Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vacuum Mattress Arm | Experimental | 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. |
|
| Standard Mattress arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vacuum mattress | Device | vacuum mattresses used to better positioning of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidance of Rhabdomyolisis(RML) And/OR Acute Kidnay Injury (AKI) | The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which requireds additional treatment. | 30 day |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of myoglobin marker | 1 day | |
| Concentration of creatine kinase marker | 1 day | |
| Concentration of creatinine marker |
Not provided
Inclusion Criteria:
Patients aged ≥18 which will be qualified for LSG due to obesity
Exclusion Criteria:
Patients with preoperative chronic renal failure will be excluded from the study. Other exclusion criteria are perioperative complications which require postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERAbSERABS ) Protocol < 85%.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Mecical Collage | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Mattress | Other | Standard Mattress |
|
| 1 day |
| ID | Term |
|---|---|
| D012206 | Rhabdomyolysis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided