Complication of Surgical ProcedureNCT02012010
Comparison of Infusion Methods for Hysteroscopic Procedures
A study testing Manual syringe infusion method and Pump infusion method in people with Complication of Surgical Procedure, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- Manual syringe infusion method and Pump infusion method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Dec 2013to 30 Jul 2017
- 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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
Who cannot join
- Female patients of less than twenty years-old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.
This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.
Read the detailed description
Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality related to infusion distension medium. We had used a manual syringe infusion method to infuse fluid for distending the uterine cavity in our institute without significant morbidity, and it seems that this method need less amount of distension medium, and possible result in less possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional infusion pump method to clarify if the manual syringe infusion method really needs less amount of distension medium during hysteroscopy.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Manual syringe infusion method, Pump infusion method
- Keywords
- hysteroscopy, water intoxication, hyponatremia
- Medical subject headings
- Water Intoxication, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual syringe infusion methodProcedure or surgery
Infuse the distension medium of hysteroscopy by manual syringe infusion method
Pump infusion methodProcedure or surgery
Infuse the distension medium of hysteroscopy by pump infusion method
| Study group | Role | What they receive |
|---|---|---|
| Manual syringe infusion method | Experimental | Infuse the distension medium of hysteroscopy by manual syringe infusion method Receives: Procedure: Manual syringe infusion method |
| Pump infusion method | Active comparator | Infuse the distension medium of hysteroscopy by pump infusion method Receives: Procedure: Pump infusion method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the amount of distension medium used
The amount of distension medium used between the manual syringe infusion method and the conventional infusion pump method of hysteroscopic surgery
Measured: 1 day
Secondary outcomes (1)
The difference of serum sodium and pain score, operation time
The difference of serum sodium and pain score, operation time between these two distension medium infusion methods of hysteroscopic surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study start6 Dec 2013
- Primary completion30 Jun 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
- Investigators
- Sheng-Mou Hsiao, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012010
- Sponsor's protocol ID
- 102124-F
- Status last verified
- Aug 2017
- First submitted
- 6 Dec 2013
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02012010
- Acronym / sponsor ID
- 102124-F
- Conditions
- Complication of Surgical Procedure
- Keywords
- hysteroscopy, water intoxication, hyponatremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 6 Dec 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 16 Dec 2013 (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.
This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.
Detailed description
Hysteroscopy is frequently used for diagnosing abnormal uterine bleeding, endometrial polyp or submucous myoma. However, hysteroscopic procedure can cause morbidity and even mortality related to infusion distension medium. We had used a manual syringe infusion method to infuse fluid for distending the uterine cavity in our institute without significant morbidity, and it seems that this method need less amount of distension medium, and possible result in less possibility of hyponatremia. Therefore, the aim of this study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional infusion pump method to clarify if the manual syringe infusion method really needs less amount of distension medium during hysteroscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual syringe infusion method | Experimental | Procedure: Manual syringe infusion methodInfuse the distension medium of hysteroscopy by manual syringe infusion method |
| Pump infusion method | Active comparator | Procedure: Pump infusion methodInfuse the distension medium of hysteroscopy by pump infusion method |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
Key exclusion criteria (1 listed)
- Female patients of less than twenty years-old.
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 |
|---|---|---|
| Manual syringe infusion methodInfuse the distension medium of hysteroscopy by manual syringe infusion method | Procedure or surgery | Manual syringe infusion method |
| Pump infusion methodInfuse the distension medium of hysteroscopy by pump infusion method | Procedure or surgery | Pump infusion method |
Primary outcome
The difference in the amount of distension medium used
Time frame: 1 day
The amount of distension medium used between the manual syringe infusion method and the conventional infusion pump method of hysteroscopic surgery
1 secondary outcome
The difference of serum sodium and pain score, operation time
Time frame: 1 day
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 14 Aug 2017.
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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.
Sheng-Mou Hsiao, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual syringe infusion method and Pump infusion method in people with Complication of Surgical Procedure, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 14 Aug 2017. 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 Taiwan. 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?
The difference in the amount of distension medium used (time frame: 1 day). 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 14 Aug 2017.