Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.

Not Applicable

Completed

• Conditions: To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients

• Registration Number: NCT02113995
• Lead Sponsor: Cuiaba University

Brief Summary

Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.

Detailed Description

Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2014-04
• Study First Submitted: 2014-04-12
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

We included patients who are between 18 and 45 years of age, from both sexes, with an initial BMI (Body Mass Index) which is equal to or greater than 40 kg/m2, candidates for the sleeve surgery procedure through laparoscopy.

Exclusion Criteria

We excluded the patients who didn't follow the fasting protocol and also those whose laboratory exams were lost.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ACERTO protocol	6 months	To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.

Trial Locations

Locations (1)

ACERTO protocol; 🇧🇷 Cuiaba, MT, Brazil