Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure

Acute Kidney Injury Clinical Trial

Official title:

Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06338423
• Other study ID #: JagiellonianU-08
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Bariatric Surgery Candidate
• Renal Insufficiency
• Rhabdomyolysis

Intervention

Device:
• vacuum mattress
vacuum mattresses used to better positioning of the patient

Other:
• Standard Mattress
Standard Mattress

Locations

Country	Name	City	State
Poland	Jagiellonian University Mecical Collage	Kraków	Malopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Concentration of myoglobin marker		1 day
Secondary	Concentration of creatine kinase marker		1 day
Secondary	Concentration of creatinine marker		1 day