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Warm Humidified CO2 Insufflation for Gastric Bypass Surgery
N/A
Recruiting
Led By Erik Wilson, MD, FACS
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
elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the admission to discharge of the patient in hours
Awards & highlights
Study Summary
This trial studies how warm, humidified CO2 can reduce post-op pain after laparoscopic bariatric surgery.
Who is the study for?
This trial is for patients scheduled for elective bariatric surgery, including primary or revision procedures and hiatal hernia repairs. It's not specified who can't join the trial.Check my eligibility
What is being tested?
The study compares two methods of insufflation (pumping gas to expand the abdomen) during laparoscopic bariatric surgery: one uses dry CO2, and the other uses warm humidified CO2. The goal is to see if warm humidified CO2 reduces post-operative pain and need for painkillers.See study design
What are the potential side effects?
Potential side effects may include discomfort from the insufflation gases, variations in body temperature due to warming of CO2, abdominal bloating, and possible changes in respiratory function during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of the surgery to the end of the surgery in minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of the surgery to the end of the surgery in minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain as assessed by the visual analog scale (VAS)
Secondary outcome measures
Analgesic requirements in the Post Anesthesia Care Unit (PACU)
Duration of surgery
Incision length
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Warm humidified CO2Experimental Treatment1 Intervention
Group II: Dry CO2Active Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,906 Total Patients Enrolled
Erik Wilson, MD, FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Warm humidified CO2
- Group 2: Dry CO2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment restricted to adults or open to all ages?
"This medical study is inviting applicants between the ages of 18 to 65."
Answered by AI
Is enrollment in this clinical trial still open?
"Unfortunately, this trial is not actively recruiting individuals at the moment. The study was first published on May 15th 2023 and last updated on April 20th 2023. Nonetheless, there are still 31 other clinical trials seeking willing participants for their research studies."
Answered by AI
Is there an opportunity to be involved in this experiment?
"To be accepted into this trial, individuals must have previously had gastric bypass surgery and fall within the ages of 18 to 65. There is space for 54 participants in total."
Answered by AI
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