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Trial registered on ANZCTR


Registration number
ACTRN12623000967684
Ethics application status
Approved
Date submitted
4/04/2023
Date registered
6/09/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Hysteroscopic Morcellation vs Bipolar Resection for Retained Products of Conception (RPOC): A Pilot Randomised Control Trial
Scientific title
Hysteroscopic Morcellation vs Bipolar Resection for Retained Products of Conception (RPOC): A Pilot Randomised Control Trial
Secondary ID [1] 308929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retained products of conception 328934 0
Condition category
Condition code
Reproductive Health and Childbirth 325921 325921 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Operative hysteroscopy with MyoSure XL (Hologic, Inc) intrauterine morcellation to surgically evacuate retained products of conception from the uterus
- this will involve a GA procedure (standard) and hysteroscopic access to the uterus. The Myosure XL device is then used to remove pregnancy tissue under vision.
- For the purpose of the study, the procedure will only be performed once. One of the study outcomes is incomplete tissue removal. If clinically indicated, a repeat procedure will be conducted, and outcomes of this will be noted as a complication of treatment.
- A gynaecological surgeon or trainee surgeon (supervised) will be performing the intervention.
- No additional training will be undertaken - all participating surgeons will have previously had training in the device, and have performed at least 10 prior procedures.
- The procedure will take approximately 10-30minutes.
Intervention code [1] 325370 0
Treatment: Surgery
Comparator / control treatment
Operative hysteroscopy with bipolar loop resection to surgically evacuate retained products of conception from the uterus
- this is the standard hysteroscopic removal procedure where a bipolar loop electrode, connected down the operating channel of an operative hysteroscopy, is used to 'under vision' remove the tissue products. This is usually achieved 'cold' where to cutting power is used, but rather a visualised lifting of the products. Power (bipolar current) is used if bleeding is problematic or tissue will not peel off.
- A gynaecological surgeon or trainee surgeon (supervised) will be performing the intervention.
- The procedure will take approximately 10-30minutes.
Control group
Active

Outcomes
Primary outcome [1] 334381 0
Study feasibility: participant consent rate (number/%)
- gained from audit of study enrolment data
Timepoint [1] 334381 0
6months following procedure
Primary outcome [2] 334382 0
Study feasibility: collection rate of complete intraoperative data (%)
- gained from audit of study case report forms
Timepoint [2] 334382 0
6months following procedure
Primary outcome [3] 334383 0
Study Feasibility: collection rate of complete post-operative data (%)
- gained from audit of study case report forms
Timepoint [3] 334383 0
6months post procedure
Secondary outcome [1] 420447 0
Success rate of assigned surgical therapy (%)
- as determined by a composite of: surgeon report of completeness of evacuation, resolution of symptoms, avoidance of further surgical or medical interventions (from study report forms)
Timepoint [1] 420447 0
6months post procedure
Secondary outcome [2] 420449 0
Median set-up time (mins)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)
Timepoint [2] 420449 0
6months post procedure.
Secondary outcome [3] 420450 0
Median operative time (mins)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)
Timepoint [3] 420450 0
6months post procedure
Secondary outcome [4] 420451 0
Median fluid deficit (mL)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)
Timepoint [4] 420451 0
6months post procedure
Secondary outcome [5] 420452 0
Rate of Surgical Complications : uterine perforation, fluid overload, electrolyte disturbances, bleeding, burns, gas embolism, infection, conversion, laparoscopy/laparotomy
- gained from intra-operatives study report form (completed by nurse assistant during procedure.), plus post-op study report form (patient and clinician report) and file review
Timepoint [5] 420452 0
6months post procedure
Secondary outcome [6] 420453 0
Rate of requirement for further management (%)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.), plus post-op study report form (patient and clinician report) and file review
Timepoint [6] 420453 0
6months post procedure
Secondary outcome [7] 420454 0
Mean patient quality of life: assessed using the EQ-5D and EQ-VAS tool.
- these are two pages/tools within the EQ-5D-5L. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS
Timepoint [7] 420454 0
2weeks, 3months, 6months post procedure

Eligibility
Key inclusion criteria
1. Women with RPOC as identified on pelvic ultrasound performed at the study institution (Mercy Hospital for Women) or a scan performed by an expert ultrasonologist with COGU (certificate of Obstetrics and Gynaecological Ultrasound) qualifications.
These ultrasound inclusion criteria are:
a) >3ml echogenic material with vasculature into the mass, and/or
b) Greatest diameter of RPOC >18mm
c) Endometrial thickness AP diameter >18mm
2. Women who meet the institution-based criteria for surgical management with operative hysteroscopy
a) >15 days post-partum
b) >30days post miscarriage/termination
3. Women aged over 18 years of age at the time of surgery
4. The surgeon has deemed that hysteroscopic removed is indicated AND the surgeon is accredited in both techniques
5. Participant understands the conditions of the study and are willing to participate for the duration of study including all follow-up.
6. Participant is capable of, and have given, informed consent to their participation in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speaking or inadequate English literacy
2. Contraindications to operative hysteroscopy

