Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results

In this study, a comparison is made between two types of polyp resection methods (hand driven and motor driven morcellation). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps.

The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.

Study Overview

• Status: Completed
• Conditions: Endometrial Polyp

Detailed Description

• Rationale: several techniques for hysteroscopic removal of intrauterine polyps exist today. Hysteroscopic morcellation is an effective, fast, and safe method for this. However, the differences between two different systems of hysteroscopic morcellation, motor-driven (Truclear incisor mini device) and hand-driven (Resectr 9fr) morcellation, are still unclear. The REMOvE9 study, in which women with a polyp were randomized between both techniques, is currently investigating the differences in short-term effectiveness between the two techniques.
• Research question/goal: To investigate the long-term results of the effectiveness of a hysteroscopic morcellation of intrauterine polyps. The two systems are compared with each other.
• Study design: This is a prospective cohort study. The patients previously participated in a randomized controlled trial (REMOvE9) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
• Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in the REMOvE9 study.
• Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Netherlands
  • noord-Brabant
    • Eindhoven, noord-Brabant, Netherlands, 5623 EJ
      • Catharina Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women treated for endometrial polyps in earlier study

Description

Inclusion Criteria:

• participation in earlier study

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hand driven tissue removal system; Endometrial polyp removed by hysteroscopic hand-driven tissue removal system in a previous study.
Motor driven tissue removal system; Endometrial polyp removed by hysteroscopic motor-driven tissue removal system in a previous study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4 years
Recurrence interval (time to recurrence of endometrial polyp)	Patient reported outcome by means of a questionnaire (when did blood loss occur / when was polyp identified)	1 to 4years
Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)	Patient reported outcome by means of a questionnaire	1 to 4years
Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4years
Rate of occurrence of new polyps (+ cause, treatment)	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4years
Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)	Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)	1 to 4years
General satisfaction score in regard to initial treatment	Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)	1 to 4years
Rate of need for additional treatment	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4years
Chance of pregnancy after treatment	Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.	1 to 4 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Tjalina Hamerlynck, Md, Phd, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BC-11626 BC-11627 BC-11628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No