Low Pressure Pneumoperitoneum for Postoperative Ileus

Recruiting at 1 trial location

Overseen By Alberto Uribe, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Aminoglycosides, Magnesium

Disqualifiers: Inflammatory bowel disease, Intestinal ischemia, Intestinal adhesions, others

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

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using lower pressure during laparoscopic large bowel surgery aids bowel recovery and reduces postoperative ileus, a condition where the bowel doesn't function properly after surgery. Researchers aim to determine if different pressures and devices used during surgery, such as the pneumoperitoneum insufflation device, can lead to quicker hospital discharge and less bowel dysfunction. The trial will include five groups of patients undergoing surgery to test these various pressures and devices. Adults undergoing laparoscopic surgery to remove bowel tumors or polyps might be suitable for this study. As an unphased trial, this study offers patients the chance to contribute to innovative surgical techniques that could enhance recovery and improve surgical outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but if you are on drugs that could affect the study's focus on postoperative ileus, you might be excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that low-pressure pneumoperitoneum, a method to gently inflate the abdomen with gas during surgery, is generally safe and may offer benefits. One study found that patients with lower pressure settings experienced fewer cases of ileus, a temporary halt in bowel movements, compared to those with higher pressure. Specifically, only 10% of patients with low pressure experienced ileus, while 30% of those with high pressure did. They also regained bowel function faster, passing gas and having bowel movements sooner.

Regarding the AirSeal® system, which maintains stable pressure during surgery, studies indicate it is as safe as traditional methods and might even enhance the surgical experience. However, some reports of device issues exist, though these are rare.

Overall, both traditional and AirSeal® systems at lower pressures appear well-tolerated by patients. This suggests these methods are safe options for surgery, with the added benefit of potentially faster recovery times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different techniques in surgery might help reduce postoperative ileus, which is a common and uncomfortable delay in bowel function recovery after surgery. Unlike traditional methods that use high pneumoperitoneum pressure and moderate neuromuscular blockade, this trial examines the effects of both low and high pneumoperitoneum pressures combined with different blockade depths and devices like the AirSeal® system. The AirSeal® system, in particular, is noteworthy for its ability to maintain stable pressure and clear the surgical field, potentially leading to less stress on the body. By comparing these approaches, researchers hope to pinpoint which method is best for reducing postoperative discomfort and speeding up recovery.

What evidence suggests that this trial's treatments could be effective for postoperative ileus?

Research has shown that low-pressure pneumoperitoneum, the gas used to gently inflate the abdomen during surgery, can reduce pain and temporary bowel paralysis post-surgery. In this trial, some participants will undergo surgery with low-pressure pneumoperitoneum. Studies suggest that using low pressure may also decrease intestinal inflammation, aiding faster gut healing. The AirSeal system, another method tested in this trial to manage abdominal pressure during surgery, has improved outcomes such as shorter surgery times and better control of carbon dioxide levels. Both low-pressure pneumoperitoneum and the AirSeal system are studied in separate arms of this trial for their potential to enhance recovery and reduce complications after bowel surgeries. ^{1 2 5 6 7}

Who Is on the Research Team?

Fedias L Christofi, Ph.D., AGAF

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Adults over 18 needing laparoscopic surgery for large bowel issues like tumors or polyps can join. They must agree to participate and not have inflammatory bowel disease, past major abdominal surgeries (except appendectomies/hernia repairs), conditions affecting drug metabolism, significant other illnesses, certain pre-surgery imbalances, a history of intestinal adhesions, or allergies to specific drugs used in the study.

Inclusion Criteria

I am having a laparoscopic surgery to remove a tumor in the right side of my colon.

I am having surgery to remove growths or pouches in my lower colon.

Exclusion Criteria

Significant comorbid conditions as determined by the study personnel at the screening stage

I have a history of intestinal adhesions.

I have a history of inflammatory bowel disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic large bowel surgery with varying pneumoperitoneum pressures and neuromuscular blockade techniques

Surgery duration

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative ileus, gastrointestinal function recovery, and other clinical outcomes

Up to 30 days

Daily monitoring (in-hospital)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neuromuscular blockade
• Neuromuscular blockade reversal
• Pneumoperitoneum insufflation device
• Pneumoperitoneum Pressure

Trial Overview The trial is testing if using lower pressure inside the abdomen during surgery leads to quicker recovery from postoperative ileus (bowel paralysis) and gastrointestinal dysfunction. It compares high vs low pressures with different devices that control this pressure during laparoscopic bowel resections.

How Is the Trial Designed?

Group I: Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade Experimental Treatment 4 Interventions

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using low pneumoperitoneum pressure with AirSeal® TM system under deep neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Group II: Arm 3A: Conventional Pneumoperitoneum and Deep Blockade Experimental Treatment 4 Interventions

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using low pneumoperitoneum pressure with conventional insufflation under deep neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Group III: Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade Experimental Treatment 4 Interventions

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with AirSeal® trademark (TM) system under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Group IV: Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade Experimental Treatment 4 Interventions

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with conventional insufflation under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Group V: Arm 1: Standard of Care Active Control 1 Intervention

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with conventional insufflation under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with neostigmine. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05344417

Low Pressure Pneumoperitoneum and Postoperative Ileus ... Our study will focus on the effects of high or low intraperitoneal pressure as well as pressure variations on the course of postoperative ileus, time to ...

2. ctv.veeva.com ctv.veeva.com/study/low-pressure-pneumoperitoneum-and-postoperative-ileus

Low Pressure Pneumoperitoneum and Postoperative Ileus Our study will focus on the effects of high or low intraperitoneal pressure as well as pressure variations on the course of postoperative ileus, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4078359/

study protocol of a randomized controlled trial - PMC This is a single center randomized controlled trial comparing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair with AirSeal™ (group A) ...

4. conmed.com conmed.com/en/products/airseal-and-insufflation/airseal-data

AirSeal Clinical Study Appendix Reduction in Postoperative Ileus Rates Utilizing Lower Pressure Pneumoperitoneum in Robotic-assisted Radical Prostatectomy. Authors: M Rohloff, T Maatman, et ...

5. researchgate.net researchgate.net/publication/382943625_A_systematic_review_and_meta-analysis_compared_the_safety_and_effectiveness_of_the_AirSeal_system_with_traditional_pneumoperitoneum_systems_in_robot-assisted_laparoscopic_urologic_surgery

A systematic review and meta-analysis compared the ... A combined examination of the studies found that the AirSeal system had superior results in terms of surgery duration, end-tidal carbon dioxide ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011384024001904

Instrument failures for the AirSeal device: A Food and Drug ... We examined the safety profile of the AirSeal device by searching for reports and data within the MAUDE database and analyzing the reported cases.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881696/

Comparison of AirSeal versus conventional insufflation system ... AirSeal insufflation system exhibited similar efficacy and improved safety for retroperitoneal robot-assisted laparoscopic partial nephrectomy than ...