Recruiting

Pneumoperitoneum Pressure

Sponsor:

Ohio State University

Code:

NCT05344417

Conditions

Postoperative Ileus

Gastrointestinal Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pneumoperitoneum Pressure

Neuromuscular blockade

Pneumoperitoneum insufflation device

Neuromuscular blockade reversal

Study Details

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 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 provide constant or variable intrabdominal pressure throughout the laparoscopic surgery. For high pressure pneumoperitoneum, either neostigmine or sugammadex are used for reversal of moderate neuromuscular blockade. For low pressure pneumoperitoneum, sugammadex is used for reversal of deep neuromuscular blockade. The investigators plan to use 2 types of gas insufflation devices, one of which will provide a relatively stable pressure level throughout surgery (AirSeal® device), and the second one will provide a more variable pressure (Olympus standard insufflation device). Using both pressure modalities, the investigators will study the effects of different pressure characteristics on the course of postoperative ileus, duration of in-hospital treatment, pain level, and the stability of hemodynamic and respiratory parameters during surgery. Changes in intrabdominal pressure during the surgery will be monitored and recorded using a custom software for later analysis of fluctuations in pressure to relate them to outcomes. Other parameters will be obtained from EPIC (IHIS) medical charts. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Conditions

Postoperative Ileus

Gastrointestinal Dysfunction

Study ID

NCT05344417

Start date

Mar 6, 2024

Status verified date

Oct, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Arm 1: Standard of Care

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with conventional insufflation under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with neostigmine. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

experimental: Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with conventional insufflation under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

experimental: Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using high pneumoperitoneum pressure with AirSeal® trademark (TM) system under moderate neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

experimental: Arm 3A: Conventional Pneumoperitoneum and Deep Blockade

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using low pneumoperitoneum pressure with conventional insufflation under deep neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

experimental: Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade

25 patients undergoing laparoscopic right hemi-colectomies or sigmoid resections using low pneumoperitoneum pressure with AirSeal® TM system under deep neuromuscular blockade with rocuronium and neuromuscular blockade reversal with sugammadex. In addition, clinical data on postoperative ileus will be correlated with experimental outcomes from in vitro exploratory studies done using human samples of peritoneal lavage fluid, serum, and a small portion of the surgically removed bowel from each patient (that is otherwise discarded). A panel of inflammatory markers will be analyzed and biochemical, imaging, histological, immunochemical, molecular signaling, and glial activation studies will be done to evaluate the potential mechanisms of dysfunction associated with postoperative ileus.

Interventions

Pneumoperitoneum Pressure

Low Pneumoperitoneum Pressure: defined as an intrabdominal pressure between 8-12 mmHg during the laparoscopic procedure.

High Pneumoperitoneum pressure: defined as an intrabdominal pressure of 15 mmHg or more during the laparoscopic procedure.

Note: surgeons will set the pneumoperitoneum at the lowest value they are comfortable with based on their surgical criteria

Neuromuscular blockade

Moderate neuromuscular blockade: defined as the presence of 1 or 2 responses after train-of-four stimulation.

Deep neuromuscular blockade: defined as no response to train-of-four stimulation and 1 or less responses after post-tetanic count stimulation.

Pneumoperitoneum insufflation device

AirSeal® device or Olympus "standard of care" insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries.

Neuromuscular blockade reversal

Neostigmine: for Arm 1 only (standard use).

Sugammadex: will be used for the other arms in the study.

All drugs used in our randomized trial (neuromuscular blockade with rocuronium and reversal with neostigmine or sugammadex) are standard of care and approved for use by our institutional Institutional Review Board (IRB) Ethics Committee for this trial.

Primary outcome measure

  • Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery [ Time Frame: Up to 30 days after surgery. From "end of surgery" to "readiness for hospital discharge", i.e., physician discharge order (assessed up to 30 days after surgery). ]
  • Number of participants with postoperative ileus [ Time Frame: Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4. ]

Central Contacts and Locations

Central contacts

Locations

Tzagournis Medical Research Facility

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Fedias L Christofi, Ph.D., AGAF

614-688-3802fedias.christofi@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-11-03.