Status:
RECRUITING
Low Pressure Pneumoperitoneum and Postoperative Ileus
Lead Sponsor:
Ohio State University
Conditions:
Postoperative Ileus
Gastrointestinal Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- Adult patients \> 18 years old of both sexes who consent to participate in the study and do not have any of the exclusion criteria.
- Patients undergoing laparoscopic right hemicolectomy to remove tumors.
- Patients undergoing sigmoid resection to remove polyps, diverticula or tumors.
Exclusion
- History of inflammatory bowel disease.
- History of intestinal ischemia.
- History of intestinal adhesions and adhesive disease.
- Patients with a history of bowel resection or major abdominal surgery in the past. Appendectomies and hernia repairs are not considered exclusion criteria.
- 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.
- Significant acid-base and electrolyte imbalance before surgery as determined by the study personnel at the screening stage.
- Allergy to or contraindications to rocuronium, or sugammadex.
- Patients affected by medical conditions or receiving drugs that may prolong or shorten the duration of rocuronium effect (i.e. aminoglycosides, magnesium).
- Significant comorbid conditions as determined by the study personnel at the screening stage.
- Patients receiving any drugs that may significantly alter the picture of postoperative ileus (determined by the investigators) will be excluded from the study.
- Prisoners and pregnant patients
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05344417
Start Date
March 6 2024
End Date
July 31 2027
Last Update
November 3 2025
Active Locations (2)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
2
Tzagournis Medical Research Facility
Columbus, Ohio, United States, 43210