Lowering abdominal gas pressure during laparoscopic large-bowel surgery to reduce postoperative ileus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group trial enrolling adults undergoing laparoscopic right hemicolectomy or sigmoid resection to compare different intraperitoneal insufflation pressures and devices. Five arms compare high pressure (15 mm Hg) versus lower pressure (8–12 mm Hg) and constant versus variable-pressure insufflation systems, with standardized neuromuscular blockade and reversal protocols. Primary outcomes include measures of postoperative ileus and gastrointestinal dysfunction, plus time to hospital discharge. The goal is to determine whether pressure level or pressure variability during surgery alters postoperative recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients \> 18 years old of both sexes who consent to participate in the study and do not have any of the exclusion criteria.
2. Patients undergoing laparoscopic right hemicolectomy to remove tumors.
3. Patients undergoing sigmoid resection to remove polyps, diverticula or tumors.

Exclusion Criteria:

1. History of inflammatory bowel disease.
2. History of intestinal ischemia.
3. History of intestinal adhesions and adhesive disease.
4. Patients with a history of bowel resection or major abdominal surgery in the past. Appendectomies and hernia repairs are not considered exclusion criteria.
5. Patients having epidural catheters placed for postoperative pain control for the study period. Intrathecal morphine injections for postoperative pain control will not exclude the patients from the study.
6. Significant acid-base and electrolyte imbalance before surgery as determined by the study personnel at the screening stage.
7. Allergy to or contraindications to rocuronium, or sugammadex.
8. Patients affected by medical conditions or receiving drugs that may prolong or shorten the duration of rocuronium effect (i.e. aminoglycosides, magnesium).
9. Significant comorbid conditions as determined by the study personnel at the screening stage.
10. Patients receiving any drugs that may significantly alter the picture of postoperative ileus (determined by the investigators) will be excluded from the study.
11. Prisoners and pregnant patients

Where it's running

• Tzagournis Medical Research Facility
  Columbus, Ohio, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Fedias L Christofi, Ph.D., AGAF — Ohio State University
• Study coordinator: Fedias L Christofi, Ph.D., AGAF
• Email: fedias.christofi@osumc.edu
• Phone: 614-688-3802

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.