Low Pressure Pneumoperitoneum for Postoperative Ileus

Recruiting at 1 trial location

Overseen by Fedias L Christofi, Ph.D., AGAF

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators are testing the hypothesis that lower pressure pneumoperitoneum during laparoscopic large bowel surgery protects the bowel from postoperative ileus and bowel dysfunction leading to faster recovery and discharge from the hospital. 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 hospital discharge, and postoperative gastrointestinal dysfunction in adult patients undergoing laparoscopic large bowel resection (i.e., sigmoidectomy and right colectomy). A randomized parallel group study will be conducted involving 5 arms of surgical patients to test whether differences on postoperative ileus outcome parameters occur between high (15 mm Hg) and low pressure pneumoperitoneum (8-12 mm Hg), as well as whether there are differences between the 2 insufflation devices that provide constant or variable intrabdominal pressure throughout the laparoscopic surgery. For high pressure pneumoperitoneum, either neostigmine or sugammadex are used for reversal of moderate neuromuscular blockade. For low pressure pneumoperitoneum, sugammadex is used for reversal of deep neuromuscular blockade. The investigators plan to use 2 types of gas insufflation devices, one of which will provide a relatively stable pressure level throughout surgery (AirSeal® device), and the second one will provide a more variable pressure (Olympus standard insufflation device). Using both pressure modalities, the investigators will study the effects of different pressure characteristics on the course of postoperative ileus, duration of in-hospital treatment, pain level, and the stability of hemodynamic and respiratory parameters during surgery. Changes in intrabdominal pressure during the surgery will be monitored and recorded using a custom software for later analysis of fluctuations in pressure to relate them to outcomes. Other parameters will be obtained from EPIC (IHIS) medical charts. 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.

Research Team

Fedias L Christofi, Ph.D., AGAF

Principal Investigator

Ohio State University

Eligibility Criteria

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 over 18 and agree to participate in the study without any disqualifying conditions.

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

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

Treatment Details

Interventions

• Neuromuscular blockade (Procedure)
• Neuromuscular blockade reversal (Drug)
• Pneumoperitoneum insufflation device (Device)
• Pneumoperitoneum Pressure (Procedure)

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.

Participant Groups

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+