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

NCT06338423 | Completed

• 1 other identifier: JagiellonianU-08
• Study Type: interventional
• Target: 1,184
• Locations: 1 country
• Sites: 1

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

Conditions

Rhabdomyolysis; Acute Kidney Injury; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Concentration of myoglobin marker

  1 day

• Concentration of creatine kinase marker

  1 day

• Concentration of creatinine marker

  1 day

Study Arms (2)

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.

Device: vacuum mattress

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.

Other: Standard Mattress

Interventions

vacuum mattress DEVICE

vacuum mattresses used to better positioning of the patient

Vacuum Mattress Arm

Standard Mattress OTHER

Standard Mattress

Standard Mattress arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 which will be qualified for LSG due to obesity

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Mecical Collage

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

MeSH Terms

Conditions

Rhabdomyolysis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PD

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)