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

NCT ID: NCT02101827

Last Updated: 2015-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hysteroscopic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hysteroscopic surgery

Women who received hysteroscopic surgeries or examinations

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Mou Hsiao

Chief, Department of Obstetrics & Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Far Eastern Memorial Hospital

Banqiao District, New Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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103006-E

Identifier Type: -

Identifier Source: org_study_id

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