Low Pressure Pneumoperitoneum and Postoperative Ileus

Conditions

• Gastrointestinal Dysfunction
• Postoperative Ileus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pneumoperitoneum Pressure — PROCEDURE
  Low Pneumoperitoneum Pressure: defined as an intrabdominal pressure between 8-12 mmHg during the laparoscopic procedure. High Pneumoperitoneum pressure: defined as an intrabdominal pressure of 15 mmHg or more during the laparoscopic procedure. Note: surgeons will set the pneumoperitoneum at the lowest value they are comfortable with based on their surgical criteria
• Neuromuscular blockade — PROCEDURE
  Moderate neuromuscular blockade: defined as the presence of 1 or 2 responses after train-of-four stimulation. Deep neuromuscular blockade: defined as no response to train-of-four stimulation and 1 or less responses after post-tetanic count stimulation.
• Pneumoperitoneum insufflation device — DEVICE
  AirSeal® device or Olympus "standard of care" insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries.
• Neuromuscular blockade reversal — DRUG
  Neostigmine: for Arm 1 only (standard use). Sugammadex: will be used for the other arms in the study. All drugs used in our randomized trial (neuromuscular blockade with rocuronium and reversal with neostigmine or sugammadex) are standard of care and approved for use by our institutional Institutional Review Board (IRB) Ethics Committee for this trial.

Study Details

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.

Key Dates

Start date

Mar 6, 2024

Status verified

Oct 2025

Primary completion

Dec 30, 2026

Completion

Jul 31, 2027

Study Design

Enrollment

125 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• No Intervention: Arm 1: Standard of Care
  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.
• Experimental: Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade
  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.
• Experimental: Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade
  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.
• Experimental: Arm 3A: Conventional Pneumoperitoneum and Deep Blockade
  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.
• Experimental: Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade
  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.

Primary Outcome Measure

Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery [ Time Frame: Up to 30 days after surgery. From "end of surgery" to "readiness for hospital discharge", i.e., physician discharge order (assessed up to 30 days after surgery). ]

Central Contacts

• Fedias L Christofi, Ph.D., AGAF
  614-688-3802
  [email protected]
• Alberto Uribe, MD
  614-293-3559
  [email protected]

Locations (2)

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