Postoperative IleusNCT05344417
Low Pressure Pneumoperitoneum and Postoperative Ileus
A study testing Pneumoperitoneum Pressure, Neuromuscular blockade and Pneumoperitoneum insufflation device in people with Postoperative Ileus and Gastrointestinal Dysfunction, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Gastrointestinal Dysfunction
- What is being tested?
- Pneumoperitoneum Pressure, Neuromuscular blockade and Pneumoperitoneum insufflation device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Mar 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alberto Uribe, MD, 614-293-3559, alberto.uribe@osumc.edu
Juan Fiorda Diaz, MD, 614-366-8397, juan.fiordadiaz@osumc.edu
- Recruiting
Tzagournis Medical Research Facility
Columbus, Ohio, 43210
Fedias L Christofi, Ph.D., AGAF, 614-688-3802, fedias.christofi@osumc.edu
About this study
Official title: Impact of Low Pressure Pneumoperitoneum on Postoperative Ileus and Gastrointestinal Dysfunction in Patients Undergoing Laparoscopic Large Bowel Surgery
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
- Being tested
- Pneumoperitoneum Pressure, Neuromuscular blockade, Pneumoperitoneum insufflation device, Neuromuscular blockade reversal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum PressureProcedure or surgery
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 blockadeProcedure or surgery
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 deviceDevice
AirSeal® device or Olympus "standard of care" insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries.
Neuromuscular blockade reversalDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard of Care | No intervention | 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. |
| Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade | Experimental | 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. Receives: Procedure: Pneumoperitoneum Pressure; Procedure: Neuromuscular blockade; Device: Pneumoperitoneum insufflation device; Drug: Neuromuscular blockade reversal |
| Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade | Experimental | 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. Receives: Procedure: Pneumoperitoneum Pressure; Procedure: Neuromuscular blockade; Device: Pneumoperitoneum insufflation device; Drug: Neuromuscular blockade reversal |
| Arm 3A: Conventional Pneumoperitoneum and Deep Blockade | Experimental | 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. Receives: Procedure: Pneumoperitoneum Pressure; Procedure: Neuromuscular blockade; Device: Pneumoperitoneum insufflation device; Drug: Neuromuscular blockade reversal |
| Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade | Experimental | 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. Receives: Procedure: Pneumoperitoneum Pressure; Procedure: Neuromuscular blockade; Device: Pneumoperitoneum insufflation device; Drug: Neuromuscular blockade reversal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery
"Time from end of surgery to readiness for discharge" is used as a quantitative measure of postoperative gastrointestinal tract (GIT) function recovery and hence the length of postoperative ileus, and is an outcome used universally to estimate recovery of GIT function. The decision to discharge the patient ('time to discharge after surgery') by the physician is based on both the time of first spontaneous bowel movement after surgery (or flatus) and ability to tolerate a solid meal without vomiting/nausea. This parameter (time to discharge) can be measured reliably in every patient and in all 125 patients planned for enrollment in the study, increasing our chances of being able to detect differences between high and low pressure pneumoperitoneum.
Measured: 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
Postoperative diagnosis of ileus by Day 4 after surgery (as defined by Vather et al. 2013). Reference: Defining Postoperative ileus: results of a systemic review and global survey. Journal of GI surgery, 2013. 17(5):p962-972.
Measured: Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.
Secondary outcomes (5)
Number of participants with delayed postoperative ileus
This is calculated as the percent of subjects with postoperative gastrointestinal dysfunction (POGD) ≥5 days defined as subjects unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of nasogastric tube at or after 5 days post-surgery
Measured: Up to 5 days after surgery. From the "end of Surgery" to 5 days post-surgery as defined by Vather et al. (2013).
Time the participants will need to recover oral tolerance after surgery
Time to first tolerated solid meal: defined as the time each participant will take to eat the first solid meal without experiencing clinically significant nausea and/or vomiting for 1 calendar day after the meal.
Measured: Up to 30 days after surgery. From the "end of surgery" to first tolerated solid meal (assessed up to 30 days after surgery).
Time the participants will need to have their first bowel movement occurrence after surgery
The time participants will take to experience their first bowel movement occurrence after surgery. This outcome is one of the main clinical signs of postoperative gastrointestinal function recovery.
Measured: Up to 30 days after surgery. From the "end of surgery" to first spontaneous bowel movement (assessed up to 30 days after surgery).
Time the participants will need to have their first flatus after surgery
The time participants will take to experience their first flatus occurrence after surgery. This outcome is one of the main clinical signs of postoperative gastrointestinal function recovery.
Measured: Up to 30 days after surgery. From the "end of surgery" to first spontaneous flatus (assessed up to 30 days after surgery).
