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Trial registered on ANZCTR
Registration number
ACTRN12624000927527
Ethics application status
Approved
Date submitted
10/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
ENDOmetriosis appearance with hormonal COntraceptives at LaparOscopy: a pRospective cohort study (ENDO-COLOR Trial)
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Scientific title
ENDOmetriosis appearance with hormonal COntraceptives at LaparOscopy: a pRospective cohort study (ENDO-COLOR Trial) in 18-60 year old women
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Secondary ID [1]
312489
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ENDO-COLOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
334347
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Condition category
Condition code
Reproductive Health and Childbirth
330995
330995
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
All participants planned for laparoscopic excision of endometriosis who meet inclusion and exclusion criteria will be divided into two groups; hormonal users (HUs) and non-users (NUs).
Hormone use will be defined as women using any of the following within 30 days of surgery; combined hormonal contraceptive pill, progesterone only contraceptive pill, contraceptive implant (Implanon NXT), levonorgestrel releasing intrauterine device (LNG-IUD) or a progesterone depot contraceptive injection within 90 days of surgery. A preoperative participant questionnaire will capture participant reported hormone use. All other women will be defined as non-users.
Participants will be recruited pre-operatively and followed up for 6 months following laparoscopic excision of endometriosis until completion of the 6 month postoperative questionnaire.
Demands on participants
Participants of this study will be asked to consent to enrolment, complete a preoperative and postoperative questionnaire, and to have intraoperative medical data prospectively collected by research staff.
The participant questionnaires include questions about:
- Hormonal medication use
- Demographics
- Pelvic pain
- Past medical history
- EHP-30 to assess quality of life
These will be assessed with an online questionnaire administered through RedCap. We estimate this to take participants 20-30 minutes to complete.
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Intervention code [1]
329006
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Diagnosis / Prognosis
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Comparator / control treatment
All women not meeting the aforementioned criteria as hormonal contraceptive users will be defined as non-users.
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Control group
Active
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Outcomes
Primary outcome [1]
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Colour of endometriosis lesions at laparoscopy, presented as the frequency and percentage of participants with black lesions.
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Assessment method [1]
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Colour of endometriosis lesions will be assessed by both the surgeon intraoperatively and on review of intraoperative images by a research assistant, not involved in patient care. Where disagreement exists on lesion colour, a third clinician will review the intraoperative images. The surgeon will be involved in preoperative and postoperative care and may be aware of the patient’s hormone use. The research clinician will be blinded to the patient’s hormonal contraceptive use. Individual lesions will be classified as white, black or red. Overall, participants' lesions will be classified as the predominant colour present or mixed, where lesions of two colours make up more than 30% of all lesions.
Lesion colour will be defined in keeping with the American Society of Reproductive Medicine revised (r-ASRM) classification of endometriosis. This describes implant types as 1) red if they appear red, red-pink, flamelike, vesicular blobs or clear vesicles, 2) white if they appear as opacifications, peritoneal defects or yellow-brown and 3) black if they appear as black, haemosiderin deposits or blue.
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Timepoint [1]
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At laparoscopy
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Secondary outcome [1]
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Percentage and frequency of stage of endometriosis by r-ASRM stage.
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Assessment method [1]
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Endometriosis stage will be reported with a classification toolbox as per recommendations from the World Endometriosis Society consensus statement. The key part of this toolbox is the r-ASRM staging system, which stages endometriosis from stages 1 to 4. The other component is the Enzian Classification for Deep Infiltrating Endometriosis (DIE), which will be used if DIE is present. This will be recorded by the operating surgeon or assistant at the time of operation. Laparoscopies will be performed by consultant gynaecologists who hold Australasian Gynaecological Endoscopy and Surgery Society (AGES) membership or by a gynaecology registrar completing advanced training in minimally invasive laparoscopy.
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Timepoint [1]
437364
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At laparoscopy
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Secondary outcome [2]
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Colour of endometriosis lesions, presented as frequency and percentage of participants with each of the four lesion colours in the hormonal medication user (HU) and non-hormone user (NU) groups.
