Endometrial PolypNCT05337046
Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
An observational study of Endometrial Polyp, run by University Hospital, Ghent at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Polyp
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2022to 27 Sep 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women treated for endometrial polyps in earlier study.
Who may be able to join
- participation in earlier study
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Endometrial Polyp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment)
Patient reported outcome by means of a questionnaire (yes/no, specify)
Measured: 8 to 10 years
Secondary outcomes (9)
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)
Measured: 8 to 10 years
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)
Measured: 8 to 10 years
Number of patients with symptom relief after initial intervention (abdominal pain, abnormal uterine blood loss, other...)
Patient reported outcome by means of a questionnaire
Measured: 8 to 10 years
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)
Measured: 8 to 10 years
Rate of occurrence of new polyps (+ cause, treatment)
Patient reported outcome by means of a questionnaire (yes/no, specify)
Measured: 8 to 10 years
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)
Measured: 8 to 10 years
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)
Measured: 8 to 10 years
Rate of need for additional treatment
Patient reported outcome by means of a questionnaire (yes/no, specify)
Measured: 8 to 10 years
Chance of pregnancy after treatment
Only applicable for women with fertility problems, Patient reported outcome by means of a questionnaire.
Measured: 8 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjalina Hamerlynck, Md, Phd, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337046
- Sponsor's protocol ID
- BC-11629 BC-11630 BC-11631
- Status last verified
- Sep 2023
- First submitted
- 4 Apr 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24183271
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results
- ClinicalTrials.gov ID
- NCT05337046
- Acronym / sponsor ID
- BC-11629 BC-11630 BC-11631
- Conditions
- Endometrial Polyp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women treated for endometrial polyps in earlier study.
Key inclusion criteria (1 listed)
- participation in earlier study
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
9 secondary outcomes
Rate of recurrence of other symptoms (abdominal pain, infections, back pain, other..) (+ cause, treatment)
Time frame: 8 to 10 years
Recurrence interval (time to recurrence of endometrial polyp)
Time frame: 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
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
Rate of occurrence of new polyps (+ cause, treatment)
Time frame: 8 to 10 years
Satisfaction score in regard to symptoms (abdominal pain, abnormal uterine blood loss, other...)
Time frame: 8 to 10 years
General satisfaction score in regard to initial treatment
Time frame: 8 to 10 years
Rate of need for additional treatment
Time frame: 8 to 10 years
Chance of pregnancy after treatment
Time frame: 8 to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Results publication: PubMed 24183271Hamerlynck 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.
- Individual participant dataSharing planned: Undecided
Related trials for Endometrial Polyp
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
RecruitingObservational study
Discovering New Targets for Colorectal and Endometrial Cancer Risk Reduction
Colorectal Cancer, Endometrial Cancer
Not yet recruiting
Yiwu Cold Knife Technique Versus Electrocision for Multiple Endometrial Polyps
Yiwu Cold Knife Technique for Multiple Endometrial Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjalina Hamerlynck, Md, Phd principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Polyp, run by University Hospital, Ghent at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrence of abnormal uterine blood loss (+ cause, treatment) (time frame: 8 to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.