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Solution Temperature for Hysteroscopic Surgery (STOFD Trial)

N/A
Recruiting
Led By Aya Mohr-Sasson
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- All women undergoing gynecologic hysteroscopic surgery.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after the procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the role of temperature in hysteroscopic surgery, used to treat gynecological diseases. Complication rate is estimated at 0.22%, with major complication being fluid overload.

Who is the study for?
This trial is for women undergoing hysteroscopic surgery, a procedure used to treat various gynecological issues. It's open to all women who are scheduled for this type of surgery.
What is being tested?
The study is testing the effects of irrigation fluid temperature on fluid absorption during hysteroscopy. Participants will receive saline warmed to either 37 degrees Celsius or 24 degrees Celsius to see if temperature affects the risk of fluid overload.
What are the potential side effects?
There may not be direct side effects from the different temperatures of saline, but risks associated with hysteroscopy include uterine perforation, heavy bleeding, and complications from fluid overload.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from recruitment until follow up visit 2 weeks post operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and from recruitment until follow up visit 2 weeks post operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Median time to reach deficit of 100 cc
Secondary study objectives
Total fluid deficit
Visual analog scale (VAS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Warmed salineExperimental Treatment1 Intervention
0.9% Saline will be warmed to 37 degrees Celsius
Group II: Room temperature salineExperimental Treatment1 Intervention
0.9% Saline will be warmed to 24 degrees Celsius

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,762 Total Patients Enrolled
3 Trials studying Surgery
189 Patients Enrolled for Surgery
Aya Mohr-SassonPrincipal InvestigatorThe University of Texas Health Science Center, Houston, TX
2 Previous Clinical Trials
175 Total Patients Enrolled
2 Trials studying Surgery
175 Patients Enrolled for Surgery
~37 spots leftby Dec 2025
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