Warm Humidified CO2 Insufflation for Gastric Bypass Surgery

Overseen By Angielyn Rivera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Narcotics, Steroids

Disqualifiers: Narcotics addiction, Paraplegic, Quadriplegic, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether warm and humidified carbon dioxide (CO2) during gastric bypass surgery can reduce postoperative pain. The focus is on individuals undergoing this weight-loss surgery, aiming to determine if this method decreases the need for pain medication afterward. Participants will be divided into two groups: one receiving warm and humidified CO2, and the other receiving dry CO2. Candidates planning elective gastric bypass or hernia surgery who are not on daily pain medication may be suitable for participation. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking daily pain medications (narcotics) or steroids.

What prior data suggests that warm humidified CO2 insufflation is safe for gastric bypass surgery?

Research has shown that using warm, moist CO2 during keyhole gastric bypass surgery is generally safe. Studies have found that this method can reduce post-surgery pain and may help speed up recovery. Other research indicates it can lower the risk of hypothermia, a condition where body temperature drops too low, during surgery. Overall, evidence suggests that warm, moist CO2 is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Warm humidified CO2 insufflation is unique because it offers a new approach for improving gastric bypass surgery. Unlike the standard use of dry CO2 during minimally invasive surgeries, this method uses CO2 that is both warm and humidified. Researchers are excited because this could potentially reduce discomfort and speed up recovery by minimizing the cooling and drying effects that dry CO2 can have on tissues. This innovative technique might lead to a more comfortable postoperative experience for patients undergoing bariatric surgery.

What evidence suggests that this trial's treatments could be effective for reducing post-operative pain in gastric bypass surgery?

This trial will compare warm humidified CO2 with dry CO2 during minimally invasive bariatric (gastric bypass) surgery. Research has shown that using warm, moist carbon dioxide (CO2) during keyhole gastric bypass surgery can be beneficial. Specifically, studies have found that this approach helps maintain a steady body temperature during the operation. In one study with 50 patients, those who received warm, moist CO2 reported less shoulder pain afterward. Other research suggests this method might reduce overall pain and improve comfort after surgery. These findings indicate that warm, moist CO2 could ease recovery and enhance comfort following gastric bypass surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Erik B Wilson, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic bariatric surgery using either warm humidified CO2 or dry CO2

1 day

1 visit (in-person)

Postoperative Care

Participants are monitored in the Post Anesthesia Care Unit (PACU) for analgesic requirements and temperature

Several hours

1 visit (in-person)

Follow-up

Participants are monitored for pain and analgesia requirements post-surgery

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Dry CO2
• Minimally Invasive Bariatric (Gastric Bypass) Surgery
• Warm humidified CO2

Trial Overview

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.

How Is the Trial Designed?

Group I: Warm humidified CO2 Experimental Treatment 1 Intervention

Group II: Dry CO2 Active Control 1 Intervention

Minimally Invasive Bariatric (Gastric Bypass) Surgery is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Laparoscopic Gastric Bypass Surgery for:

• Obesity
• Type 2 Diabetes Mellitus
• Gastroesophageal Reflux Disease

Approved in United States as Laparoscopic Gastric Bypass Surgery for:

• Obesity
• Type 2 Diabetes Mellitus
• Gastroesophageal Reflux Disease
• Sleep Apnea

Approved in Canada as Laparoscopic Gastric Bypass Surgery for:

• Obesity
• Type 2 Diabetes Mellitus
• Gastroesophageal Reflux Disease

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 50 patients undergoing laparoscopic gastric bypass, heated-humidified carbon dioxide insufflation led to significantly less shoulder pain at 18 hours post-surgery compared to cold-dry insufflation.

However, there were no significant differences in abdominal pain, overall narcotic use, or length of hospital stay between the two groups, indicating that while heated-humidified gas may help with shoulder pain, it does not provide major benefits in other areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective randomized trial of heated humidified versus cold dry carbon dioxide insufflation during laparoscopic gastric bypass. Champion, JK., Williams, M.[2013]

The Mini Gastric Bypass (MGB) is a safe and effective bariatric surgery option, but it can lead to complications such as perforated gastric ulcers, as seen in a case study of a 41-year-old female patient.

