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Trial registered on ANZCTR


Registration number
ACTRN12618001410246
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
23/08/2018
Date last updated
30/07/2021
Date data sharing statement initially provided
26/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the first laparoscopy in an adolescent and young adult female population and its association with chronic pelvic pain
Scientific title
Effect of the first laparoscopy in an adolescent and young adult female population and its association with chronic pelvic pain
Secondary ID [1] 295843 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pelvic Pain 309294 0
Condition category
Condition code
Reproductive Health and Childbirth 308167 308167 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised controlled pilot study looking at women aged 16-25 with chronic pelvic pain who will be seen at the Royal Hospital for Women. These women will be divided into two groups - surgical and non-surgical. Those in the surgical group will undergo a laparoscopy and those in the non-surgical group will have their pain management managed through medications. A laparoscopy is a key-hole surgery using a camera, or laparoscope, to view the internal organs. In individuals with chronic pelvic pain, the main purpose of a laparoscopy is to identify and remove any endometriosis. The duration of this procedure is dependent on the extent of endometriosis found, but is usually around 45 minutes. Both groups will have their progress tracked over 2 years to see how well they respond to treatment, how many surgeries they go on to have and what the outcomes of these surgeries are.
Intervention code [1] 312180 0
Treatment: Surgery
Comparator / control treatment
The control group will have their chronic pelvic pain managed through non-surgical means (e.g. medications). All medications that will be used are TGA approved and currently part of standard care in the management of chronic pelvic pain.
Control group
Active

Outcomes
Primary outcome [1] 307135 0
Location and severity of Pelvic pain using the validated questionnaire, the Modified Brief Pain Inventory
Timepoint [1] 307135 0
6 weeks, 6 months, 12 months (primary timepoint) and 24 months following initial presentation
Primary outcome [2] 307152 0
Quality of life using the validated questionnaire, EURO-QOL 5D
Timepoint [2] 307152 0
6 weeks, 6 months, 12 months (primary timepoint) and 24 months following initial presentation
Primary outcome [3] 307153 0
Sexual function using the validated questionnaire, Female Sexual Function Index
Timepoint [3] 307153 0
6 weeks, 6 months, 12 months (primary timepoint) and 24 months following initial presentation
Secondary outcome [1] 350803 0
Number and type of medications used
Timepoint [1] 350803 0
6 weeks, 6 months, 12 months and 24 months following initial presentation using the study-specific questionnaire conducted in person or over the phone
Secondary outcome [2] 350804 0
Number of surgeries and and surgical findings (e.g. r-AFS staging of endometriosis is present)
Timepoint [2] 350804 0
6 weeks, 6 months, 12 months and 24 months following initial presentation using the study-specific questionnaire conducted in person or over the phone
Secondary outcome [3] 350805 0
Number of presentations to the Emergency department
Timepoint [3] 350805 0
6 weeks, 6 months, 12 months and 24 months following initial presentation using the study-specific questionnaire conducted in person or over the phone

Eligibility
Key inclusion criteria
- Any women from the ages of 16 to 25 years old presenting to gynaecological clinic with pelvic pain lasting for more than 6 months in duration at the Royal Hospital for Women with no cause found on routine investigations (pelvic ultrasound and blood tests)
- Participants who are willing to participate for the duration of study and all follow ups
- Participants will be considered for enrolment based on clinical findings and subject to gaining informed consent from the participant
Minimum age
16 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not willing to follow up for the next 2 years
- Non-English speaking
- Any pelvic or gynaecological malignancy
- Current pregnancy

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation of subjects in blocks of 5
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There was no similar data with which to perform a power calculation. The primary endpoint is pain and a reduction in this measure. Therefore the Visual analogue scale (VAS) was considered the best choice for estimating a reduction in pain. Several attempts have been made to identify the amount of change necessary to be clinically significant. For chronic back pain, a change of about 20% in the VAS is regarded to be clinically significant (Haefeli & Elfering 2006). In order to calculate a clinically meaningful change in the VAS scale between the two groups, a difference of at least 40% in VAS was used to calculate the sample size to achieve 80% power to detect a difference between the surgery and non surgery groups at 6 months post surgery while using a two sided t-test at 0.05 significant level. Therefore 44 subjects are required in each arm (22 in the surgery group, and 22 in the non surgery group) to achieve this.

Student t-test will be used when comparing continuous variables (e.g. pain scores) between groups, and paired t test where comparing the woman as her own control. The Mann-Whitney test will be performed for non parametric data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11688 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 23755 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 300440 0
Charities/Societies/Foundations
Name [1] 300440 0
Australasian Gynaecological and Endoscopy Surgery Society
Country [1] 300440 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Gynaecological and Endoscopy Surgery Society
Address
YRD Event Management
PO Box 717 Indooroopilly
QLD 4068 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 299903 0
None
Name [1] 299903 0
Address [1] 299903 0
Country [1] 299903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301240 0
South East Sydney Local Heath District Human Research Ethics Committee
Ethics committee address [1] 301240 0
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, RANDWICK NSW 2031
Ethics committee country [1] 301240 0
Australia
Date submitted for ethics approval [1] 301240 0
01/12/2017
Approval date [1] 301240 0
06/04/2018
Ethics approval number [1] 301240 0
HREC 17/348

Summary
Brief summary
This is a randomised controlled pilot study to examine the effect of key-hole surgery on pelvic pain in women aged 16-25 years old who present with pain with no obvious cause to the gynaecology service at the Royal Hospital for Women. Women will be randomised into either non-surgical (oral medications) or surgical (laparoscopic) management. Laparoscopy is generally performed to investigate and treat endometriosis although it is common for there to be no findings on laparoscopy, and if endometriosis is found, pain can persist despite surgery. Therefore the optimum management for pelvic pain in adolescent and young women is unknown. The objective of this study is to demonstrate the effect of laparoscopy on pre operative; immediate and long-term post-operative pelvic pain and quality of life using standardised questionnaires. Patients will be followed-up at 6 weeks, 6 months, 12 months and 24 months after initiation of treatment.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2980 2980 0 0
/AnzctrAttachments/375822-2018.04.06 Ethics Approval 17-348 (1).pdf (Ethics approval)
Attachments [2] 2981 2981 0 0
/AnzctrAttachments/375822-Information and Consent Form .docx (Participant information/consent)

Contacts
Principal investigator
Name 86346 0
Dr Rebecca Deans
Address 86346 0
The Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 86346 0
Australia
Phone 86346 0
+61 2 9382 6111
Fax 86346 0
Email 86346 0
[email protected]
Contact person for public queries
Name 86347 0
Rebecca Deans
Address 86347 0
The Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 86347 0
Australia
Phone 86347 0
+61 2 9382 6111
Fax 86347 0
Email 86347 0
[email protected]
Contact person for scientific queries
Name 86348 0
Rebecca Deans
Address 86348 0
The Royal Hospital for Women
Barker St, Randwick NSW 2031
Country 86348 0
Australia
Phone 86348 0
+61 2 9382 6111
Fax 86348 0
Email 86348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.