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NCT05344417 · ClinicalTrials.gov registry record · NA
Low Pressure Pneumoperitoneum and Postoperative Ileus
A NA study of Gastrointestinal Dysfunction and Postoperative Ileus, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 125
- Enrollment target
- 2
- Study locations
NCT05344417 is a NA study of Gastrointestinal Dysfunction and Postoperative Ileus that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 125 participants, above the 52-participant average among 4 other Gastrointestinal Dysfunction trials with a reported enrollment target (140% higher). The trial reports 2 study locations across 1 state.
The verdict
NCT05344417, a NA study of Gastrointestinal Dysfunction and Postoperative Ileus, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
- 2
- Study locations
Study 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 add
Conditions Studied
Interventions
- PROCEDURE Pneumoperitoneum Pressure
- PROCEDURE Neuromuscular blockade
- DEVICE Pneumoperitoneum insufflation device
- DRUG Neuromuscular blockade reversal
Study Locations (2)
Ohio
- The Ohio State University Wexner Medical Center - Columbus
- Tzagournis Medical Research Facility - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2024-03-06 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05344417
The ClinicalTrials.gov registry entry for NCT05344417 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 52-participant average among 4 other Gastrointestinal Dysfunction trials with a reported enrollment target (140% higher). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Gastrointestinal Dysfunction appearing as the primary indexed condition, and to 4 interventions - of which Pneumoperitoneum Pressure is the first listed.
NCT05344417 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT05344417 about?
NCT05344417 is a clinical study titled "Low Pressure Pneumoperitoneum and Postoperative Ileus". 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 i...
What is the current status of trial NCT05344417?
This trial is currently recruiting. It is a NA study. The enrollment target is 125 participants. The study started on 2024-03-06. Estimated completion is 2027-07-31.
What conditions does trial NCT05344417 study?
This clinical trial studies the following conditions: Gastrointestinal Dysfunction, Postoperative Ileus.
What interventions are being tested in trial NCT05344417?
The interventions under investigation include: Pneumoperitoneum Pressure (PROCEDURE), Neuromuscular blockade (PROCEDURE), Pneumoperitoneum insufflation device (DEVICE), Neuromuscular blockade reversal (DRUG).
Who is sponsoring clinical trial NCT05344417?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05344417 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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