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Low Pressure Pneumoperitoneum and Postoperative Ileus

RecruitingNAAges 18 Years - anyAllOhio State University
NCT05344417 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 provid

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📋 Eligibility rules (as published)
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
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What it tests

  • Pneumoperitoneum Pressure
  • Neuromuscular blockade
  • Pneumoperitoneum insufflation device
  • Neuromuscular blockade reversal
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Where

2 sites
The Ohio State University Wexner Medical Center
Columbus, United States
Tzagournis Medical Research Facility
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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