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.

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.

Study Overview

• Status: Completed
• Conditions: To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients
• Intervention / Treatment: Other: ACERTO protocol vs Traditional care

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • MT
    • Cuiaba, MT, Brazil, 78000000
      • ACERTO protocol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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

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Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ACERTO; Patients received 400 ml of a beverage containing water and 50 g of maltodextrin 6 hours before the operation. They received orally extra 200 ml of this beverage containing water and 25 g of maltodextrin 3 hours before the operation. Regarding the intravenous fluids, they received 1 to 1.5 liter of crystalloid fluids (ringer lactate) in the intraoperative. In the immediate postoperative they were programmed to receive 2 liters of crystalloid fluids (ringer lactate) and 1 to 2 liters in the first day of the postoperative period. The venous hydration was suspended as soon as they started to drink liquids. Prophylaxis of nausea and vomiting with dexamethasone 8 mg at the beginning of the anesthesia and ondansetron 4-8 mg after the surgery. In the postoperative period we utilized analgesics such as dipyrone and ketorolac and, if necessary, low doses of morphine and antiemetics like ondansetron.	Other: ACERTO 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.
Active Comparator: Traditional care; The analgesia in the postoperative period of the group control was performed with dipyrone, tramadol hydrochloride, and morphine. The prophylaxis of nausea and vomiting with dexamethasone 8 mg in the beginning of the anesthesia and the metoclopramide at the end of the surgery. During the anesthetic induction antibiotic prophylaxis (cefazolin 3 grams/day for 2 days) was administrated. The control group were submitted to the protocol of traditional fasting with at least 8 hours. Patients in this group received 1 to 2 liters of crystalloid fluid (ringer lactate) in the intraoperative, and they received 3 to 4 liters of crystalloid fluids (ringer lactate, saline 0.9% and/or dextrose 5%). In the immediate postoperative, 2 to 3 liters in the first day of postoperative and, finally, 1 to 2 liters in the second day of the postoperative.	Other: ACERTO 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACERTO protocol	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.	6 months

Collaborators and Investigators

• Sponsor: Cuiaba University
• Investigators: Principal Investigator: Gunther P Pimenta, MD, PhD, Cuiaba University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 12, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Insulin Resistance; Length of Stay; Obesity, Morbid; Protocols; Randomized Controlled Trial.; Gastroplasty; Acute-Phase Reaction
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Obesity; Insulin Resistance
• Other Study ID Numbers: 018/CEP-UNIC/2011.