Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338423
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-24
Brief Title:
Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure
Sponsor:
Jagiellonian University
Organization:
Jagiellonian University
Study Overview
Official Title:
Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy LSG in the reduction of levels of rhabdomyolysis markers myoglobin creatine kinase creatinine and incidence of RML and AKI in the postoperative period
Method Patients
A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital Krakow Poland It is designed as a single-center prospective trial with two intervention arms During the study we specified 3 periods
January 2015 - December 2016 - only standard mattresses were used
January 2017 - December 2019 - both types of mattresses were used
January 2020 - December 2022 - only vacuum mattresses were used
Participants Patients aged 18 were qualified for LSG due to obesity and divided The first group Vacuum Mattress group are those laid on vacuum mattresses during the surgery The control group consisted of patients for whom a standard operating mattress was used during the surgery Patients with preoperative chronic renal failure were excluded from the study Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery ERABS Protocol 85
Procedures and perioperative care All patients underwent LSG Patients were operated in the beach chair position In the study group the patient was laid on vacuum mattresses during the surgery In the case of control group patients a standard operating mattress was used during the surgery Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center Blood samples were collected on the first postoperative to measure RML markers myoglobin creatine kinase creatinine Symptoms of RML AKI and other complications were monitored for 30 days after surgery
End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment
Secondary endpoints is the concentrations of RML markers myoglobin creatine kinase creatinine on the first postoperative day
Method Patients
A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital Krakow Poland It is designed as a single-center prospective trial with two intervention arms During the study we specified 3 periods
January 2015 - December 2016 - only standard mattresses were used
January 2017 - December 2019 - both types of mattresses were used
January 2020 - December 2022 - only vacuum mattresses were used
Participants Patients aged 18 were qualified for LSG due to obesity and divided The first group Vacuum Mattress group are those laid on vacuum mattresses during the surgery The control group consisted of patients for whom a standard operating mattress was used during the surgery Patients with preoperative chronic renal failure were excluded from the study Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery ERABS Protocol 85
Procedures and perioperative care All patients underwent LSG Patients were operated in the beach chair position In the study group the patient was laid on vacuum mattresses during the surgery In the case of control group patients a standard operating mattress was used during the surgery Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center Blood samples were collected on the first postoperative to measure RML markers myoglobin creatine kinase creatinine Symptoms of RML AKI and other complications were monitored for 30 days after surgery
End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment
Secondary endpoints is the concentrations of RML markers myoglobin creatine kinase creatinine on the first postoperative day
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None