5519 0
A/Prof Jason Abbott
Address 5519 0
Royal Hospital for Women and University of New South Wales, Barker St, Randwick, NSW 2031
Country 5519 0
Australia
Phone 5519 0
+61293826111
Fax 5519 0
+61293826444
Email 5519 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

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