ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

nil

Trial acronym

nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endometriosis / pelvic pain

Condition category

Condition code

Surgery

Surgical techniques

Reproductive Health and Childbirth

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]

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]

Pain assessment using visual analogue scales and validated questionnaires

Timepoint [1]

12 months after surgery

Primary outcome [2]

Quality of life assessed by quality of life validated questionnaires

Timepoint [2]

12 months from surgery

Secondary outcome [1]

analgesia requirement by assessing total amount of medication required in the post operative period in hospital using the patient's medication charts

Timepoint [1]

1 week following surgery

Secondary outcome [2]

Hospital stay by assessing hours of admission to the hospital and ward based on hospital records

Timepoint [2]

1 week follwing surgery

Secondary outcome [3]

Fertility assessed by questionnaire and medical records of consultation

Timepoint [3]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Jason Abbott

Address [1]

c/o Royal Hospital for Women, Barker St Randwick, NSW 2031

Country [1]

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]

Individual

Name [1]

Mr Ray Garry

Address [1]

South Cleveland Hospital,
Marton Road, Middlesbrough,
Cleveland TS4 3BW
United Kingdom

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Tees Local Research Ethics Committee

Ethics committee address [1]

South Tees Hospitals NHS Trust Ethics Committee
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

Approval date [1]

02/12/1998

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

A/Prof Jason Abbott

Address

Royal Hospital for Women and University of New South Wales, Barker St, Randwick, NSW 2031

Country

Australia

Phone

+61293826111

Fax

+61293826444

j.abbott@unsw.edu.au

Contact person for scientific queries

Name

A/Prof Jason Abbott

Address

Royal Hospital for Women and University of New South Wales, Barker St, Randwick, NSW 2031

Country

Australia

Phone

+61293826111

Fax

+61293826444

j.abbott@unsw.edu.au

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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