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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02101827

Enrollment

200

Registered

2014-04-02

Start date

2014-03-31

Completion date

2015-05-31

Last updated

2015-07-07

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

Conditions

Hysteroscopic Surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

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. * 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Outcome results