Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy

Gravity Versus Pump Infusion of Distending Media for Hysteroscopic Myomectomy: A Retrospective Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Hysteroscopic Myomectomy
• Intervention / Treatment: Procedure: Gravity infusion; Procedure: Pump infusion

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei
    • Banqiao, New Taipei, Taiwan, 22050
      • Recruiting
      • Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
      • Contact: Sheng-Mou Hsiao, M.D.; Phone Number: 1818 +886-2-89667000; Email: smhsiao2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received hysteroscopic myomectomy

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
gravity infusion; women who received hysteroscopic myomectomy with gravity infusion method	Procedure: Gravity infusion; hysteroscopic myomectomy with the gravity infusion method
pump infusion; women who received hysteroscopic myomectomy with pump infusion method	Procedure: Pump infusion; hysteroscopic myomectomy with the pump infusion method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	Intraoperative blood loss (mL) between the gravity and pump infusion methods for hysterosopic myomectomy	1 week
Postoperative pain	Postoperative pain (visual analogue scale 0-10) in the recovery room between the gravity versus pump infusion methods for hysterosopic myomectomy.	1 week
Surgical time	Surgical time (minutes) between the gravity versus pump infusion methods for hysterosopic myomectomy	1 week

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 112180-E

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No