An observational study in Pneumoperitoneum and Renal Injury, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Observational
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.
Renal NIRS monitoring will be performed in patients undergoing laparoscopic cholecystectomy surgery. Age, gender, BMI, ASA scores, hemogblin/hematocrit 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. .
Before the general anesthesia is performed, the renal tissues of the patients will be visualized by ultrasound, the skin-renal cortex distances will be measured, and suitable patients will be included in the study. Basal rSO2 values will be recorded by placing NIRS probes under the 10-11. intercostal space in the bilateral posterior lateral flank region.
134 studies on the registry are indexed under Pneumoperitoneum; 28 are open to participants now.
This study's planned enrollment of 58 is close to the median of 59 across 48 observational studies indexed under Pneumoperitoneum.
Browse Pneumoperitoneum studies →Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who undergoing elective laparoscopic cholecystectomi surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Renal perfusion will be evaluated with NIRS
Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test
Taking a blood test to evaluation N-GAL
Time frame: 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
Time frame: During laparoscopic cholecystectomy operation and within 24 hours postoperative
Plan to share: No
Start is estimated for Nov 2023; primary completion for Apr 2024, 4 months later.
Of 26 observational studies under Pneumoperitoneum, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Diskapi Yildirim Beyazit Education and Research Hospital