Clinical trial NCT05344417: Low Pressure Pneumoperitoneum and Postoperative Ileus
Official title: Impact of Low Pressure Pneumoperitoneum on Postoperative Ileus and Gastrointestinal Dysfunction in Patients Undergoing Laparoscopic Large Bowel Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Ileus
Gastrointestinal Dysfunction
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Adult patients \> 18 years old of both sexes who consent to participate in the study and do not have any of the exclusion criteria.
2. Patients undergoing laparoscopic right hemicolectomy to remove tumors.
3. Patients undergoing sigmoid resection to remove polyps, diverticula or tumors.

Exclusion Criteria:

1. History of inflammatory bowel disease.
2. History of intestinal ischemia.
3. History of intestinal adhesions and adhesive disease.
4. Patients with a history of bowel resection or major abdominal surgery in the past. Appendectomies and hernia repairs are not considered exclusion criteria.
5. 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.
6. Significant acid-base and electrolyte imbalance before surgery as determined by the study personnel at the screening stage.
7. Allergy to or contraindications to rocuronium, or sugammadex.
8. Patients affected by medical conditions or receiving drugs that may prolong or shorten the duration of rocuronium effect (i.e. aminoglycosides, magnesium).
9. Significant comorbid conditions as determined by the study personnel at the screening stage.
10. Patients receiving any drugs that may significantly alter the picture of postoperative ileus (determined by the investigators) will be excluded from the study.
11. Prisoners and pregnant patients

Primary outcomes:
measure: Length of time (hours) of postoperative gastrointestinal tract (GIT) function recovery
timeFrame: Up 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).
measure: Number of participants with postoperative ileus
timeFrame: Up to 4 days after surgery. From the "end of surgery" to Postoperative Day 4.
Secondary outcomes:
measure: Number of participants with delayed postoperative ileus
timeFrame: Up to 5 days after surgery. From the "end of Surgery" to 5 days post-surgery as defined by Vather et al. (2013).
measure: Time the participants will need to recover oral tolerance after surgery
timeFrame: Up to 30 days after surgery. From the "end of surgery" to first tolerated solid meal (assessed up to 30 days after surgery).
measure: Time the participants will need to have their first bowel movement occurrence after surgery
timeFrame: Up to 30 days after surgery. From the "end of surgery" to first spontaneous bowel movement (assessed up to 30 days after surgery).
measure: Time the participants will need to have their first flatus after surgery
timeFrame: Up to 30 days after surgery. From the "end of surgery" to first spontaneous flatus (assessed up to 30 days after surgery).
measure: Number of participants with postoperative ileus as only complication
timeFrame: Up 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).
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Tzagournis Medical Research Facility
state: Ohio
Study officials:
affiliation: Ohio State University
name: Fedias L Christofi, Ph.D., AGAF
role: PRINCIPAL_INVESTIGATOR
References: