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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

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:

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

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

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

NCT ID

NCT05344417

First Posted

March 31, 2022

Last Updated

January 18, 2023

Sponsor

Ohio State University

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

Arm Title

Arm 3A: Conventional Pneumoperitoneum and Deep Blockade

Arm Type

Experimental

Arm Description

Arm Title

Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade

Arm Type

Experimental

Arm Description

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 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

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

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 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

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

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

fedias.christofi@osumc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Alberto Uribe, MD

Phone

614-293-3559

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

alberto.uribe@osumc.edu

First Name & Middle Initial & Last Name & Degree

Juan Fiorda Diaz, MD

Phone

614-366-8397

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

fedias.christofi@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Low Pressure Pneumoperitoneum and Postoperative Ileus

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