Clinical trial NCT05337605: Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results
Official title: Hand Driven Versus Motor Driven Hysteroscopic Tissue Removal System for Polypectomy: Long-term Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Polyp
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women treated for endometrial polyps in earlier study

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).

Eligibility criteria: Inclusion Criteria:

* participation in earlier study

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
timeFrame: 1 to 4 years
Secondary outcomes:
measure: Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)
timeFrame: 1 to 4 years
measure: Recurrence interval (time to recurrence of endometrial polyp)
timeFrame: 1 to 4years
measure: Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)
timeFrame: 1 to 4years
measure: Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)
timeFrame: 1 to 4years
measure: Rate of occurrence of new polyps (+ cause, treatment)
timeFrame: 1 to 4years
measure: Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)
timeFrame: 1 to 4years
measure: General satisfaction score in regard to initial treatment
timeFrame: 1 to 4years
measure: Rate of need for additional treatment
timeFrame: 1 to 4years
measure: Chance of pregnancy after treatment
timeFrame: 1 to 4 years
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: noord-Brabant
Study officials:
affiliation: University Hospital, Ghent
name: Tjalina Hamerlynck, Md, Phd
role: PRINCIPAL_INVESTIGATOR
References: