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NCT Number: NCT06685159

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

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.

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Key information

Conditions

Trendelenburg Position Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Center

Jerusalem, Yerushalaim, Israel

Location status: Recruiting

Location contact

Adir Ben-Nahum, M.D.

CONTACT

[email protected]

+972504677005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic surgery

Procedure

Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position

Primary outcomes

  1. Perioperative change in urine NGAL

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    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

  2. Acute Kidney Injury

    Time frame: 2 hours after completion of surgery; 1 day after the procedure; 3 days after the procedure.

    According to the KDIGO acute renal injury stage

  3. Perioperative change in serum NGAL

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    Measurement of the concentration of neutrophil gelatinase-associated lipocalin (as an early marker of kidney injury) in a blood sample

  4. 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

    Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a blood sample

  5. 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

    Measurement of the concentration of cannabidiol (as an early marker of kidney injury) in a urine sample taken from a Foley catheter

  6. Perioperatitve change in TBW

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    Perioperative change in the bioimpedence-based measurement of Total Body Water (TBW)

  7. Perioperatitve change in ECW

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    Perioperative change in the bioimpedence-based measurement of Extracellular Water (ECW)

  8. Perioperatitve change in serum pH

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    As measured by arterial blood gas

  9. 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 Base Excess (BE) As measured by arterial blood gas

  10. Perioperatitve change in serum lactate concentration

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    Perioperatitve change in serum lactate concentration as measured by arterial blood gas

  11. Perioperatitve change in serum syndecan-1 concentration

    Time frame: Baseline (after anesthesia induction but before beginning of surgery) and 2h hours after completion of surgery

    Measured by ELISA

Secondary outcomes

  1. Delirium

    Time frame: Within 7 days after surgery

    As assessed by CAM-ICU

  2. CVA / TIA

    Time frame: Within 30 days after surgery

    New diagnosis of cerebrovascular accident or transient ischemic attack

  3. Myocardial Ischemia

    Time frame: During hospital stay, within 30 days after surgery

    New myocardial ischemia, as diagnosed by ecg or serum troponin

  4. Arrhythmia

    Time frame: During hospital stay, within 30 days after surgery

    New clinically significant arrhythmia

  5. Atelectasis

    Time frame: During hospital stay, within 30 days after surgery

    New atelectasis

  6. Pneumonia

    Time frame: During hospital stay, within 30 days after surgery

    According to CDC criteria

  7. ARDS

    Time frame: During hospital stay, within 30 days after surgery

    New Acute Respiratory Distress Syndrome (ARDS) according to Berlin criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Reuven Pizov, MD

CONTACT

[email protected]

+9720506265542

Sponsors and collaborators

Lead sponsor

Reuven Pizov

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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