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    Clinical Trial Results:
    A randomised controlled trial to investigate the effects of the use of pre-operative GnRH analogue and intra-operative mechanical tourniquet for myomectomy on surgical blood loss, future fertility and quality of life

    Summary
    EudraCT number
    		 2010-019810-26
    Trial protocol
    		 GB  
    Global end of trial date
    05 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2021
    First version publication date
    01 Jan 2021
    Other versions
    Summary report(s)
    		 Clinical Study report

    Trial information

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    Trial identification
    Sponsor protocol code
    1968
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Mr Nitish Narvekar, Kings College Hospital Foundation NHS Trust, +44 020 3299 5390, nitish.narvekar@nhs.net
    Scientific contact
    Mr Nitish Narvekar, Kings College Hospital Foundation NHS Trust, +44 020 3299 5390, nitish.narvekar@nhs.net
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Sep 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the clinical efficacy and cost-effectiveness of pre-operative use of GnRH analogues and intra-operative use of mechanical tourniquet in reducing intra-operative blood loss
    Protection of trial subjects
    Patients will be able to withdraw their consent to taking part in the trial at any point. This will be discussed with them at every clinic visit. If they decide to withdraw as they are patients at Kings College Hospital they will continue to be followed up as per routine patient care. If they withdraw due to an adverse event then they will be followed up until the end of the trial or until the event is resolved (which ever is sooner).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 73
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    73
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 73 subjects were recruited in total between April 2012 and April 2019 from King's College Hospital, London.

    Pre-assignment
    Screening details
    		 Women were eligible if they were diagnosed with uterine fibroids on ultrasonography, opted for surgery and considered suitable for an open myomectomy by a consultant gynaecologist. Eligibility included women between ages 18-50 years, with a uterine size of over 14 weeks gestational equivalence and/or volume of over 600cm3.

    Pre-assignment period milestones
    Number of subjects started
    		 73
    Number of subjects completed
    		 43

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 30
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study is not blinded however patients will be asked not to reveal to their allocation to their surgeon, in addition they will carry a card detailing their treatment allocation details. The allocation will be recorded in the notes but stored in an envelope to avoid the surgeon being un-blinded. Surgeons in Group A will be un-blinded to patient allocation. Surgeons in groups B and C will be blinded and will be unaware if the subject has had pre operative GnRH analogue.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A GnHR
    Arm description
    		 Patients allocated to use of pre-operative GnRH analogues will be prescribed Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    prosrap SR DCS
    Investigational medicinal product code
    Other name
    LEUPRORELIN ACETATE
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery. Total dose of 11.25mg over 3 months.

    Arm title
    		 B Tourniquet
    Arm description
    		 intra-operative mechanical tourniquet only
    Arm type
    		 surgical intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 C GnHR and Tourniquet
    Arm description
    		 Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery and intra-operative mechanical tourniquet
    Arm type
    		 Experimental

    Investigational medicinal product name
    prosrap SR DCS
    Investigational medicinal product code
    Other name
    LEUPRORELIN ACETATE
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery. Total dose of 11.25mg over 3 months.

    Number of subjects in period 1 [1]
    		A GnHR B Tourniquet C GnHR and Tourniquet
    Started
    14
    12
    17
    Completed
    14
    12
    17
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 30 withdrew or were lost to follow up prior to staring the intervention

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    A GnHR
    Reporting group description
    		 Patients allocated to use of pre-operative GnRH analogues will be prescribed Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery.

    Reporting group title
    B Tourniquet
    Reporting group description
    		 intra-operative mechanical tourniquet only

    Reporting group title
    C GnHR and Tourniquet
    Reporting group description
    		 Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery and intra-operative mechanical tourniquet

    Reporting group values
    		 A GnHR B Tourniquet C GnHR and Tourniquet Total
    Number of subjects
    		 14 12 17 43
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.8 ( 4.7 ) 39.8 ( 5.1 ) 41.1 ( 4.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 12 17 43
        Male
    		 0 0 0 0
    ethnicity
    Units: Subjects
        white
    		 1 0 1 2
        black
    		 12 12 16 40
        asian
    		 1 0 0 1
    Anaemia
    Hb<12g/L
    Units: Subjects
        Hb<12g/L
    		 2 5 1 8
        Hb>12g/L
    		 12 7 16 35
    Parity
    Units: Subjects
        No previous births
    		 11 9 14 34
        >= 1 birth
    		 3 3 3 9
    smoking status
    Units: Subjects
        smoker
    		 1 0 2 3
        non-smoker
    		 13 12 15 40
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 29 ( 4.4 ) 30.9 ( 4 ) 29.8 ( 4.3 ) -

    End points

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    End points reporting groups
    Reporting group title
    A GnHR
    Reporting group description
    		 Patients allocated to use of pre-operative GnRH analogues will be prescribed Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery.

    Reporting group title
    B Tourniquet
    Reporting group description
    		 intra-operative mechanical tourniquet only

    Reporting group title
    C GnHR and Tourniquet
    Reporting group description
    		 Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery and intra-operative mechanical tourniquet

    Primary: mean blood loss

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    End point title
    		 mean blood loss [1]
    End point description
    Evaluation of Blood loss: Special drapes will be placed in the abdomen to collect blood during surgery. The collected blood will be suctioned continuously into a cell saver apparatus for measurement and auto-transfusion if appropriate. Blood absorbed by surgical swabs will be estimated using dry and swab weight differential measurement using the appropriate conversion factor. Blood collected in any post-operative drains, which are used per clinical need, will be measured to compute the total peri-operative blood loss.
    End point type
    Primary
    End point timeframe
    In operative
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see linked summary report
    End point values
    		 A GnHR B Tourniquet C GnHR and Tourniquet
    Number of subjects analysed
    14
    12
    17
    Units: ml
        arithmetic mean (standard deviation)
    1210 ( 965 )
    458 ( 387 )
    406 ( 285 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Participants in Group A (GnHR) & C (GnHR + tourniquet) were asked questions regarding any adverse events at their monthly visits 3 months pre-operation. All subjects were reviewed for AEs at their pre-admission visit and whilst inpatients.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    A GnHR
    Reporting group description
    		 Patients allocated to use of pre-operative GnRH analogues will be prescribed Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery.

    Reporting group title
    B Tourniquet
    Reporting group description
    		 intra-operative mechanical tourniquet only

    Reporting group title
    C GnHR and Tourniquet
    Reporting group description
    		 Prostap (Leuprorelin acetate depot injection, Takeda, UK) as a single dose of 3.75 mg by intramuscular or subcutaneous injection every 28 days, 3 months prior to surgery and intra-operative mechanical tourniquet

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Any medical occurrences which occurred resulted in a prolonged hospital stay/additional hospital stay - and so these were all reported as an SAE.
    Serious adverse events
    		 A GnHR B Tourniquet C GnHR and Tourniquet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 A GnHR B Tourniquet C GnHR and Tourniquet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 17 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 May 2012
    Change of IMP formulation from Prostap SR to Prostap SR DCS due to change in formulation by manufacturer. Clarification of route of administration (Intramuscular or Subcutaneous) Clarification of Eligibility criteria and safety reporting requirements (no new criteria just clarification of existing). Clarification of endpoint and statistical requirements (No new information). Administrative changes to protocol wording.
    13 Sep 2018
    Protocol was updated to remove secondary endpoints and associated procedures. This trial will now focus on collecting primary endpoint data only.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Limitations include lower than required number of participants due to a prolonged trial time,changeover of research teams & significant follow up required over the years.Secondary outcomes could not be measured nor impact on QoL.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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