Transnasal Endoscopy in Obese Patients Are Candidates for Bariatric Surgery

NCT03288259 | Unknown DMC

• 1 other identifier: 65003516.2.0000.5149
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Transnasal Endoscopy in Obese Patients are Candidates for Bariatric Surgery Introduction and Objectives: high digestive endoscopy (HDE) is an important tool in the preoperative period of bariatric surgery. Patients with excess weight have a higher risk of cardiorespiratory complications during this procedure, being that the transnasal endoscopy (TNE) with an endoscope-thin is a safe alternative, comfortable and great value for money. The TNE allows the study of the upper gastrointestinal tract without the need for sedation. The objective of this work was to evaluate the feasibility, tolerance and safety of TNE in obese patients are candidates for bariatric surgery. Methods: This was a prospective study with all patients with indication for surgery of obesity undergoing endoscopic transnasal preoperatively, between December 2016 and August 2018, at the Hospital of the Federal University of Minas Gerais. The variables evaluated were: age, gender, suitability of the exam, tolerance by the patient through the visual analogue scale, incidence of complications and need for sedation. Oxygen saturation, heart rate and systolic blood pressure were recorded. Conclusion: The transnasal endoscopy is a feasible alternative, well tolerated and safe the conventional endoscopy in evolution the preoperative bariatric surgery. The benefits of transnasal endoscopy in obese patients mainly consist in carrying out the procedure without sedation, which may provide reduction of risks, costs and waive the need for a companion. Key words: transnasal endoscopy - Obesity - endoscopy without sedation.

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

Transnasal endoscopy - Obesity - endoscopy without sedation

Outcome Measures

Primary Outcomes (1)

• Feasibility of the procedure

  The exam will be considered feasible if the appliance reaches the second duodenal portion and is performed retroflexão, allowing the visualization of all portions of the digestive system and the achievement of biopsies if necessary. All patients will complete a questionnaire 15 to 30 minutes after the transnasal endoscopy and will be released next to the house. All of this information and the results will be compared with the main data in the literature. Bivariate analyzes shall be calculated from the test "t" test for continuous variables and the chi-square test or Fisher exact test for categorical variables. Proportions will be reported by categorical data; and mean, median and standard deviation for continuous variables. P values less than 0.05 are considered statistically significant.

  15 minutes

Study Arms (1)

Obese patients

EXPERIMENTAL

Obese patients undergoing Local Anesthetics and Transnasal Endoscopy.

Procedure: transnasal endoscopy; Drug: Local Anesthetics,Topical

Interventions

transnasal endoscopy PROCEDURE

Transnasal endoscopy without sedation with ultra-thin endoscopes in patients who are candidates for bariatric surgery

Obese patients

Local Anesthetics,Topical DRUG

Will be carried out topical anesthesia of the pharynx with lidocaine spray (10%) 6 puffs and instillation of nasal vasoconstrictor 4 drops.

Obese patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A BMI greater than or equal to 40 Kg/m²
• A BMI greater or equal 35 Kg/m² associated with comorbidity (e.g., arterial hypertension, diabetes, dyslipidemia, sleep apnea)

You may not qualify if:

• Surgery, fractures or nasal malformations
• History of epistaxis
• Allergy to components of the topical anesthetic used prior to the examination
• Coagulation disorders or use of anticoagulants
• Pregnancy
• Psychiatric disorder important

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Alpha Institute of Gastroenterology - HC/UFMG Rua Alfredo Balena, 110 - 2. Cycling - Santa Efigênia.

Belo Horizonte, Minas Gerais, 30130100, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Amaury Xavier

CONTACT

55(31)34099248; amaury201@yahoo.com.br

Vitor Arantes, PhD

CONTACT

55(31)34099248; arantesvitor@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: September 20, 2017
• Study Start: December 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)