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

NCT06685159 | Recruiting

• 1 other identifier: 0303-23 HMO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trendelenburg Position; Pneumoperitoneum

Outcome Measures

Primary Outcomes (11)

• 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

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

• Acute Kidney Injury

  According to the KDIGO acute renal injury stage

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

• 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

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

• Perioperatitve change in serum concentration of Cannabidiol

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

  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

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

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

• Perioperatitve change in TBW

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

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

• Perioperatitve change in ECW

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

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

• Perioperatitve change in serum pH

  As measured by arterial blood gas

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

• Perioperatitve change in serum BE

  Perioperatitve change in serum Base Excess (BE) As measured by arterial blood gas

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

• Perioperatitve change in serum lactate concentration

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

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

• Perioperatitve change in serum syndecan-1 concentration

  Measured by ELISA

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

Secondary Outcomes (7)

• Delirium

  Within 7 days after surgery

• CVA / TIA

  Within 30 days after surgery

• Myocardial Ischemia

  During hospital stay, within 30 days after surgery

• Arrhythmia

  During hospital stay, within 30 days after surgery

• Atelectasis

  During hospital stay, within 30 days after surgery

Interventions

Laparoscopic Surgery PROCEDURE

Laparoscopic surgery (with controlled pneumoperitoneum) in the Trendelenburg position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who undergo elective laparoscopic surgery in the Hadassah Ein-Kerem Medical Center

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Reuven Pizov: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Yerushalaim, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Reuven Pizov, MD

CONTACT

+9720506265542; pizovr@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesia Department Chair

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

IL (1)