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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.

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 data supports the effectiveness of the treatment Warm Humidified CO2 Insufflation for Gastric Bypass Surgery?

Research suggests that using warm humidified carbon dioxide (CO2) during laparoscopic gastric bypass surgery can reduce postoperative pain and the need for pain medication, as well as shorten recovery time compared to using cold dry CO2. This is because the warm humidified CO2 helps prevent hypothermia (abnormally low body temperature) and drying out of cells in the abdomen. ^{1 2 3 4 5}

Is warm humidified CO2 insufflation safe for use in gastric bypass surgery?

Research indicates that using warm humidified CO2 during laparoscopic gastric bypass surgery is generally safe and may reduce postoperative pain and recovery time compared to cold dry CO2. However, it may increase the cost of the procedure. ^{1 3 6 7 8}

What makes warm humidified CO2 insufflation unique in gastric bypass surgery?

Warm humidified CO2 insufflation during gastric bypass surgery is unique because it uses heated and humidified gas instead of cold, dry gas, which can reduce postoperative pain, hypothermia, and recovery time compared to traditional methods. ^{1 2 4 9 10}

Research Team

Erik B Wilson, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of humidified, warmed carbon dioxide insufflation during laparoscopic bariatric surgery: a randomized clinical trial. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Helium pneumoperitoneum ameliorates hypercarbia and acidosis associated with carbon dioxide insufflation during laparoscopic gastric bypass in pigs. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Laparoscopic gastric bypass for refractory morbid obesity. [2005]

7. England pubmed.ncbi.nlm.nih.gov

Perforated gastric ulcer post mini gastric bypass treated by laparoscopy: A case report. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Gastric bypass. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of temperature and humidity of carbon dioxide pneumoperitoneum on body temperature and peritoneal morphology. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Warmed and humidified carbon dioxide for abdominal laparoscopic surgery: meta-analysis of the current literature. [2018]