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

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

This trial will test whether using lower abdominal inflation pressure during laparoscopic large-bowel surgery helps adults recover bowel function faster and go home sooner.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University (other)
• Locations: 2 sites (Columbus, Ohio and 1 other locations)
• Trial ID: NCT05344417 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 years scheduled for elective laparoscopic right hemicolectomy or sigmoid resection who meet inclusion criteria and consent to participate.

Not a fit: Patients with inflammatory bowel disease, intestinal ischemia, significant adhesive disease, prior major abdominal resections, or those requiring epidural analgesia are excluded and therefore unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could shorten time to bowel function recovery and reduce length of hospital stay after laparoscopic large-bowel surgery.

How similar studies have performed: Previous laparoscopic studies have suggested low-pressure pneumoperitoneum can reduce postoperative pain and aid recovery, but evidence specifically showing reduced postoperative ileus is limited.

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

Where this trial is running

Columbus, Ohio and 1 other locations

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (NOT_YET_RECRUITING)
• Tzagournis Medical Research Facility — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Fedias L Christofi, Ph.D., AGAF — Ohio State University
• Study coordinator: Fedias L Christofi, Ph.D., AGAF

Conditions: Postoperative Ileus, Gastrointestinal Dysfunction