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

Completed

• Conditions: Endometrial Polyp

• Registration Number: NCT05337605
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

Inclusion Criteria

• participation in earlier study

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, noord-Brabant, Netherlands