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Surgical Field Irrigation Techniques for Clearer Endoscopic Views

Phase 1

Recruiting

Led By Carl Snyderman, MD

Research Sponsored by Carl Snyderman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient with a primary pituitary adenoma, macro or micro adenoma.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 min

Awards & highlights

Study Summary

This trial will compare two types of fluids used to rinse the area during surgery to see which one provides a better view for the surgeon.

Who is the study for?

This trial is for patients with a primary pituitary adenoma, either macro or micro. It's not suitable for individuals under 18, those undergoing revision surgery, pregnant women, or anyone who isn't a candidate for surgery due to medical reasons.Check my eligibility

What is being tested?

The study aims to compare the effectiveness of two solutions—Normal Saline and Lactated Ringer's—in maintaining clear visibility during endoscopic surgery for pituitary adenomas.See study design

What are the potential side effects?

While the trial focuses on surgical field clarity rather than side effects, both irrigation solutions are generally well-tolerated with minimal risk of adverse reactions when used appropriately in surgery.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have a pituitary adenoma, either large or small.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 min

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 min

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 min for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Boezaart scale rating video clips

Time

Secondary outcome measures

Estimated Blood Loss (EBL)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lactated Ringer's IrrigationExperimental Treatment1 Intervention

This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the lactated reinger group using a random number generator.

Group II: Normal SalineActive Control1 Intervention

This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the normal saline group using a random number generator.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carl SnydermanLead Sponsor

1 Previous Clinical Trials

Carl Snyderman, MDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

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

Are there any vacancies remaining in this experiment for research subjects?

"According to the details accessible on clinicaltrials.gov, this medical trial is actively looking for potential participants; it was initially posted on February 9th 2022 and its information was last revised on March 4th 2022."

Answered by AI

How many subjects are involved in the current clinical trial?

"Indeed, clinicaltrials.gov specifies that this trial is in the process of recruiting patients; it was initially posted on February 9th 2022 and most recently updated on March 4th 2022. The study aims to enrol 30 participants at one specified medical site."

Answered by AI

What medical conditions is Lactated Ringer's Irrigation traditionally used to treat?

"Lactated Ringer's Irrigation is useful in replenishing electrolyte stores and can also be employed to address parenteral nutrition, regional citrate anticoagulation (RCA), and skin afflictions."

Answered by AI

Have past experiments utilized Lactated Ringer's Irrigation?

"Currently, there are 108 active clinical trials related to Lactated Ringer's Irrigation. Of those studies, 27 have reached the Phase 3 stage of research. Calgary is home to most of these investigations while 400 sites across North America are running trial on this treatment."

Answered by AI

What implications does Lactated Ringer's Irrigation have for human health?

"The perceived safety of Lactated Ringer's Irrigation registered a 1 on our scale due to the limited clinical evidence available at this early stage in its development."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation

Carl Snyderman 2022. "Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161780.