Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2024-03-06
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Exclusion Criteria
3. Patients undergoing sigmoid resection to remove polyps, diverticula or tumors.
1. History of inflammatory bowel disease.
2. History of intestinal ischemia.
3. History of intestinal adhesions and adhesive disease.
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
18 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Fedias Christofi
Professor and Vice Chair of Research
Principal Investigators
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Fedias L Christofi, Ph.D., AGAF
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Tzagournis Medical Research Facility
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021H0262
Identifier Type: -
Identifier Source: org_study_id
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