Comparison of Infusion Methods for Hysteroscopic Procedures

Not Applicable

Completed

• Conditions: Complication of Surgical Procedure
• Interventions: Procedure: Pump infusion method; Procedure: Manual syringe infusion method

• Registration Number: NCT02012010
• Lead Sponsor: Far Eastern Memorial Hospital

Brief 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.

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 Timeline

• Study Start: 2013-12-06
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pump infusion method	Pump infusion method	Infuse the distension medium of hysteroscopy by pump infusion method
Manual syringe infusion method	Manual syringe infusion method	Infuse the distension medium of hysteroscopy by manual syringe infusion method

Primary Outcome Measures

Name	Time	Method
The difference in the amount of distension medium used	1 day	The amount of distension medium used between the manual syringe infusion method and the conventional infusion pump method of hysteroscopic surgery

Secondary Outcome Measures

Name	Time	Method
The difference of serum sodium and pain score, operation time	1 day	The difference of serum sodium and pain score, operation time between these two distension medium infusion methods of hysteroscopic surgery

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 Banqiao, New Taipei, Taiwan