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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
No Placebo-Only Group

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.
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.
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 below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurement in centimeters the patients incision lengths at the closing of the surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement in centimeters the patients incision lengths at the closing of the surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain as assessed by the visual analog scale (VAS)
Secondary study objectives
Analgesic requirements in the Post Anesthesia Care Unit (PACU)
Duration of surgery
Incision length
+7 more

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
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
946 Previous Clinical Trials
344,235 Total Patients Enrolled
Erik Wilson, MD, FACSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Minimally Invasive Bariatric (Gastric Bypass) Surgery Clinical Trial Eligibility Overview. Trial Name: NCT05838300 — N/A
Post-Gastric Bypass Surgery Research Study Groups: Warm humidified CO2, Dry CO2
Post-Gastric Bypass Surgery Clinical Trial 2023: Minimally Invasive Bariatric (Gastric Bypass) Surgery Highlights & Side Effects. Trial Name: NCT05838300 — N/A
Minimally Invasive Bariatric (Gastric Bypass) Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838300 — N/A
~22 spots leftby Nov 2025
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