Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure
NCT ID: NCT06338423
Last Updated: 2024-03-29
Study Results
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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COMPLETED
NA
1184 participants
INTERVENTIONAL
2015-01-01
2022-12-31
Brief Summary
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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
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Vacuum Mattress Arm
Patients will be operated in a beach chair position. The patient will ley on vacuum mattresses during the surgery.
Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery.
vacuum mattress
vacuum mattresses used to better positioning of the patient
Standard Mattress arm
Patients will be operated in a beach chair position. The patient will ley on standard mattresses during the surgery.
Patients' demographics, and perioperative data including age, gender, body mass index (BMI), smoking, ASA score, incidence of co-morbidities, compliance with ERABS protocol, amount of intraoperative blood loss, intraoperative complications, and surgery duration will be collected. Blood samples will be collected on first postoperative day to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI and other complications were monitored for 30 days after surgery.
Standard Mattress
Standard Mattress
Interventions
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vacuum mattress
vacuum mattresses used to better positioning of the patient
Standard Mattress
Standard Mattress
Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Mateusz Wierdak
MD PD
Locations
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Jagiellonian University Mecical Collage
Krakow, Lesser Poland Voivodeship, Poland
Countries
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Other Identifiers
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JagiellonianU-08
Identifier Type: -
Identifier Source: org_study_id