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Recruiting NCT06685159

Predictors of Postoperative Complications in Surgery With Pneumoperitoneum in the Trendelenburg Position

— Observational Trendelenburg Position Pneumoperitoneum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic Surgery.
Who it may be relevant to
Registry conditions: Trendelenburg Position, Pneumoperitoneum. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Risk Factors for Postoperative Complications in Surgery With Pneumoperitoneum in Trendelenburg Position. Observational Pilot Study

Overview

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.

Interventions

  • Procedure Laparoscopic Surgery
    Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position

Primary outcome measures

  • Perioperative change in urine NGAL [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Acute Kidney Injury [Time frame: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.]
  • Perioperative change in serum NGAL [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in serum concentration of Cannabidiol [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery and 2h hours after completion of surgery]
  • Perioperatitve change in urine concentration of Cannabidiol [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in TBW [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in ECW [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in serum pH [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in serum BE [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
  • Perioperatitve change in serum lactate concentration [Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery]
Secondary outcome measures (7)
  • Delirium [Time frame: Within 7 days after surgery]
  • CVA / TIA [Time frame: Within 30 days after surgery]
  • Myocardial Ischemia [Time frame: During hospital stay, within 30 days after surgery]
  • Arrhythmia [Time frame: During hospital stay, within 30 days after surgery]
  • Atelectasis [Time frame: During hospital stay, within 30 days after surgery]
  • Pneumonia [Time frame: During hospital stay, within 30 days after surgery]
  • ARDS [Time frame: During hospital stay, within 30 days after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnancy.
  • Planned open abdominal surgery.
  • Renal Replacement Therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Israel · 1 center
  • Hadassah Medical Center — Jerusalem

Identifiers

NCT: NCT06685159 · 0303-23 HMO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