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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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