Comparison of hand or motor driven hysteroscopic removal systems

The hand driven hysteroscopic tissue removal system (Resectr® 9.0 fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: a randomized controlled non-inferiority trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21102

Enrollment

140

Registered

2018-03-27

Start date

2018-09-01

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

None listed

Interventions

-Group 1: removal of intrauterine polyps with Truclear hysteroscopic morcellator -Group 2: removal of intrauterine polyps with Resectr hysteroscopic morcellator

Eligibility

Inclusion criteria

Inclusion criteria: - endometrial polyps largest diameter =8mm - =20 mm - intrauterine polyps confirmed by ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy

Exclusion criteria

Exclusion criteria: • Polyps largest diameter smaller than 8 mm • Polyps largest diameter larger than 20 mm • 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 • Pregnant women

Design outcomes

Primary

Measure	Time frame
Primary Objective: Comparing installation and operating time between the Truclear HM device and the Resectr® 9.0 fr HM device for removal of intrauterine large polyps.	—

Secondary

Measure	Time frame
Secondary Objective(s): Comparing data on procedure time, peri- and postoperative complications (e.g. fluid deficit, conversion rates, perforation), postoperative availability of tissue for pathology analysis and pathology diagnosis, pain scores, evaluation of surgeons convenience during procedures and efficiency (completeness of resection and persistence of symptoms or abnormalities at 6 weeks follow-up).	—

Measure

Time frame

Secondary Objective(s): Comparing data on procedure time, peri- and postoperative complications (e.g. fluid deficit, conversion rates, perforation), postoperative availability of tissue for pathology analysis and pathology diagnosis, pain scores, evaluation of surgeons convenience during procedures and efficiency (completeness of resection and persistence of symptoms or abnormalities at 6 weeks follow-up).

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Contacts

Public ContactDick Schoot

Catharina Hospital Eindhoven

Dick@schoot.com+31 6 51 54 70 41

Outcome results