Your session is about to expire
← Back to Search
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
Must not have
History of intestinal adhesions and adhesive disease
History of inflammatory bowel disease
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
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 belowSelect...
I am having surgery to remove growths or pouches in my lower colon.
Select...
I am having a laparoscopic surgery to remove a tumor in the right side of my colon.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of intestinal adhesions.
Select...
I have a history of inflammatory bowel disease.
Select...
I have had a condition where my intestines didn't get enough blood.
Select...
I am not allergic to rocuronium or sugammadex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 days after surgery. from the "end of surgery" to postoperative day 4.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 days after surgery. from the "end of surgery" to postoperative day 4.
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 moreTrial 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
844 Previous Clinical Trials
639,384 Total Patients Enrolled
Fedias L Christofi, Ph.D., AGAFPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of intestinal adhesions.I have a history of inflammatory bowel disease.I am taking medication or have a condition that affects how long muscle relaxants work for me.I am over 18 and agree to participate in the study without any disqualifying conditions.I have had major abdominal surgery, but not an appendectomy or hernia repair.I am using an epidural catheter for pain after surgery.I am having surgery to remove growths or pouches in my lower colon.I am having a laparoscopic surgery to remove a tumor in the right side of my colon.I have had a condition where my intestines didn't get enough blood.I am not taking medication that affects post-surgery intestine recovery.I am not allergic to rocuronium or sugammadex.My blood tests show normal levels of salts and pH before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade
- Group 2: Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade
- Group 3: Arm 3A: Conventional Pneumoperitoneum and Deep Blockade
- Group 4: Arm 1: Standard of Care
- Group 5: Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger