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Warmed saline for 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

STOFD Trial 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.Check my eligibility

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.See study design

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.

STOFD Trial Eligibility Criteria

Inclusion Criteria

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

STOFD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from recruitment until follow up visit 2 weeks post operation

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median time to reach deficit of 100 cc

Secondary outcome measures

Total fluid deficit

Visual analog scale (VAS)

STOFD 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,870 Total Patients Enrolled

3 Trials studying Surgery

325 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there capacity for more participants in this experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is in the process of enlisting participants; it was initially posted on December 1st 2023 and updated lastly on that same date. The researchers need 90 individuals from a single site for their experiment."

Answered by AI

How many participants are taking part in this research endeavor?

"Affirmative. According to the resources on clinicaltrials.gov, this research project is actively recruiting participants since December 1st 2023 and has a goal of enrolling 90 patients at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Solution Temperature and Fluid Deficit During Hysteroscopy

Aya Mohr Sasson 2023. "Solution Temperature and Fluid Deficit During Hysteroscopy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05622097.