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

NCT ID: NCT02113995

Last Updated: 2014-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-10-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ACERTO protocol vs Traditional care

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

ACERTO protocol vs Traditional care

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cuiaba University

OTHER

Sponsor Role: lead

Responsible Party

Gunther Peres Pimenta

MD PhD Gunther Peres Pimenta

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunther P Pimenta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cuiaba University

Locations

ACERTO protocol

Cuiabá, Mato Grosso, Brazil

Countries

Brazil

Other Identifiers

018/CEP-UNIC/2011.

Identifier Type: -

Identifier Source: org_study_id