Clinical evaluation of a new hand driven hysteroscopic tissue removal device, Resectr 5fr, for the resection of endometrial polyps in an office setting.

Prospective study during implementation of a hand driven hysteroscopic tissue removal system (Resectr® 5.0 fr) for removal of polyps

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23197

Enrollment

112

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

Hysteroscopic polypectomy using the hand driven tissue removal device Resectr® 5.0 fr. in an office setting without anesthesia

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 18 years or older, with one or more intrauterine polyp (mean diameter 8mm or smaller) as seen on ultrasound, saline infusion sonography and/or ambulant diagnostic hysteroscopy who are planned for hysteroscopic surgery in an outpatient setting.

Exclusion criteria

Exclusion criteria: • Polyps > 8 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
Installation and resection time (of the largest polyp)	—

Secondary

Measure	Time frame
o Surgeon’s convenience on a 5-point Likert scale o Patient’s pain and satisfaction score on a 5-point Likert scale o Intra- and postoperative complications (fluid deficit, blood loss (= 500ml), uterine perforation, infection) o Completeness of resection (separation and extraction of all visible polyp tissue) o Short term effectiveness (persistence of symptoms at 6 week follow-up) o Postoperative availability of tissue for pathology analysis and pathology diagnosis	—

Measure

Time frame

o Surgeon’s convenience on a 5-point Likert scale o Patient’s pain and satisfaction score on a 5-point Likert scale o Intra- and postoperative complications (fluid deficit, blood loss (= 500ml), uterine perforation, infection) o Completeness of resection (separation and extraction of all visible polyp tissue) o Short term effectiveness (persistence of symptoms at 6 week follow-up) o Postoperative availability of tissue for pathology analysis and pathology diagnosis

—

Contacts

Public ContactDick Schoot

Catharina Hospital, Eindhoven

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

Outcome results