Comparison of Infusion Methods for Hysteroscopic Procedures

Study Overview
=================
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.

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

Conditions
-----------------
Complication of Surgical Procedure

Intervention / Treatment
-----------------
* Procedure: Manual syringe infusion method
* Procedure: Pump infusion method


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual syringe infusion method<br>Infuse the distension medium of hysteroscopy by manual syringe infusion method | Procedure: Manual syringe infusion method<br>* Infuse the distension medium of hysteroscopy by manual syringe infusion method<br>|
| Active Comparator: Pump infusion method<br>Infuse the distension medium of hysteroscopy by pump infusion method | Procedure: Pump infusion method<br>* Infuse the distension medium of hysteroscopy by pump infusion method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysteroscopy, water intoxication, hyponatremia