Comparison of Infusion Methods for Hysteroscopic Procedures

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02012010

Enrollment

100

Registered

2013-12-16

Start date

2013-12-06

Completion date

2017-07-30

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Surgical Procedure

Keywords

hysteroscopy, water intoxication, hyponatremia

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.

Interventions

PROCEDUREManual syringe infusion method

Infuse the distension medium of hysteroscopy by manual syringe infusion method

PROCEDUREPump infusion method

Infuse the distension medium of hysteroscopy by pump infusion method

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026