Comparison of Infusion Methods for Hysteroscopic Procedures

Far Eastern Memorial Hospital

Status: Completed

Conditions: Complication of Surgical Procedure

Treatments: Procedure: Pump infusion method; Procedure: Manual syringe infusion method

Study type: Interventional

Funder types: Other

Identifiers

NCT02012010

102124-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Manual syringe infusion method

Experimental group

Description:

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Treatment:

Procedure: Manual syringe infusion method

Pump infusion method

Active Comparator group

Description:

Infuse the distension medium of hysteroscopy by pump infusion method

Treatment:

Procedure: Pump infusion method