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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN63952470 |
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Date of registration:
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27/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing the impact of dienogest with short term gonadotropin-releasing hormone (GnRH) analogue usage in endometriosis prior to laparoscopic cystectomy.
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Scientific title:
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Comparing the impact of DIenogest with short term GnRH analogue usage in women with Endometriosis prior to laparoscopic Cystectomy: a randomised controlled trial |
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Date of first enrolment:
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01/06/2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN63952470 |
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Study type:
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Interventional |
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Study design:
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Interventional randomised controlled trial, single centre. (Treatment)
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Phase:
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Aizura Syafinaz
Ahmad Adlan |
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Address:
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104, SS22/2
Damansara Jaya
47400
Petaling Jaya
Malaysia |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with cyst suspicious of endometrioma
2. Cyst measures > 4 cm
3. Planned for a laparoscopic cystectomy
Exclusion criteria: Patients with cysts suspicious of malignancy.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis
Urological and Genital Diseases
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Intervention(s)
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Prior to the initiation of the study, blood will be taken for series of investigations- for AMH, Ca 125, FSH/LH level. Transvaginal ultrasound will be performed to look for antral follicular count.
Participants are allocated into one of three groups:
Group 1: No pretreatment administered pre-operatively (control group)
Group 2: single dose of GnRH analogue will be given (s/c lucrin 3.75mg) 1 month prior to the surgery date
Group 3: oral dienogest 2mg daily will be given to be taken for 30 days
A laparoscopic cystectomy will be performed 1 month after the initiation of the above treatment. After the operation all participants are also assessed regarding overall satisfaction of the treatment that they have received.
Randomisation is made by computerised block randomisation. Patient will pick 1 out of 3 sealed envelope the patient is not blinded by the treatment that they will receive, the surgeon however will not be made aware of the treatment received by their patient.
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Primary Outcome(s)
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1. Feasibility of cyst extraction intraoperatively (rating: easy/moderate/difficult)
2. Duration of surgery (recorded in minutes)
2. Patient satisfaction with the post operative pain relief using a visual analogue score
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Secondary Outcome(s)
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Intraoperative blood loss in millilitres. Outcome will be retrieved from the surgical notes, anaesthetists notes on or after hospital discharge.
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Secondary ID(s)
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NMRR-16-317-29736
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Source(s) of Monetary Support
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University Malaya Medical Centre
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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