Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05344417

Impact of Low Pressure Pneumoperitoneum on Postoperative Ileus and Gastrointestinal Dysfunction in Patients Undergoing Laparoscopic Large Bowel Surgery

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

125

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different pressures used during laparoscopic large bowel surgery on postoperative ileus and bowel function recovery. This study focuses on adult patients undergoing laparoscopic right hemicolectomy or sigmoid resection. The goal is to understand how high or low intraperitoneal pressure and pressure variations impact the duration of postoperative ileus, time to hospital discharge, and gastrointestinal dysfunction after surgery. Both the type of gas insufflation device and neuromuscular blockade reversal drugs are being studied as part of this research. Participants are randomly assigned to one of five groups that differ by pneumoperitoneum pressure level (high at 15 mmHg or low at 8-12 mmHg), type of insufflation device (AirSeal® device or standard Olympus device), and neuromuscular blockade depth and reversal drug used. High pressure groups use moderate neuromuscular blockade reversed with either neostigmine or sugammadex, while low pressure groups use deep neuromuscular blockade reversed with sugammadex. The study will monitor intrabdominal pressure changes throughout surgery and compare outcomes across these arms. During the study, participants will have their recovery monitored up to 30 days after surgery, including time to gastrointestinal function recovery and readiness for hospital discharge. Clinical data will be collected from medical charts and biological samples taken during surgery, such as peritoneal lavage fluid, serum, and bowel tissue. Researchers will analyze inflammatory markers and perform various laboratory tests to explore mechanisms related to postoperative ileus. Safety and effects on hemodynamic and respiratory parameters during surgery will also be recorded.

CONDITIONS

Brief 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 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 appendectomies and hernia repairs)
  • Use of epidural catheters for postoperative pain control during the study
  • 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 comorbid conditions as determined at screening
  • Use of drugs that significantly alter postoperative ileus
  • Prisoners and pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo laparoscopic large bowel surgery with assigned pneumoperitoneum pressure and neuromuscular blockade. Surgical procedures include right hemi-colectomies or sigmoid resections. Immediate post-operative care includes monitoring recovery from surgery.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days after surgery

Participants are monitored for postoperative gastrointestinal function recovery and ileus. Clinical data and various biological samples are collected to evaluate recovery and complications.

Daily visits or assessments for up to 5 days, with follow-up visits up to 30 days after surgery

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

A

Alberto Uribe, MD

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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