NCT06195826

Brief Summary

To compare the perioperative outcome between the gravity versus pump infusion groups in women who received hysteroscopic myomectomy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 5, 2023

Last Update Submit

January 5, 2024

Conditions

Hysteroscopic Myomectomy

Outcome Measures

Primary Outcomes (1)

  • Infusion volume of distension medium

    Infusion volume (mL) of distension medium in the uterine cavity between the gravity and pump infusion methods for hysterosopic myomectomy

    1 week

Secondary Outcomes (3)

  • Intraoperative blood loss

    1 week

  • Postoperative pain

    1 week

  • Surgical time

    1 week

Study Arms (2)

gravity infusion

women who received hysteroscopic myomectomy with gravity infusion method

Procedure: Gravity infusion

pump infusion

women who received hysteroscopic myomectomy with pump infusion method

Procedure: Pump infusion

Interventions

Gravity infusionPROCEDURE

hysteroscopic myomectomy with the gravity infusion method

gravity infusion
Pump infusionPROCEDURE

hysteroscopic myomectomy with the pump infusion method

pump infusion

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with uterine myoma
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received hysteroscopic myomectomy

You may qualify if:

  • \>20 years old women
  • women who received hysteroscopic myomectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital

Banqiao District, New Taipei, 22050, Taiwan

RECRUITING

MeSH Terms

Interventions

Infusion Pumps

Intervention Hierarchy (Ancestors)

Equipment and SuppliesArtificial OrgansSurgical Equipment

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Obstetrics & Gynecology

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 8, 2024

Study Start

November 21, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

TW(1)