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Search / Trial NCT05344417

Low Pressure Pneumoperitoneum and Postoperative Ileus

Launched by OHIO STATE UNIVERSITY · Apr 19, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether using lower air pressure during laparoscopic surgery on the large bowel can help patients recover faster and reduce the chances of developing postoperative ileus, which is a condition that affects how the bowel functions after surgery. The researchers will compare two different pressure levels—high pressure (15 mm Hg) and low pressure (8-12 mm Hg)—to see how they impact recovery time, pain levels, and bowel function in adult patients undergoing surgeries like sigmoidectomy and right colectomy. They will also analyze different devices that maintain either stable or variable pressure during surgery to determine which is more effective.

To be eligible for this study, participants must be adults over 18 years old who are undergoing specific types of laparoscopic bowel surgery and do not have certain health issues, such as inflammatory bowel disease or a history of major abdominal surgeries. If you join the trial, you can expect to be monitored closely during and after your surgery, with researchers collecting data to understand how the different pressure levels and devices affect your recovery. This study aims to find better ways to help patients heal after surgery, making their hospital stay shorter and more comfortable.

Gender

ALL

Eligibility criteria

  • 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

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Columbus, Ohio, United States

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Fedias L Christofi, Ph.D., AGAF

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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