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Assessment method [2]
437365
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Colour of endometriosis lesions will be assessed by both the surgeon intraoperatively and on review of intraoperative images by a research assistant, not involved in patient care. Where disagreement exists on lesion colour, a third clinician will review the intraoperative images. The surgeon will be involved in preoperative and postoperative care and may be aware of the patient’s hormone use. The research clinician will be blinded to the patient’s hormonal contraceptive use. Individual lesions will be classified as white, black or red. Overall, participants' lesions will be classified as the predominant colour present or mixed, where lesions of two colours make up more than 30% of all lesions.
Lesion colour will be defined in keeping with the American Society of Reproductive Medicine revised (r-ASRM) classification of endometriosis. This describes implant types as 1) red if they appear red, red-pink, flamelike, vesicular blobs or clear vesicles, 2) white if they appear as opacifications, peritoneal defects or yellow-brown and 3) black if they appear as black, haemosiderin deposits or blue.
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Timepoint [2]
437365
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At laparoscopy
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Secondary outcome [3]
437366
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Histopathological diagnosis of endometriosis presented as percentage and frequency.
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Assessment method [3]
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All excised lesions will be sent in formalin solution for histological assessment by a pathologist. Histopathological diagnosis will be defined by two or more of endometrial glands, endometrial stroma and hemosiderin-laden macrophages. Pathologists will be unaware of the patient’s hormonal contraceptive use and be informed only of the suspected diagnosis of endometriosis and biopsy specimen location.
Histopathology findings will be recorded by a research assistant through a pre-specified questionnaire.
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Timepoint [3]
437366
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Histopathology review questionnaire, completed 1-2 weeks postoperatively.
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Secondary outcome [4]
437367
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Percentage and frequency of stage of endometriosis by deep infiltrating endometriosis (DIE) stage.
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Assessment method [4]
437367
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Endometriosis stage will be reported with a classification toolbox as per recommendations from the World Endometriosis Society consensus statement. Within this toolkbox we will use the Enzian Classification for Deep Infiltrating Endometriosis (DIE), which will be used if DIE is present. This will be recorded by the operating surgeon or assistant at the time of operation. Laparoscopies will be performed by consultant gynaecologists who hold Australasian Gynaecological Endoscopy and Surgery Society (AGES) membership or by a gynaecology registrar completing advanced training in minimally invasive laparoscopy.
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Timepoint [4]
437367
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At laparoscopy
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Secondary outcome [5]
437368
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Mean difference in pain scores on passing urine.
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Assessment method [5]
437368
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Pain score assessed by 11-point Likert scale from 0-10.
Respondents will be asked “Over the past 4 weeks how would you rate your pain with each activity? (0 being no pain, 10 being the worst pain possible)” and then to rate their pain on average and at its worst.
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Timepoint [5]
437368
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Preoperative questionnaire, 6 weeks questionnaire
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Secondary outcome [6]
437369
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Mean difference in pelvic pain scores.
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Assessment method [6]
437369
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Pain score assessed by 11-point Likert scale from 0-10.
Respondents will be asked “Over the past 4 weeks how would you rate your pain with each activity? (0 being no pain, 10 being the worst pain possible)” and then to rate their current pain, unrelated to periods, on average and at its worst.
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Timepoint [6]
437369
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Preoperative questionnaire, 6 week postoperative questionnaire
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Secondary outcome [7]
437370
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Mean difference in EHP-30 score.
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Assessment method [7]
437370
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Health related quality of life will be assessed through the participant questionnaires by the Endometriosis Health Profile Questionnaire-30 (EHP-30). The EHP-30 is the most commonly used and best validated, endometriosis specific, quality of life scale.
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Timepoint [7]
437370
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Preoperative participant questionnaire, 6 week postoperative participant questionnaire.
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Secondary outcome [8]
437371
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Percentage and frequency of haemosiderin-laden macrophages on histopathology reports.
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Assessment method [8]
437371
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All excised lesions will be sent in formalin solution for histological assessment by a pathologist. Histopathological diagnosis will be defined by two or more of endometrial glands, endometrial stroma and hemosiderin-laden macrophages. Pathologists will be unaware of the patient’s hormonal contraceptive use and be informed only of the suspected diagnosis of endometriosis and biopsy specimen location.
