Warm and Humidified vs Cold and Dry Carbon Dioxide (CO2) 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

Summary

This trial will test whether heating and humidifying CO2 used in laparoscopic surgery will reduce postoperative pain and inflammation.

Eligible Conditions

Pneumoperitoneum
Free air in the abdominal cavity

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of pain medications taken postoperatively

Timing of pain medications taken postoperatively

Secondary study objectives

Number of pain medications taken after discharge

Postoperative pain levels

Volume of CO2 consumed during surgery

Trial 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.

0 / 1Eligibility criteria met