Endometrial PolypsNCT02126397
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
A study testing polyps resection with Laser Diode and polyps resection with bipolar electrode in people with Endometrial Polyps, run by Isabel Bejerano Blázquez at 2 sites in Spain.
Trial summary
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. In recent years we have used the bipolar energy for resection of polyps by hysteroscopy, becoming a routine clinical practice and universally accepted. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Polyps
- What is being tested?
- polyps resection with Laser Diode and polyps resection with bipolar electrode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesSpain
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients previously diagnosed of endometrial polyps that can be resected. The diagnosis will be made hysteroscopically. The patient must be informed about the study, and sign the informed consent.
Who cannot join
- the usual exclusion criteria for surgical techniques, pregnant patients, patiens under 18 patients who did not sign the informed consent
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Reina Sofia University Hospital
Córdoba, Cordoba, 14004
Reina Sofía University Hospital
Córdoba, Cordoba, 14004
About this study
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. In recent years we have used the bipolar energy for resection of polyps by hysteroscopy, becoming a routine clinical practice and universally accepted.
Resection of endometrial polyps laser energy has recently begun to be used with satisfactory results, so studies are needed to analyze these results and compare it with the usual techniques .
Read more
This time in advance of medicine, it is appropriate to introduce minimally invasive procedures , allowing resection of endometrial polyps on an outpatient basis without anesthesia and acceptable to most patients.
These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .
Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
Read the detailed description
Main objective: To assess the tolerability of diode laser in the treatment of endometrial polyps using a visual analogue pain scale.
Secondary objectives:
- Determine if complete resection of polyps is achieved with both methods.
- Compare the time spent on the removal of the polyp in each of the hysteroscopic methods.
- To evaluate the safety of the laser diode with respect to the bipolar electrode (vagal syndrome, uterine perforation, infection, bleeding).
- Assess the recurrence of polyps after 3 months of resection (via hysteroscopy).
- Compare the degree of patient satisfaction with the different methods.
Design: randomized single blind clinical trial corresponds to an experimental analytical study. The patients randomly into 2 groups will include: Group A bipolar electrode treatment Versapoint and Group B diode laser treatment. Randomization was performed using a random table with 2 groups, generated in Microsoft Office Excel. The sample size needed to detect a difference in visual analog pain scale of a point with respect to the laser diode bipolar electrode is calculated; assuming a standard deviation of 1.75, a sample size of 49 patients in each group (98 would be needed in total), to a level of significance of 5% (0.05 α) with a power of 0.80 (beta 0.20). Assuming a loss of individuals from 5 to 10%
- Conditions
- Endometrial Polyps
- Being tested
- polyps resection with Laser Diode, polyps resection with bipolar electrode
- Keywords
- endometrial polyp, resection of endometrial polyps, hysteroscopy, bipolar electrode Versapoint, Laser Diode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyps resection with Laser DiodeProcedure or surgery
resection of endometrial polyps by hysteroscopy without anesthesia
polyps resection with bipolar electrodeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| polyps resection with Laser Diode | Active comparator | application of the laser diode by hysteroscopy to remove the endometrial polyp Receives: Procedure: polyps resection with Laser Diode |
| polyps resection with bipolar electrode | Active comparator | application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp Receives: Procedure: polyps resection with bipolar electrode |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale
Measured: we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Secondary outcomes (3)
Determine if complete resection of polyps is achieved with both methods.
Measured: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Compare the time spent on the removal of the polyp.
