Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures

Completed

• Conditions: Hysteroscopic Surgery

• Registration Number: NCT02101827
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

Detailed Description

In order to minimize the amount of distending media infused during hysteroscopic procedures, investigators used manual syringe method for delivering of distending media during hysteroscopic procedures from June 2010 to November 2013 in our institute. The aim of this study was to evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

The medical records of all women who received hysteroscopic procedures by manual fluid-infusion method or convention pump fluid infusion method between June 2010 and November 2013 will be reviewed. In order to reveal the superiority/inferiority of clinical outcome of women receiving manual fluid infusion method, perioperative outcomes will be compared.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-30
• Study First Posted: 2014-04-02
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-04
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
• Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics & Gynecology in Far Eastern Memorial Hospital.

Exclusion Criteria

• Female patients of less than twenty years-old.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of manual fluid-distension methods for hysteroscopic procedures	1 week	The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures.

Secondary Outcome Measures

Name	Time	Method
Feasibility of manual fluid-infusion methods for hysteroscopic procedures	1 week	The perioperative data, including operation time, estimated blood loss, completion operation rate of hysteroscopic procedure by using manual fluid-infusion methods

Trial Locations

Locations (1)

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