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

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

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Key information

Conditions

Hysteroscopic Surgery

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Safety of manual fluid-distension methods for hysteroscopic procedures

Time frame: 1 week

The complications (such as hyponatremia, abdominal pain) related to manual fluid-distension methods for hysteroscopic procedures.

Secondary outcomes

Feasibility of manual fluid-infusion methods for hysteroscopic procedures

Time frame: 1 week

The perioperative data, including operation time, estimated blood loss, completion operation rate of hysteroscopic procedure by using manual fluid-infusion methods

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 2, 2014
Registry last updated: Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed