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New treatment option for Postoperative Ileus
Official title Low Pressure Pneumoperitoneum and Postoperative Ileus
ClinicalTrials.gov ID: NCT05344417
What this study is testing
What is Neuromuscular blockade reversal?
Neuromuscular blockade reversal is an investigational medicine, being studied as a potential treatment for postoperative ileus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1. Adult patients \> 18 years old of both sexes who consent to participate in the study and do not have any of the
You likely can't join if
- 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...
See the full eligibility criteria
- 1. Adult patients \> 18 years old of both sexes who consent to participate in the study and do not have any of the
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.