Measured: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
To evaluate the safety of both methods
Measured: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PolypsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabel Bejerano Blázquez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Universidad Nacional de Córdoba
- Responsible party
- Sponsor-investigator, Isabel Bejerano Blázquez, Maimónides Biomedical Research Institute of Córdoba
- Investigators
- José Eduardo Arjona Berral, Gynecologist, Study director, Head of the Department of Obstetrics and Gynecology at the University Hospital Reina SofiaMaria Dolores Lara, Gynecologist, Principal investigator, Physician specializing in obstetrics and gynecology.Rafaela Dios Palomares, Engineer, Study chair, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126397
- Sponsor's protocol ID
- 230485
- Status last verified
- Jul 2014
- First submitted
- 28 Jan 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT02126397
- Acronym / sponsor ID
- 230485
- Conditions
- Endometrial Polyps
- Keywords
- endometrial polyp, resection of endometrial polyps, hysteroscopy, bipolar electrode Versapoint, Laser Diode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Isabel Bejerano BlázquezUniversity, hospital or other
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba, Universidad Nacional de Córdoba
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Apr 2014 (estimated)
- 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.
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. In recent years we have used the bipolar energy for resection of polyps by hysteroscopy, becoming a routine clinical practice and universally accepted.
Resection of endometrial polyps laser energy has recently begun to be used with satisfactory results, so studies are needed to analyze these results and compare it with the usual techniques .
This time in advance of medicine, it is appropriate to introduce minimally invasive procedures , allowing resection of endometrial polyps on an outpatient basis without anesthesia and acceptable to most patients.
These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .
Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
Detailed description
Main objective: To assess the tolerability of diode laser in the treatment of endometrial polyps using a visual analogue pain scale.
Secondary objectives:
- Determine if complete resection of polyps is achieved with both methods.
- Compare the time spent on the removal of the polyp in each of the hysteroscopic methods.
- To evaluate the safety of the laser diode with respect to the bipolar electrode (vagal syndrome, uterine perforation, infection, bleeding).
- Assess the recurrence of polyps after 3 months of resection (via hysteroscopy).
- Compare the degree of patient satisfaction with the different methods.
Design: randomized single blind clinical trial corresponds to an experimental analytical study. The patients randomly into 2 groups will include: Group A bipolar electrode treatment Versapoint and Group B diode laser treatment. Randomization was performed using a random table with 2 groups, generated in Microsoft Office Excel. The sample size needed to detect a difference in visual analog pain scale of a point with respect to the laser diode bipolar electrode is calculated; assuming a standard deviation of 1.75, a sample size of 49 patients in each group (98 would be needed in total), to a level of significance of 5% (0.05 α) with a power of 0.80 (beta 0.20). Assuming a loss of individuals from 5 to 10%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyps resection with Laser Diode | Active comparator | Procedure: polyps resection with Laser Diodeapplication of the laser diode by hysteroscopy to remove the endometrial polyp |
| polyps resection with bipolar electrode | Active comparator | Procedure: polyps resection with bipolar electrodeapplication of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients previously diagnosed of endometrial polyps that can be resected. The diagnosis will be made hysteroscopically. The patient must be informed about the study, and sign the informed consent.
Key exclusion criteria (1 listed)
- the usual exclusion criteria for surgical techniques, pregnant patients, patiens under 18 patients who did not sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyps resection with Laser Dioderesection of endometrial polyps by hysteroscopy without anesthesia | Procedure or surgery | polyps resection with Laser Diode |
| polyps resection with bipolar electrode | Procedure or surgery | polyps resection with bipolar electrode |
Primary outcome
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale
Time frame: we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
3 secondary outcomes
Determine if complete resection of polyps is achieved with both methods.
Time frame: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Compare the time spent on the removal of the polyp.
Time frame: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
To evaluate the safety of both methods
Time frame: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
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 10 Jul 2014.
- Reina Sofia University Hospital in Cordoba, SpainLink provided by the sponsor.
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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.
José Eduardo Arjona Berral, Gynecologist study director
Head of the Department of Obstetrics and Gynecology at the University Hospital Reina Sofia
Maria Dolores Lara, Gynecologist principal investigator
Physician specializing in obstetrics and gynecology.
Rafaela Dios Palomares, Engineer study chair
Universidad de Córdoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyps resection with Laser Diode and polyps resection with bipolar electrode in people with Endometrial Polyps, run by Isabel Bejerano Blázquez at 2 sites in Spain.
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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale (time frame: we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2014.