Laparoscopic treatment for perforated gastric ulcers, including closure of the leak and thorough abdominal irrigation, has shown good outcomes, allowing the patient to be discharged just four days post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perforated gastric ulcer post mini gastric bypass treated by laparoscopy: A case report. Garcia, DPC., Dos Reis, CF., de Figueiredo, LO., et al.[2022]

In a study of 30 patients undergoing laparoscopic Roux-en-Y gastric bypass, using warmed and humidified CO2 for insufflation did not significantly reduce postoperative pain or narcotic usage compared to standard dry CO2.

However, the warmed and humidified CO2 group experienced shorter operating room times (76 vs 101 minutes) and reduced hospital stays (3.2 vs 4.0 days), indicating potential logistical benefits without impacting pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of humidified, warmed carbon dioxide insufflation during laparoscopic bariatric surgery: a randomized clinical trial. Savel, RH., Balasubramanya, S., Lasheen, S., et al.[2017]

Gastric bypass surgery for very obese patients, while technically challenging, can be performed safely with careful attention to detail before, during, and after the procedure.

The surgery is effective in achieving weight loss and is associated with manageable complications, making it a viable option for treating severe obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastric bypass. Hornberger, HR.[2019]

Minimally invasive bariatric procedures increasingly use high flow CO2 insufflators, which can achieve stable intra-abdominal pressure more quickly and effectively than traditional insufflators, enhancing the surgical field.

While increased intra-abdominal pressure can affect venous flow and other physiological parameters, clinical complications are rare, and minimizing operation duration can help reduce patient exposure to potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Daskalakis, M., Scheffel, O., Weiner, RA.[2021]

Heating and humidifying the insufflation gas during laparoscopic surgery effectively prevents intraoperative hypothermia, as shown in a rat model study where core temperatures remained stable in the warm, humidified CO2 group.

Despite the benefits of heated and humidified gas, changes to the peritoneal surface were observed in all insufflation groups, indicating that some level of tissue impact occurs regardless of the gas conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of temperature and humidity of carbon dioxide pneumoperitoneum on body temperature and peritoneal morphology. Hazebroek, EJ., Schreve, MA., Visser, P., et al.[2019]

Warming and humidifying carbon dioxide (CO2) used in laparoscopic surgery showed only a small beneficial effect on immediate postoperative pain and hypothermia compared to standard CO2 insufflation, based on a review of 17 relevant clinical studies.

No significant differences were found in other outcomes such as later postoperative pain, analgesic consumption, recovery times, or procedure duration, indicating that the advantages of using warmed and humidified CO2 may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Warmed and humidified carbon dioxide for abdominal laparoscopic surgery: meta-analysis of the current literature. Balayssac, D., Pereira, B., Bazin, JE., et al.[2018]

Laparoscopic gastric bypass is a safe and effective surgical option for treating morbid obesity, showing similar outcomes to traditional open gastric bypass but with fewer complications.

Patients undergoing laparoscopic gastric bypass experience shorter hospital stays, less pain, and quicker recovery times, making it a preferable choice for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic gastric bypass for refractory morbid obesity. Simpfendorfer, CH., Szomstein, S., Rosenthal, R.[2005]

Using helium instead of carbon dioxide for insufflation during laparoscopic gastric bypass surgery resulted in significantly lower levels of carbon dioxide (pCO2) and higher pH levels in a study involving 5 Yorkshire swine.

Helium insufflation allowed for a quicker normalization of pCO2 levels after surgery, suggesting it may reduce the risk of hypercarbia and acidosis compared to traditional CO2 insufflation, indicating potential benefits for morbidly obese patients undergoing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helium pneumoperitoneum ameliorates hypercarbia and acidosis associated with carbon dioxide insufflation during laparoscopic gastric bypass in pigs. Brackman, MR., Finelli, FC., Light, T., et al.[2013]

Warming and humidifying insufflated carbon dioxide (CO2) during laparoscopic surgery can prevent a minor heat loss of 3220 calories, which translates to a temperature decrease of only 0.06°C in a 70 kg patient.

The study suggests that the thermal benefit of this practice is minimal compared to other more effective and cost-efficient methods for preventing perioperative hypothermia, indicating that the decision to use this approach should consider its overall risks, benefits, and costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment by calorimetric calculations of the potential thermal benefit of warming and humidification of insufflated carbon dioxide. Roth, JV., Sea, S.[2014]

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