Low Pressure Pneumoperitoneum and Postoperative Ileus
This study is looking at how different levels of pressure during laparoscopic (minimally invasive) surgery for large bowel conditions like tumors or polyps might affect your recovery. Specifically, it's comparing "low pressure" (8-12 mmHg) versus "high pressure" (15 mmHg or more) pneumoperitoneum (inflating the abdomen with gas). Researchers want to see if lower pressure helps prevent postoperative ileus (when your bowels slow down after surgery) and helps you recover faster. The study also looks at different types of neuromuscular blockade (medicines like rocuronium to relax muscles during surgery) and their reversal agents (Neostigmine or Sugammadex). You could be eligible if you are an adult (18+) having laparoscopic surgery for a right hemicolectomy or sigmoid resection. The study aims to measure how quickly your digestive system recovers and if you develop postoperative ileus. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 125 participants. It compares different pressure levels during surgery and different muscle relaxant reversal medications.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your gastrointestinal function recovery will be assessed for up to 30 days after surgery, and postoperative ileus will be checked for up to 4 days after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Low Pressure Pneumoperitoneum and Postoperative Ileus
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Fedias L Christofi, Ph.D., AGAF · PRINCIPAL_INVESTIGATOR · Ohio State University
Who to contact
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What this trial measures
- Length of time (hours) of postoperative gastrointestinal tract (GIT) function recoveryUp to 30 days after surgery. From "end of surgery" to "readiness for hospital discharge", i.e., physician discharge order (assessed up to 30 days after surgery).
"Time from end of surgery to readiness for discharge" is used as a quantitative measure of postoperative gastrointestinal tract (GIT) function recovery and hence the length of postoperative ileus, and is an outcome used universally to estimate recovery of GIT function. The decision to discharge the patient ('time to discharge after surgery') by the physician is based on both the time of first spontaneous bowel movement after surgery (or flatus) and ability to tolerate a solid meal without vomiting/nausea. This parameter (time to discharge) can be measured reliably in every patient and in all 125 patients planned for enrollment in the study, increasing our chances of being able to detect differences between high and low pressure pneumoperitoneum.
- Number of participants with postoperative ileusUp to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.
Postoperative diagnosis of ileus by Day 4 after surgery (as defined by Vather et al. 2013). Reference: Defining Postoperative ileus: results of a systemic review and global survey. Journal of GI surgery, 2013. 17(5):p962-972.