Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
1 other identifier
observational
44
1 country
1
Brief Summary
In this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2022
CompletedSeptember 26, 2023
September 1, 2023
6 months
April 4, 2022
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years
Secondary Outcomes (9)
Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)
8 to 10 years
Recurrence interval (time to recurrence of endometrial polyp)
8 to 10 years
Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)
8 to 10 years
Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)
8 to 10 years
Rate of occurrence of new polyps (+ cause, treatment)
8 to 10 years
- +4 more secondary outcomes
Study Arms (2)
Tissue removal system
Endometrial polyp removed by hysteroscopic tissue removal system in a previous study.
Bipolar resectoscopy
Endometrial polyp removed by hysteroscopic bipolar resectoscopy in a previous study.
Eligibility Criteria
Women treated for endometrial polyps in earlier study.
You may qualify if:
- participation in earlier study
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catharina ziekenhuis
Eindhoven, North Brabant, 5623 EJ, Netherlands
Related Publications (1)
Hamerlynck TW, Blikkendaal MD, Schoot BC, Hanstede MM, Jansen FW. An alternative approach for removal of placental remnants: hysteroscopic morcellation. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):796-802. doi: 10.1016/j.jmig.2013.04.024.
PMID: 24183271RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Tjalina Hamerlynck, Md, Phd
University Hospital, Ghent
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 20, 2022
Study Start
April 1, 2022
Primary Completion
September 27, 2022
Study Completion
September 27, 2022
Last Updated
September 26, 2023
Record last verified: 2023-09