Histopathology findings will be recorded by a research assistant through a pre-specified questionnaire.
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Timepoint [8]
437371
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Histopathology review questionnaire, completed 1-2 weeks postoperatively.
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Secondary outcome [9]
437685
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Mean difference in pain scores on opening bowels
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Assessment method [9]
437685
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Pain score assessed by 11-point Likert scale from 0-10.
Respondents will be asked “Over the past 4 weeks how would you rate your pain with each activity? (0 being no pain, 10 being the worst pain possible)” and then to rate their pain on average and at its worst.
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Timepoint [9]
437685
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Preoperative questionnaire, 6 weeks questionnaire
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Secondary outcome [10]
437687
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Mean difference in pain scores with sexual intercourse
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Assessment method [10]
437687
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Pain score assessed by 11-point Likert scale from 0-10.
Respondents will be asked “Over the past 4 weeks how would you rate your pain with each activity? (0 being no pain, 10 being the worst pain possible)” and then to rate their pain on average and at its worst.
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Timepoint [10]
437687
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Preoperative questionnaire, 6 weeks questionnaire
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Secondary outcome [11]
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Mean difference in period pain scores.
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Assessment method [11]
437688
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Pain score assessed by 11-point Likert scale from 0-10.
Respondents will be asked “Over the past 4 weeks how would you rate your pain with each activity? (0 being no pain, 10 being the worst pain possible)” and then to rate their pain on average and at its worst that is associated with cyclical vaginal bleeding.
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Timepoint [11]
437688
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Preoperative questionnaire, 6 weeks questionnaire
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Eligibility
Key inclusion criteria
Women aged between 18-60 years of age undergoing laparoscopy for diagnosis and excision of suspected endometriosis.
Women with the capacity to give written consent freely
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Previous surgical excision of endometriosis
- Use of GNRH analogues, danazol, selective oestrogen receptor modulators in the 6 months prior to laparoscopy
- Patients unsure of their current or recent hormonal contraceptive use
- Pregnant women
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Primary outcome
The primary outcome, colour of endometriosis lesions, will be presented in a contingency table as frequency and percentage of black lesions in the HCU compared to the NU group. As we expect the event rate of black lesions to be greater than 10%, relative risk will be used to present the estimate of effect. Their association will be analysed with a Chi-squared test to test for statistical significance, charting frequencies in a 2 x 2 contingency table.
Secondary outcomes
Lesion colour will also be compared between the HCU and NU groups in a contingency table with lesion colour (white, black, red or mixed) as the dependent variable.
Categorical data will be presented as frequencies and percentages. Correlations will be analysed using a chi-squared test or Fischer’s exact test for variables with expected frequencies of less than 5 in a single cell of a resultant contingency table.
Mean difference in pelvic pain, pain in other domains and EHP-30 scores will be assessed with a dependent-samples t-test or Wilcoxon’s signed-rank test (depending on normality of data) by comparing preoperative scores with 6 week postoperative scores between the HCU and NU groups.
Estimates of effect will be presented as relative risk for categorical variables or mean difference for continuous variables, with accompanying 95% confidence intervals. A p value of < 0.05 will be considered as statistically significant.
Given the relatively small sample size we will not undertake regression analyses.
