Low Pressure Pneumoperitoneum and Postoperative Ileus
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
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 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.