Number of participants with postoperative ileus as only complication
Investigators will report the incidence of postoperative ileus as the only postoperative complication (i.e. isolated postoperative ileus without any other concomitant complication) which may offer significant information about the impact of postoperative ileus on delayed gastrointestinal tract recovery and length of hospital stay.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start6 Mar 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fedias Christofi, Ohio State University
- Investigators
- Fedias L Christofi, Ph.D., AGAF, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344417
- Sponsor's protocol ID
- 2021H0262
- Status last verified
- Oct 2025
- First submitted
- 31 Mar 2022
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Pressure Pneumoperitoneum on Postoperative Ileus and Gastrointestinal Dysfunction in Patients Undergoing Laparoscopic Large Bowel Surgery
- ClinicalTrials.gov ID
- NCT05344417
- Acronym / sponsor ID
- 2021H0262
- Conditions
- Postoperative Ileus, Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard of Care | No intervention | –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. |
| Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade | Experimental | Procedure: Pneumoperitoneum Pressure, Procedure: Neuromuscular blockade, Device: Pneumoperitoneum insufflation device, Drug: Neuromuscular blockade reversal25 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. |
| Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade | Experimental | Procedure: Pneumoperitoneum Pressure, Procedure: Neuromuscular blockade, Device: Pneumoperitoneum insufflation device, Drug: Neuromuscular blockade reversal25 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. |
| Arm 3A: Conventional Pneumoperitoneum and Deep Blockade | Experimental | Procedure: Pneumoperitoneum Pressure, Procedure: Neuromuscular blockade, Device: Pneumoperitoneum insufflation device, Drug: Neuromuscular blockade reversal25 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. |
| Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade | Experimental | Procedure: Pneumoperitoneum Pressure, Procedure: Neuromuscular blockade, Device: Pneumoperitoneum insufflation device, Drug: Neuromuscular blockade reversal25 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumoperitoneum PressureLow 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 | Procedure or surgery | Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade, Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade, Arm 3A: Conventional Pneumoperitoneum and Deep Blockade, Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade |
| Neuromuscular blockadeModerate 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. | Procedure or surgery | Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade, Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade, Arm 3A: Conventional Pneumoperitoneum and Deep Blockade, Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade |
| Pneumoperitoneum insufflation deviceAirSeal® device or Olympus "standard of care" insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries. | Device | Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade, Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade, Arm 3A: Conventional Pneumoperitoneum and Deep Blockade, Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade |
| Neuromuscular blockade reversalNeostigmine: 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. | Drug | Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade, Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade, Arm 3A: Conventional Pneumoperitoneum and Deep Blockade, Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade |
Primary outcome
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).
"Time from end of surgery to readiness for discharge" is used as a quantitative measure of postoperative gastrointestinal tract (GIT) function recovery and hence the length of postoperative ileus, and is an outcome used universally to estimate recovery of GIT function. The decision to discharge the patient ('time to discharge after surgery') by the physician is based on both the time of first spontaneous bowel movement after surgery (or flatus) and ability to tolerate a solid meal without vomiting/nausea. This parameter (time to discharge) can be measured reliably in every patient and in all 125 patients planned for enrollment in the study, increasing our chances of being able to detect differences between high and low pressure pneumoperitoneum.
Number of participants with postoperative ileus
Time frame: Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.
Postoperative diagnosis of ileus by Day 4 after surgery (as defined by Vather et al. 2013). Reference: Defining Postoperative ileus: results of a systemic review and global survey. Journal of GI surgery, 2013. 17(5):p962-972.
5 secondary outcomes
Number of participants with delayed postoperative ileus
Time frame: Up to 5 days after surgery. From the "end of Surgery" to 5 days post-surgery as defined by Vather et al. (2013).
Time the participants will need to recover oral tolerance after surgery
Time frame: Up to 30 days after surgery. From the "end of surgery" to first tolerated solid meal (assessed up to 30 days after surgery).
Time the participants will need to have their first bowel movement occurrence after surgery
Time frame: Up to 30 days after surgery. From the "end of surgery" to first spontaneous bowel movement (assessed up to 30 days after surgery).
Time the participants will need to have their first flatus after surgery
Time frame: Up to 30 days after surgery. From the "end of surgery" to first spontaneous flatus (assessed up to 30 days after surgery).
Number of participants with postoperative ileus as only complication
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fedias L Christofi, Ph.D., AGAF principal investigator
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumoperitoneum Pressure, Neuromuscular blockade and Pneumoperitoneum insufflation device in people with Postoperative Ileus and Gastrointestinal Dysfunction, run by Ohio State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fedias L Christofi, Ph.D., AGAF (614-688-3802, fedias.christofi@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.