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

Endometrial Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05337605
• Other study ID #: BC-11626 BC-11627 BC-11628
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: November 8, 2022

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• participation in earlier study

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Endometrial Polyp

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven	noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of occurrence of new polyps (+ cause, treatment)	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4years
Secondary	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
Secondary	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
Secondary	Rate of need for additional treatment	Patient reported outcome by means of a questionnaire (yes/no, specify)	1 to 4years
Secondary	Chance of pregnancy after treatment	Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.	1 to 4 years