PneumoperitoneumNCT06116383
Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery
An observational study of Pneumoperitoneum and Renal Injury, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumoperitoneum, Renal Injury
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergoing elective laparoscopic cholecystectomi surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
Ankara, 06450
About this study
Official title: Evaluation of Renal Perfusion With NIRS in Adult Patients Undergoing Laparoscopic Cholecystectomy.
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.
Read the detailed description
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.
- Conditions
- Pneumoperitoneum, Renal Injury
- Being tested
- NIRS
- Keywords
- laparoscopy, NIRS, N-GAL
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Renal perfusion will be evaluated with NIRS
| Study group | Role | What they receive |
|---|---|---|
| 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. . Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test
Taking a blood test to evaluation N-GAL
Measured: 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
Measured: During laparoscopic cholecystectomy operation and within 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start10 Nov 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Savaş Altınsoy, MD, Study chair, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116383
- Sponsor's protocol ID
- NIRS
- Status last verified
- Nov 2023
- First submitted
- 28 Sep 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32651617
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Renal Perfusion With NIRS in Adult Patients Undergoing Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT06116383
- Acronym / sponsor ID
- NIRS
- Conditions
- Pneumoperitoneum, Renal Injury
- Keywords
- laparoscopy, NIRS, N-GAL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing laparoscopic cholecystectomy. | – | Device: NIRSBasal 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. . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergoing elective laparoscopic cholecystectomi surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSRenal perfusion will be evaluated with NIRS | Device | Patients undergoing laparoscopic cholecystectomy. |
Primary outcome
Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test
Time frame: During laparoscopic cholecystectomy operation and within 24 hours postoperative
Taking a blood test to evaluation N-GAL
Evaluation of renal damage caused by pneumoperitoneum with urea/creatinin by blood test
Time frame: During laparoscopic cholecystectomy operation and within 24 hours postoperative
Taking a blood test to evaluation urea/creatinine values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 32651617Caliskan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savaş Altınsoy, MD study chair
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum and Renal Injury, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Savaş Altınsoy, MD (0905332257104, savasaltinsoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of renal damage caused by pneumoperitoneum with N-GAL by blood test (time frame: During laparoscopic cholecystectomy operation and within 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06116383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.