Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results

September 25, 2023 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Detailed Description

  • Rationale: Several techniques for hysteroscopic removal of intrauterine polyps exist today. Up until the first decade of this century, larger polyps were usually removed via bipolar resectoscopy. Later, the hysteroscopic tissue removal system (morcellation) was introduced in which the abnormal tissue is mechanically removed, which is then immediately aspirated. Previous studies comparing bipolar resection and morcellation show that this is an effective, fast, and safe method without major complications. However, the long-term results are still largely unknown.
  • Research question/goal: To investigate the long-term results of the effectiveness of hysteroscopic removal of intrauterine polyps. Bipolar resection and morcellation are compared here.
  • Study design: This is a prospective cohort study. The patients previously participated in a randomized study (2011-2014) 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 a previous 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)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years
Recurrence interval (time to recurrence of endometrial polyp)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (when did blood loss occur / when was polyp identified)
8 to 10 years
Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire
8 to 10 years
Rate of occurrence of new symptoms after initial intervention (abdominal pain, abnormal uterine blood loss, infections, other...) (+ cause, treatment)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years
Rate of occurrence of new polyps (+ cause, treatment)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years
Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)
8 to 10 years
General satisfaction score in regard to initial treatment
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire on a scale from 0 (bad) to 5 (great)
8 to 10 years
Rate of need for additional treatment
Time Frame: 8 to 10 years
Patient reported outcome by means of a questionnaire (yes/no, specify)
8 to 10 years
Chance of pregnancy after treatment
Time Frame: 8 to 10 years
Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.
8 to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

September 27, 2022

Study Completion (Actual)

September 27, 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)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • BC-11629 BC-11630 BC-11631

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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