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Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

A

Acibadem University

Status

Completed

Conditions

Hemodynamic Instability
Acute Kidney Injury

Treatments

Other: Restrictive fluid therapy

Study type

Observational

Funder types

Other

Identifiers

NCT06000098
ATADEK 2021-01/2

Details and patient eligibility

About

Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. However, the possible side effects of the deep Trendelenburg's position and the fluid restriction on the cardiovascular and renal systems during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Long console time may contribute to the development of acute kidney injury (AKI) by prolonging the Trendelenburg time and the fluid-restricted time. In this study, investigators aimed to demonstrate the effect of console time on the development of AKI. Investigators also aimed to determine the hemodynamic risk factors that cause the development of AKI in patients monitored with the pressure Recording Analytical Method (PRAM).

Full description

Although open surgery has been used for a long time in the treatment of prostate diseases, robotic-assisted laparoscopic prostatectomy (RALP) has become more common in the last 20 years. The excellence in results has made the use of the robot the gold standard in prostate surgery. However, the presence of two critical factors during RALP surgery still bothers clinicians. The first of these is severe fluid restriction and the other is the deep Trendelenburg position and pneumoperitoneum. The prolongation of the robotic console time also causes the prolongation of fluid restriction and Trendelenburg time. This combination may cause significant pathophysiological changes in both the renal and cardiac systems and may lead to postoperative acute renal injury (AKI). AKI is a serious clinical complication with increasing incidence and is associated with adverse short-term and long-term outcomes worldwide, resulting in a large healthcare burden. Intraoperative advanced monitoring techniques can contribute to the prevention of renal damage that may occur by providing early recognition of these pathophysiological changes occurring in the renal and cardiac systems.

The aim of our study was to determine the effect of console duration on the incidence of AKI after RALP which was managed using intraoperative advanced monitoring techniques (pressure recording analytical method-PRAM). In addition, this study aimed to evaluate the ability of changes in hemodynamic parameters to predict the development of AKI in RALP patients who underwent restrictive fluid therapy.

Enrollment

42 patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with American Society Of Anesthesiology physical status 1-3
  • Underwent Robotic-assisted laparoscopic prostatectomy
  • Underwent restrictive fluid therapy during the console period

Exclusion criteria

  • Under 18 years of age
  • Arrhythmia (atrial fibrillation, frequent premature beat)
  • History of myocardial infarction in the last 3 months
  • Heart failure
  • Severe pre-existing lung disease
  • Severe valvular heart disease
  • Chronic renal disease on dialysis,

Trial design

42 participants in 1 patient group

Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.
Description:
Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position with restrictive fluid therapy
Treatment:
Other: Restrictive fluid therapy

Trial contacts and locations

1

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Central trial contact

Zeynep T Sarikaya, M.D.; Serap Aktas Yildirim, MD

Data sourced from clinicaltrials.gov

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