None listed
Conditions
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.
Interventions
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 cond
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.
Sponsors
Mercy Hospital for Women
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Exclusion criteria
1. Non-English speaking or inadequate English literacy 2. Contraindications to operative hysteroscopy
Outcome results
None listed