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CompletedNCT02101827Updated Jul 7, 2015

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

An observational study in Hysteroscopic Surgery, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-07-07.

Sponsored by Far Eastern Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
20 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hysteroscopic Surgery
03

In context

Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose

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

Exclusion Criteria:

  • Female patients of less than twenty years-old.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hysteroscopic surgery

    Women who received hysteroscopic surgeries or examinations

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

Secondary outcomes

  1. 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

    Time frame: 1 week

07

Study locations

1 site
  • Far Eastern Memorial Hospital
    Banqiao, New Taipei 22050, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02101827
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sheng-Mou Hsiao (Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital) — Principal investigator
First posted
Apr 2, 2014
Start date
Mar 2014
Primary completion
May 2015
Completion
May 2015
Last update
Jul 7, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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