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Procedure
Warm and humidified CO2 pneumoperitoneum for Pneumoperitoneum
N/A
Waitlist Available
Led By Richard Whelan, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing elective laparoscopic colorectal resection (LCR) for all indications (cancer, diverticular disease, benign neoplasm, inflammatory bowel disease, etc)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days
Awards & highlights
Study Summary
This trial will test whether heating and humidifying CO2 used in laparoscopic surgery will reduce postoperative pain and inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of pain medications taken postoperatively
Timing of pain medications taken postoperatively
Secondary outcome measures
Analgesia requirements in the post anesthesia care unit
Duration of Surgery
Incision length
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Warm and humidified CO2 pneumoperitoneumExperimental Treatment1 Intervention
The humidification and warming device to be used is the Insuflow Synergy Port (Lexion Company, FDA approved) which is a specialized 5 mm port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source.
Group II: Cold and dry CO2 pneumoperitoneumPlacebo Group1 Intervention
Pneumoperitoneum is created by insufflation of standard cold (19-21°C) and nonhumidified (0%) CO2 directly from a standard CO2 tank or wall source.
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Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,933 Total Patients Enrolled
Richard Whelan, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being enrolled in this research endeavor?
"This study, which was initially posted on January 1st 2023 but last updated on the 18th of January in 2022, is not actively recruiting patients. Fortunately, 9 other trials are still open for participants."
Answered by AI
Is there an opportunity for me to participate in this clinical experiment?
"This medical trial is currently seeking 120 individuals with pneumoperitoneum aged 18-85 for a laparoscopic colorectal resection (LCR). Potential participants must have been scheduled to receive the procedure due to cancer, diverticular disease, benign neoplasm, or inflammatory bowel disease."
Answered by AI
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