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NCT Number: NCT02012010

Comparison of Infusion Methods for Hysteroscopic Procedures

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.

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Key information

Conditions

Complication of Surgical Procedure Chemically-Induced Disorders Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Poisoning Water Intoxication Water-Electrolyte Imbalance

Age range

20 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual syringe infusion method

Procedure

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Pump infusion method

Procedure

Infuse the distension medium of hysteroscopy by pump infusion method

Primary outcomes

  1. 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

Secondary outcomes

  1. The difference of serum sodium and pain score, operation time

    Time frame: 1 day

    The difference of serum sodium and pain score, operation time between these two distension medium infusion methods of hysteroscopic surgery

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Comparison of Manual Syringe Infusion Method and Conventional Pump Infusion Method for Hysteroscopic Procedures: a Randomized Controlled Trial.

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2013
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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