Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05344417

Low Pressure Pneumoperitoneum and Postoperative Ileus

Led by Ohio State University · Updated on 2025-11-03

125

Participants Needed

2

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Low Pressure Pneumoperitoneum and Postoperative Ileus

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years old of any gender who consent to participate
  • Patients undergoing laparoscopic right hemicolectomy to remove tumors
  • Patients undergoing laparoscopic sigmoid resection to remove polyps, diverticula, or tumors
Not Eligible

You will not qualify if you...

  • History of inflammatory bowel disease
  • History of intestinal ischemia
  • History of intestinal adhesions or adhesive disease
  • History of bowel resection or major abdominal surgery (excluding appendectomy or hernia repair)
  • Use of epidural catheters for postoperative pain control during the study period
  • Significant acid-base or electrolyte imbalance before surgery
  • Allergy or contraindication to rocuronium or sugammadex
  • Medical conditions or medications that affect the duration of rocuronium
  • Significant other comorbid conditions as determined by study personnel
  • Use of drugs that may alter postoperative ileus
  • Prisoners or pregnant patients

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Trial Site Locations

Total: 2 locations

1

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Not Yet Recruiting

2

Tzagournis Medical Research Facility

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

F

Fedias L Christofi, Ph.D., AGAF

CONTACT

A

Alberto Uribe, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

5

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