The hand driven hysteroscopic tissue removal system (Resectr 9Fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: A randomized controlled trail.

The hand driven hysteroscopic tissue removal system (Resectr 9Fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: A randomized controlled trail. - Comparison of hand and motor driven hysteroscopic removal systems

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55576

Enrollment

Registered

2019-04-25

Start date

2018-04-02

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

benign uterine growth polyp

Interventions

Hystroscopisic tissue removal (polyp removal)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with one or more intrauterine polyps (largest diameter >=8 mm -

Exclusion criteria

Exclusion criteria: Patients with: • Polyps 20mm • Myomas • Visual or pathological (e.g. on biopsy) evidence of malignancy preoperatively or at the time of operation. • Untreated cervical stenosis making safe access for operative hysteroscopy impossible as diagnosed preoperatively or at the time of operation • A contra-indication for operative hysteroscopy. • Significant language barrier

Design outcomes

Primary

Measure	Time frame
Installation time and resection/ operating time.	—

Secondary

Measure	Time frame
Fluid deficit, conversion rates, peri- and postoperative complications, availability of tissue for pathology, persistence of symptoms (e.g. menorrhagia) and/or intrauterine abnormalities at 6 weeks follow-up, pain scores and evaluation of surgeons convenience during procedures.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)