Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorReuven Pizov
About this trial
Evaluate early postoperative complications after surgery in Trendelenburg position with increased intraabdominal pressure (surgery with pneumoperitoneum). Evaluate the relationship between hemodynamic and metabolic changes on perioperative outcome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA Class I-IV.
Planned for laparoscopic surgery in the Trendelenburg position that is expected to last more than 2 hours.
Planned arterial catheter insertion.
Disqualifiers
Pregnancy.
Planned open abdominal surgery.
Renal Replacement Therapy.
Trial population
Adult patients who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic Surgery
Procedure/SurgeryLaparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Perioperative change in urine NGAL
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a urine sample taken from a Foley catheter
Time frame
Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery2
Acute Kidney Injury
According to the KDIGO acute renal injury stage
Time frame
2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.3
Perioperative change in serum NGAL
Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample
Time frame
Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery4
Perioperatitve change in serum concentration of Cannabidiol
Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample
Time frame
Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgerySecondary outcomes
1
Delirium
As assessed by CAM-ICU
Time frame
Within 7 days after surgery2
CVA / TIA
New diagnosis of cerebrovascular accident or transient ischemic attack
Time frame
Within 30 days after surgery3
Myocardial Ischemia
New myocardial ischemia, as diagnosed by ecg or serum troponin
Time frame
During hospital stay, within 30 days after surgery4
Arrhythmia
New clinically significant arrhythmia
Time frame
During hospital stay, within 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Reuven Pizov
Lead sponsor
Hadassah Medical Organization
Sponsor institution
Source ClinicalTrials.gov