Preoperative and Postoperative Endoscopic Alterations in Patients Submitted to Gastric Bypass Without a Ring

NCT03106207 | Completed DMC

• 1 other identifier: KaiserCDH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the high success rates of gastric bypass in the short and long terms, little is known about possible anatomopathological changes that can occur in these patients. The objective is to investigate preoperative and postoperative endoscopic changes in patients undergoing gastric bypass without a ring. Thirty obese patients from different regions of the country with the surgical indication for the Roux-en-Y gastric bypass will be studied prospectively. All patients will be submitted to upper gastric endoscopy (UGE) two, six and 12 months after the surgical procedure at the Kaiser Clinic. This study will identify whether there are endoscopic changes within one year after the surgery and what they are. Changes, if they exist, will be correlated with clinical data, in order to make an accurate prognosis of the patient, thereby contributing to the outcomes of future patients submitted to this type of procedure.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight loss

  weight in kg

  Before surgery and at 2, 6, 12 and 24 months

Secondary Outcomes (7)

• The mucosal lesions of the distal esophageal body by Los Angeles Classification

  Before surgery and at 2, 6, 12 and 24 months

• Gastric pouch Anteroposterior diameter (cm)

  Before surgery and at 2, 6, 12 and 24 months

• Length of lesser curvature (cm)

  Before surgery and at 2, 6, 12 and 24 months

• Gastrojejunal anastomosis (mm)

  Before surgery and at 2, 6, 12 and 24 months

• The mucosal changes in jejunal loops will be studied for any lesion like marginal ulcers

  Before surgery and at 2, 6, 12 and 24 months

Study Arms (1)

Upper gastric endoscopy (UGE)

OTHER

Patients will be submitted to a UGE before the gastric bypass surgery without a ring and at two, six and 12 months after the surgical procedure .

Procedure: Upper gastric endoscopy (UGE)

Interventions

Upper gastric endoscopy (UGE) PROCEDURE

UGE will be performed before the gastric bypass surgery and post-surgery at two, six and 12 months of clinical visit.

Upper gastric endoscopy (UGE)

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years and younger than 65 years of age;
• Patients with indication for gastric bypass without ring;
• Patient attending regular appointments in the Gastroenterology Service.

You may not qualify if:

• Patients younger than 18 and over 65 years of age;
• Patients who have no indication of gastric bypass without a ring;
• Pregnant women (a BHCG test will be required from all women of childbearing age).

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

Kaiser Clinic and Day Hospital

São José do Rio Preto, São Paulo, 15015-110, Brazil

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Luiz Gustavo de Quadros, MD

  Kaiser Clinica and Day Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: April 10, 2017
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 5, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

BR (1)