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Low Pressure Pneumoperitoneum for Postoperative Ileus

N/A
Waitlist Available
Led By Fedias L Christofi, Ph.D., AGAF
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing sigmoid resection to remove polyps, diverticula or tumors
Patients undergoing laparoscopic right hemicolectomy to remove tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 days after surgery. from the "end of surgery" to postoperative day 4.
Awards & highlights

Study Summary

This trial is testing whether 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.

Who is the study for?
Adults over 18 needing laparoscopic surgery for large bowel issues like tumors or polyps can join. They must agree to participate and not have inflammatory bowel disease, past major abdominal surgeries (except appendectomies/hernia repairs), conditions affecting drug metabolism, significant other illnesses, certain pre-surgery imbalances, a history of intestinal adhesions, or allergies to specific drugs used in the study.Check my eligibility
What is being tested?
The trial is testing if using lower pressure inside the abdomen during surgery leads to quicker recovery from postoperative ileus (bowel paralysis) and gastrointestinal dysfunction. It compares high vs low pressures with different devices that control this pressure during laparoscopic bowel resections.See study design
What are the potential side effects?
Possible side effects may include discomfort at insufflation sites, variations in blood pressure or heart rate due to changes in abdominal pressure, pain after surgery related to gas insufflation technique used, and potential reactions to neuromuscular blockade reversal agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery to remove growths or pouches in my lower colon.
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I am having a laparoscopic surgery to remove a tumor in the right side of my colon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 days after surgery. from the "end of surgery" to postoperative day 4.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 days after surgery. from the "end of surgery" to postoperative day 4. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery
Number of participants with postoperative ileus
Secondary outcome measures
Number of participants with delayed postoperative ileus
Number of participants with postoperative ileus as only complication
Time the participants will need to have their first bowel movement occurrence after surgery
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3B: AirSeal® Pneumoperitoneum and Deep BlockadeExperimental Treatment4 Interventions
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.
Group II: Arm 3A: Conventional Pneumoperitoneum and Deep BlockadeExperimental Treatment4 Interventions
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.
Group III: Arm 2B: AirSeal® Pneumoperitoneum and Moderate BlockadeExperimental Treatment4 Interventions
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.
Group IV: Arm 2A: Conventional Pneumoperitoneum and Moderate BlockadeExperimental Treatment4 Interventions
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.
Group V: Arm 1: Standard of CareActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumoperitoneum Pressure
2017
N/A
~100

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
824 Previous Clinical Trials
501,438 Total Patients Enrolled
Fedias L Christofi, Ph.D., AGAFPrincipal InvestigatorOhio State University

Media Library

Neuromuscular blockade Clinical Trial Eligibility Overview. Trial Name: NCT05344417 — N/A
Paralytic Ileus Research Study Groups: 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
Paralytic Ileus Clinical Trial 2023: Neuromuscular blockade Highlights & Side Effects. Trial Name: NCT05344417 — N/A
Neuromuscular blockade 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344417 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for enrolment in the current clinical trial?

"According to clinicaltrials.gov, the patient recruitment period for this medical trial has already concluded; it was initially posted on December 30th 2022 and last updated on September 14th 2022. Nonetheless, there are currently 35 other similar studies actively seeking participants."

Answered by AI

What are the hoped-for end results of this research?

"This clinical trial seeks to measure postoperative gastrointestinal tract (GIT) function recovery over a period of up to 30 days from the end of surgery. Secondary outcomes include the time taken for participants to experience their first bowel movement and flatus after surgery, as well as calculate the number with delayed postoperative ileus defined by an inability to consume solid foods, take anything orally or require nasogastric tube insertion past day five."

Answered by AI
~83 spots leftby Dec 2024