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 not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Participant characteristics will be reported as a mean ± standard deviation, n (%), or median (interquartile range [25%–75%]). For normal distributed variables the student t test will be used. While in non-normally distributed continuous variables the Mann Whitney U test will be used. Categoric data will be examined for frequency and percentage per study arm and analysed using the Fisher exact test. If time variables are skewed then they will be log-transformed and analysed with the Student t test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
13/03/2024
Date of last participant enrolment
Anticipated
2/08/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24477 0
Mercy Hospital for Women - Heidelberg
Recruitment postcode(s) [1] 40061 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 313138 0
Charities/Societies/Foundations
Name [1] 313138 0
Australian Gynaecological Endoscopy & Surgery Society
Country [1] 313138 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 314839 0
None
Name [1] 314839 0
Address [1] 314839 0
Country [1] 314839 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312382 0
Mercy Hospital For Women
Ethics committee address [1] 312382 0
163 Studley Road, Heidelberg VIC 3084
Ethics committee country [1] 312382 0
Australia
Date submitted for ethics approval [1] 312382 0
Approval date [1] 312382 0
29/08/2022
Ethics approval number [1] 312382 0
MHW HREC 2021-061

Summary
Brief summary
Rationale: Retained products of conception (RPOC) is the presence of fetal and/or placental tissue within the uterus post-delivery (preterm or term), miscarriage or termination. It has a prevalence of 0.5-19% and is most commonly seen after second trimester delivery and termination of pregnancy.
Most women with RPOC are symptomatic with uterine bleeding, pelvic pain, fevers and/or uterine tenderness, however, some can be initially asymptomatic and have delayed issues such as amenorrhea and infertility from intra-uterine adhesions. For this reason effective treatment for the management of RPOC is important.
There are currently no comparative papers assessing medical versus surgical management of retained products of conception. Often patients trial expectant or medical management, but this is unsuccessful in about 20% of cases. The two main surgical options are dilatation and curettage (D&C) or operative hysteroscopy with resectoscopic techniques. The advantage of an operative hysteroscopy over a dilatation and curettage is that it allows for selective resection under direct vision and is therefore beneficial when other methods have failed, there is a significant amount/vascular RPOC, or there are concerns about interruption or damage to surrounding endometrium. Unfortunately, a systematic review by our group, concluded that the current evidence was inadequate to confirm one surgical technique superior to the other.
Hysteroscopic morcellation has been increasingly used in management of intra-uterine pathology, however, only one study by Hamerlynck et al has compared it to bipolar resection in the management of RPOC, specifically with the use of the TruClear (Medtronic). The TruClear device is not available in Australia.
This pilot aims to assess the feasibility of our study design, and provide data to allow sample size calculation for the larger study.

Objectives:
The overall objective of the future full study is to compare operative hysteroscopy with MyoSure XL (Hologic, Inc) intrauterine morcellation to bipolar loop resection in the management of RPOC, in terms of both short-term (surgical efficiency and safety) and long-term outcomes (fertility outcomes). The null hypothesis is that there will be no difference in outcomes. However, we need the pilot data prior to plan this final study, hence this proposed pilot.

Methodological Approach:
An open label, pilot randomised control trial at Mercy Hospital for Women, a tertiary hospital in Melbourne, Australia. Mercy serves as a referral hospital for operative hysteroscopic management of RPOC.
Hysteroscopic morcellation has had good outcomes in the resection of intrauterine pathology (such as fibroids and polyps) and has therefore increasingly also been used in women with RPOC.
The more traditionally used method is resection with a bipolar resectoscope; therefore, this will be the choice for the control arm.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124462 0
Dr Samantha Mooney
Address 124462 0
Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084
Country 124462 0
Australia
Phone 124462 0
+61 3 84584022
Fax 124462 0
+61 3 84584889
Email 124462 0
smooney@mercy.com.au
Contact person for public queries
Name 124463 0
Dr Samantha Mooney
Address 124463 0
Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084
Country 124463 0
Australia
Phone 124463 0
+61 3 84584022
Fax 124463 0
+61 3 84584889
Email 124463 0
smooney@mercy.com.au
Contact person for scientific queries
Name 124464 0
Dr Samantha Mooney
Address 124464 0
Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084
Country 124464 0
Australia
Phone 124464 0
+61 3 84584022
Fax 124464 0
+61 3 84584889
Email 124464 0
smooney@mercy.com.au

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.