Comparison of Infusion Methods for Hysteroscopic Procedures

NCT ID: NCT02012010

Last Updated: 2017-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-06

Study Completion Date

2017-07-30

Brief Summary

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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

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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

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Complication of Surgical Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Manual syringe infusion method

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Group Type EXPERIMENTAL

Manual syringe infusion method

Intervention Type PROCEDURE

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Pump infusion method

Infuse the distension medium of hysteroscopy by pump infusion method

Group Type ACTIVE_COMPARATOR

Pump infusion method

Intervention Type PROCEDURE

Infuse the distension medium of hysteroscopy by pump infusion method

Interventions

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Manual syringe infusion method

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Intervention Type PROCEDURE

Pump infusion method

Infuse the distension medium of hysteroscopy by pump infusion method

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.

Exclusion Criteria

* Female patients of less than twenty years-old.
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheng-Mou Hsiao, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Locations

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Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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102124-F

Identifier Type: -

Identifier Source: org_study_id

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