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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02113995

Enrollment

Registered

2014-04-15

Start date

2012-04-30

Completion date

2012-10-31

Last updated

2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Obesity, Morbid, Insulin Resistance, Acute-Phase Reaction, Gastroplasty, Length of Stay, Protocols, Randomized Controlled Trial.

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.

Interventions

OTHERACERTO protocol vs Traditional care

Three sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026