Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery

NCT06116383 | Unknown

• 1 other identifier: NIRS
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to show the renal damage caused by increased intra-abdominal pressure in laparoscopic surgeries and to investigate whether its reflection on NIRS would be clinically effective.The main question it aims to answer are: Does pneumoperitoneum cause renal damage? NRS monitoring will be performed in patients undergoing laparoscopic surgery. Preoperative and postoperative blood tests will be performed at certain hours. N-GAL, urea and creatinine values will be recorded.

Conditions

Pneumoperitoneum; Renal Injury

Keywords

laparoscopy; NIRS; N-GAL

Outcome Measures

Primary Outcomes (2)

• Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test

  Taking a blood test to evaluation N-GAL

  During laparoscopic cholecystectomy operation and within 24 hours postoperative

• Evaluation of renal damage caused by pneumoperitoneum with urea/creatinin by blood test

  Taking a blood test to evaluation urea/creatinine values

  During laparoscopic cholecystectomy operation and within 24 hours postoperative

Study Arms (1)

Patients undergoing laparoscopic cholecystectomy.

Basal rSO2 values will be recorded by placing NIRS probes under the 10-11th intercostal space in the bilateral posterior lateral flank region. Age, gender, BMI, ASA scores, Hb/Htc values, intraoperative hemodynamic parameters, NIRS values, N-GAL (preoperative, 2nd hour and 24th hour), urea/creatinine (preoperative, postoperative 24th hour) values of the patients will be recorded. .

Device: NIRS

Interventions

NIRS DEVICE

Renal perfusion will be evaluated with NIRS

Patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who undergoing elective laparoscopic cholecystectomi surgery

You may qualify if:

• Patients who undergoing elective laparoscopic cholecystectomi surgery lasting longer than 60 minutes
• BMI:18-25
• skin-renal cortex distance measured less than 4 cm on ultrasound
• ASA I-III

You may not qualify if:

• patient who did not give consent
• patient who had renal operation before,
• infection, abscess, catheter in the perirenal region
• hemodynamically unstable patients,
• patients with renal pathology and abnormal kidney function tests,
• emergency cases

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital

Ankara, 06450, Turkey (Türkiye)

Location

Related Publications (1)

• Caliskan E, Sanal Bas S, Onay M, Kilic Y, Kayhan Erdogan G, Tokar B. Evaluation of renal oxygenization in laparoscopic pediatric surgery by near infrared spectroscopy. Pediatr Surg Int. 2020 Sep;36(9):1077-1086. doi: 10.1007/s00383-020-04709-w. Epub 2020 Jul 10.

  PMID: 32651617 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Savaş Altınsoy, MD

  Ankara Etlik City Hospital

  STUDY CHAIR

Central Study Contacts

Savaş Altınsoy, MD

CONTACT

0905332257104; savasaltinsoy@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: November 3, 2023
• Study Start: November 10, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)