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Placental remnants curettage hysteroscopic morcellation trial

Surgical treatment of placental remnants: hysteroscopic morcellation versus ultrasound guided electric vacuum aspiration, a multicenter randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27293
Enrollment
140
Registered
2014-11-23
Start date
2015-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

placental remnants retained products of pregnancy residual trophoblastic tissue retained products of conception retained placental tissue hysteroscopy hysteroscopic morcellation vacuum aspiration

Interventions

hysteroscopic morcellation ultrasound guided electric vacuum aspiration

Sponsors

Catharina Hospital Eindhoven Ghent University Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age at least 18 years - Ultrasonographic findings: image suggestive for placental remnants ranging from 1 to 4 cm in diameter - Willing to give informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Placental remnants with a maximum diameter smaller than 1 cm or more than 4 cm - Patients presenting with fever - Visual or pathological (e.g. on biopsy) evidence of malignancy preoperatively or at the time of operation - Untreated cervical stenosis making safe uterine access impossible as diagnosed preoperatively by ambulant hysteroscopy - A contra-indication for surgery

Design outcomes

Primary

MeasureTime frame
Intrauterine adhesions diagnosed by second look hysteroscopy after at least 1 menstruation or a period of minimum 8 weeks after the operation.

Secondary

MeasureTime frame
- Installation and operating time - Conversion rates - Peri- and postoperative complications (e.g. excessive fluid deficit in case of hysteroscopy, perforation, hemorrhage, postoperative infection) - Availability of tissue for pathology analysis and pathology results - Completeness of removal at second look hysteroscopy - Persistence of symptoms - Necessity for additional treatment - Subsequent reproductive and pregnancy outcome

Contacts

Public ContactT. Hamerlynck

Women’s Clinic Ghent University Hospital De Pintelaan 185, 9000 Gent, Belgium

Tjalina.Hamerlynck@ugent.be+32 9 332 28 43

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)