Pneumoperitoneum Pressure for Pneumoperitoneum

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tzagournis Medical Research Facility, Columbus, OH
Pneumoperitoneum+3 More
Pneumoperitoneum Pressure - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. Pneumoperitoneum Pressure will be used to treat Pneumoperitoneum in this trial, and there will be no placebo group. Pneumoperitoneum Pressure has been approved by the FDA for a different condition in the past.

Eligible Conditions

  • Pneumoperitoneum
  • Paralytic Ileus
  • Gastrointestinal Dysfunction

Treatment Effectiveness

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.

Day 30
Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery
Number of participants with postoperative gastrointestinal tract (GIT) function recovery
Number of participants with postoperative ileus as only complication
Day 30
Time the participants will need to have their first bowel movement occurrence after surgery
Day 30
Time the participants will need to have their first flatus after surgery
Day 30
Time the participants will need to recover oral tolerance after surgery
Day 4
Number of participants with postoperative ileus
Day 5
Number of participants with delayed postoperative ileus

Trial Safety

Trial Design

5 Treatment Groups

Arm 1: Standard of Care
1 of 5
Arm 3B: AirSeal® Pneumoperitoneum and Deep Blockade
1 of 5
Arm 3A: Conventional Pneumoperitoneum and Deep Blockade
1 of 5
Arm 2B: AirSeal® Pneumoperitoneum and Moderate Blockade
1 of 5
Arm 2A: Conventional Pneumoperitoneum and Moderate Blockade
1 of 5
Active Control
Experimental Treatment

125 Total Participants · 5 Treatment Groups

Primary Treatment: Pneumoperitoneum Pressure · No Placebo Group · N/A

Arm 3B: AirSeal® Pneumoperitoneum and Deep BlockadeExperimental Group · 4 Interventions: Neuromuscular blockade, Pneumoperitoneum Pressure, Pneumoperitoneum insufflation device, Neuromuscular blockade reversal · Intervention Types: Procedure, Procedure, Device, Drug
Arm 3A: Conventional Pneumoperitoneum and Deep BlockadeExperimental Group · 4 Interventions: Neuromuscular blockade, Pneumoperitoneum Pressure, Pneumoperitoneum insufflation device, Neuromuscular blockade reversal · Intervention Types: Procedure, Procedure, Device, Drug
Arm 2B: AirSeal® Pneumoperitoneum and Moderate BlockadeExperimental Group · 4 Interventions: Neuromuscular blockade, Pneumoperitoneum Pressure, Pneumoperitoneum insufflation device, Neuromuscular blockade reversal · Intervention Types: Procedure, Procedure, Device, Drug
Arm 2A: Conventional Pneumoperitoneum and Moderate BlockadeExperimental Group · 4 Interventions: Neuromuscular blockade, Pneumoperitoneum Pressure, Pneumoperitoneum insufflation device, Neuromuscular blockade reversal · Intervention Types: Procedure, Procedure, Device, Drug
Arm 1: Standard of CareNoIntervention Group · 1 Intervention: Arm 1: Standard of Care · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pneumoperitoneum Pressure
2017
N/A
~100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 days after surgery. from the "end of surgery" to postoperative day 4.
Closest Location: Tzagournis Medical Research Facility · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Pneumoperitoneum
0 CompletedClinical Trials

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
693 Previous Clinical Trials
375,181 Total Patients Enrolled
Fedias L Christofi, Ph.D., AGAFPrincipal InvestigatorOhio State University

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.