Every attempt will be made to collect full follow-up data on all women (unless a woman withdraws consent for follow-up data collection). It is thus anticipated that missing data will be minimal. Women with missing primary outcome data will not be included in the primary analysis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
25/04/2022
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Date of last participant enrolment
Anticipated
31/07/2024
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Actual
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Date of last data collection
Anticipated
11/09/2024
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Actual
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Sample size
Target
106
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Accrual to date
92
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
316909
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Government body
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Name [1]
316909
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South Eastern Sydney Local Health District
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Address [1]
316909
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Country [1]
316909
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Australia
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Funding source category [2]
316990
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Other Collaborative groups
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Name [2]
316990
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Sydney Minimally Invasive Gynaecological Research Group (SMIGs-RG)
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Address [2]
316990
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Country [2]
316990
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Sydney Minimally Invasive Gynaecology Research Group
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Address
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Country
Australia
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Secondary sponsor category [1]
319158
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None
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Name [1]
319158
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Address [1]
319158
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Country [1]
319158
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315667
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South Eastern Sydney Local Health District HREC
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Ethics committee address [1]
315667
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https://www.seslhd.health.nsw.gov.au/services-clinics/directory/research-home/ethics
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Ethics committee country [1]
315667
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Australia
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Date submitted for ethics approval [1]
315667
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10/02/2021
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Approval date [1]
315667
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30/03/2021
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Ethics approval number [1]
315667
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2021/ETH00246
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Summary
Brief summary
Endometriosis is a common condition where deposits of endometrium are found outside of the uterus, typically in other pelvic organs. Endometriosis has a significant impact on quality of life, pain, sexual function and fertility for women who suffer from it. Laparoscopy (keyhole surgery) plays a crucial role in allowing diagnosis of endometriosis and therapeutic benefit in excision of disease. While black pigmented “powder-burn” endometriosis lesions are classically described, other non-pigmented red or white lesions are common. Causes of variation in lesion appearance have not been well explored and are not well understood. Past studies have found high concentrations of iron deposition in endometriotic lesions compared to normal peritoneum. This iron deposition is due to cyclical bleeding into ectopic endometrial implants, due to falling progesterone levels at the end of the menstrual cycle. Macrophages (a type of white blood cell) initially phagocytose (ingest) haemoglobin, which is broken down into iron and then converted to hemosiderin, which is typically black or pigmented. These hemosiderin-laden macrophages are one of the diagnostic features of endometriosis on histopathology. Hormonal contraceptive medications are commonly used to treat endometriosis. They prevent pain through a range of mechanisms but crucially by suppressing a woman's production of sex hormones, thereby preventing cyclical bleeding from endometriosis deposits and an associated inflammatory response. We hypothesize that the use of hormonal contraceptives would inhibit proliferation of endometrial tissue and subsequent bleeding from endometriotic deposits. This effect of hormonal contraceptives would also reduce the number of haemosiderin-laden macrophages in endometriosis lesions, thereby reducing their black appearance. No previous studies have investigated the factors that influence lesion appearance at laparoscopy. As such reasons for variation in lesions and the effect of hormonal contraceptives on lesion appearance is unknown. Fewer black lesions may lead to more missed lesions at laparoscopy, with more lesions appearing red or white. It may also lead to atrophy of endometrial glandular tissue leading to difficulty in diagnosing endometriosis on histopathology. If this effect exists, awareness of it by surgeons would be useful and may facilitate complete excision of endometriosis at initial laparoscopy. This has been shown to improve pain and quality of life compared to incomplete excision. Our primary objective is to assess whether the use of hormonal contraceptives effects the colour of endometriosis lesions at laparoscopy. Our secondary objective is to assess if hormonal contraceptives effect the histological appearance of endometriosis lesions and if this this is related to their colour.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr William Stobie
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Address
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Northern Beaches Hospital, 105 Frenchs Forest Rd W, Frenchs Forest NSW 2086
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Country
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Australia
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Phone
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+61 425891556
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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William Stobie
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Address
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Northern Beaches Hospital, 105 Frenchs Forest Rd W, Frenchs Forest NSW 2086
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Country
135439
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Australia
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Phone
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+61 425891556
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Fax
135439
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Email
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[email protected]
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Contact person for scientific queries
Name
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William Stobie
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Address
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Northern Beaches Hospital, 105 Frenchs Forest Rd W, Frenchs Forest NSW 2086
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Country
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Australia
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Phone
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+61 425891556
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Fax
135440
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We plan to publish data and findings in full in a relevant peer-reviewed medical journal on completion of the trial. At present there is no plan, nor do we have a platform to publish individual participant data, but this may be shared for the purposes of future systematic reviews on request.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23976
Ethical approval
388095-(Uploaded-10-07-2024-05-52-45)-383564-(Uploaded-02-04-2022-14-57-40)-Study-related document.pdf
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.
Download to PDF