NCT02012010

Brief Summary

This study is to perform a randomized controlled trial of comparing the manual syringe infusion method with the conventional pump infusion method to clarify if the manual syringe infusion method really needs less amount of distension medium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

December 6, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

December 6, 2013

Last Update Submit

August 10, 2017

Conditions

Complication of Surgical Procedure

Keywords

hysteroscopy, water intoxication, hyponatremia

Outcome Measures

Primary Outcomes (1)

  • The difference in the amount of distension medium used

    The amount of distension medium used between the manual syringe infusion method and the conventional infusion pump method of hysteroscopic surgery

    1 day

Secondary Outcomes (1)

  • The difference of serum sodium and pain score, operation time

    1 day

Study Arms (2)

Manual syringe infusion method

EXPERIMENTAL

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Procedure: Manual syringe infusion method

Pump infusion method

ACTIVE COMPARATOR

Infuse the distension medium of hysteroscopy by pump infusion method

Procedure: Pump infusion method

Interventions

Manual syringe infusion methodPROCEDURE

Infuse the distension medium of hysteroscopy by manual syringe infusion method

Manual syringe infusion method
Pump infusion methodPROCEDURE

Infuse the distension medium of hysteroscopy by pump infusion method

Pump infusion method

Eligibility Criteria

Age20 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.

You may not qualify if:

  • Female patients of less than twenty years-old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Water IntoxicationHyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPoisoningChemically-Induced Disorders

Study Officials

  • Sheng-Mou Hsiao, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 16, 2013

Study Start

December 6, 2013

Primary Completion

June 30, 2017

Study Completion

July 30, 2017

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

TW(1)