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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Retained products of conception

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Study feasibility: participant consent rate (number/%)
- gained from audit of study enrolment data

Timepoint [1]

6months following procedure

Primary outcome [2]

Study feasibility: collection rate of complete intraoperative data (%)
- gained from audit of study case report forms

Timepoint [2]

6months following procedure

Primary outcome [3]

Study Feasibility: collection rate of complete post-operative data (%)
- gained from audit of study case report forms

Timepoint [3]

6months post procedure

Secondary outcome [1]

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]

6months post procedure

Secondary outcome [2]

Median set-up time (mins)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)

Timepoint [2]

6months post procedure.

Secondary outcome [3]

Median operative time (mins)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)

Timepoint [3]

6months post procedure

Secondary outcome [4]

Median fluid deficit (mL)
- gained from intra-operatives study report form (completed by nurse assistant during procedure.)

Timepoint [4]

6months post procedure

Secondary outcome [5]

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]

6months post procedure

Secondary outcome [6]

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]

6months post procedure

Secondary outcome [7]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Mercy Hospital for Women - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Gynaecological Endoscopy & Surgery Society

Address [1]

YRD Event Management
PO Box 717
Indooroopilly QLD 4068
AUSTRALIA

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mercy Hospital for Women

Address

163 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mercy Hospital For Women

Ethics committee address [1]

163 Studley Road, Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/08/2022

Ethics approval number [1]

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

Dr Samantha Mooney

Address

Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084

Country

Australia

Phone

+61 3 84584022

Fax

+61 3 84584889

[email protected]

Contact person for public queries

Name

Samantha Mooney

Address

Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084

Country

Australia

Phone

+61 3 84584022

Fax

+61 3 84584889

[email protected]

Contact person for scientific queries

Name

Samantha Mooney

Address

Mercy Hospital for WomenLevel 6, 163 Studley RoadHeidelberg VIC 3084

Country

Australia

Phone

+61 3 84584022

Fax

+61 3 84584889

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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