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

Hysteroscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101827
• Other study ID #: 103006-E
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: July 4, 2015
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hysteroscopic Surgery

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	Safety of manual fluid-distension methods for hysteroscopic procedures	The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures.	1 week	Yes
Secondary	Feasibility of manual fluid-infusion methods for hysteroscopic procedures	The perioperative data, including operation time, estimated blood loss, completion operation rate of hysteroscopic procedure by using manual fluid-infusion methods	1 week	Yes