Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

NCT ID: NCT06000098

Last Updated: 2024-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2023-10-16

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Acute Kidney Injury Hemodynamic Instability

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

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

Restrictive fluid therapy

Intervention Type OTHER

0,5 ml/hour fluid administration during prostatic anastomosis.

After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).

Interventions

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Restrictive fluid therapy

0,5 ml/hour fluid administration during prostatic anastomosis.

After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).

Intervention Type OTHER

Other Intervention Names

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Trendelenburg position.

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fevzi Toraman, M.D.

Role: STUDY_DIRECTOR

Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

Locations

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Acibadem Altunizade Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.

Reference Type BACKGROUND
PMID: 26844486 (View on PubMed)

Sudfeld S, Leyh-Bannurah SR, Budaus L, Graefen M, Reese PC, von Breunig F, Reuter DA, Saugel B. Impact of perioperative administration of 6 % hydroxyethyl starch 130/0.4 on serum cystatin C-derived renal function after radical prostatectomy: a single-centre retrospective study. BMC Anesthesiol. 2016 Aug 30;16(1):69. doi: 10.1186/s12871-016-0236-8.

Reference Type BACKGROUND
PMID: 27576693 (View on PubMed)

Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.

Reference Type BACKGROUND
PMID: 21233502 (View on PubMed)

Emir NS, Akyol D, Sabaz MS, Karadag S. Robotic assited perineal prostatectomy (RAPP) as a new era for anesthesiology: It's effects on hemodynamic parameters and respiratory mechanics. J Robot Surg. 2023 Jun;17(3):933-940. doi: 10.1007/s11701-022-01482-x. Epub 2022 Nov 16.

Reference Type RESULT
PMID: 36383279 (View on PubMed)

Valdivieso RF, Hueber PA, Zorn KC. Robot assisted radical prostatectomy: how I do it. Part I: Patient preparation and positioning. Can J Urol. 2013 Oct;20(5):6957-61.

Reference Type RESULT
PMID: 24128839 (View on PubMed)

Karaveli A, Kavakli AS, Cakin O, Aykal G, Yildiz A, Ates M. Comparison of plasma neutrophil gelatinase-associated lipocalin (NGAL) levels after robot-assisted laparoscopic and retropubic radical prostatectomy: an observational study. Braz J Anesthesiol. 2022 Jan-Feb;72(1):21-28. doi: 10.1016/j.bjane.2021.03.003. Epub 2021 Apr 2.

Reference Type RESULT
PMID: 33819496 (View on PubMed)

Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.

Reference Type RESULT
PMID: 33020097 (View on PubMed)

Other Identifiers

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ATADEK 2021-01/2

Identifier Type: -

Identifier Source: org_study_id

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