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Low Pressure Pneumoperitoneum and Postoperative Ileus

Primary Purpose

Postoperative Ileus, Gastrointestinal Dysfunction

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pneumoperitoneum Pressure
Neuromuscular blockade
Pneumoperitoneum insufflation device
Neuromuscular blockade reversal
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical Center
  • Tzagournis Medical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: Standard of Care

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

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
March 31, 2022
Last Updated
January 18, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05344417
Brief Title
Low Pressure Pneumoperitoneum and Postoperative Ileus
Official Title
Impact of Low Pressure Pneumoperitoneum on Postoperative Ileus and Gastrointestinal Dysfunction in Patients Undergoing Laparoscopic Large Bowel Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus, Gastrointestinal Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Standard of Care
Arm Type
No Intervention
Arm Description
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 Title
Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3A: Conventional Pneumoperitoneum and Deep Blockade
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pneumoperitoneum Pressure
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Neuromuscular blockade
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pneumoperitoneum insufflation device
Intervention Description
AirSeal® device or Olympus "standard of care" insufflation device. Both devices are approved for use in laparoscopic gastrointestinal surgeries.
Intervention Type
Drug
Intervention Name(s)
Neuromuscular blockade reversal
Intervention Description
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 Information:
Title
Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery
Description
"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.
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).
Title
Number of participants with postoperative ileus
Description
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.
Time Frame
Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.
Secondary Outcome Measure Information:
Title
Number of participants with delayed postoperative ileus
Description
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
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).
Title
Time the participants will need to recover oral tolerance after surgery
Description
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.
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).
Title
Time the participants will need to have their first bowel movement occurrence after surgery
Description
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.
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).
Title
Time the participants will need to have their first flatus after surgery
Description
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.
Time Frame
Up to 30 days after surgery. From the "end of surgery" to first spontaneous flatus (assessed up to 30 days after surgery).
Title
Number of participants with postoperative ileus as only complication
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fedias L Christofi, Ph.D., AGAF
Phone
614-688-3802
Email
fedias.christofi@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Uribe, MD
Phone
614-293-3559
Email
alberto.uribe@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fedias L Christofi, Ph.D., AGAF
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Uribe, MD
Phone
614-293-3559
Email
alberto.uribe@osumc.edu
First Name & Middle Initial & Last Name & Degree
Juan Fiorda Diaz, MD
Phone
614-366-8397
Email
juan.fiordadiaz@osumc.edu
Facility Name
Tzagournis Medical Research Facility
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fedias L Christofi, Ph.D., AGAF
Phone
614-688-3802
Email
fedias.christofi@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Pressure Pneumoperitoneum and Postoperative Ileus

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