Comparison of Infusion Methods for Hysteroscopic Procedures

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012010
• Other study ID #: 102124-F
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: August 10, 2017
• Start date: December 6, 2013
• Est. completion date: July 30, 2017

Study information

• Verified date: August 2017
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Surgical Procedure

Intervention

Procedure:
• Manual syringe infusion method
Infuse the distension medium of hysteroscopy by manual syringe infusion method
• Pump infusion method
Infuse the distension medium of hysteroscopy by pump infusion method

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Banqiao	New Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	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	1 day