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

April 4, 2017 updated by: Kaiser Clinic and Hospital

Prospective Single-center Study to Evaluate Preoperative and Postoperative Endoscopic Alterations in Patients Submitted to Gastric Bypass Without a Ring.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

People with severe or morbid obesity often fail to lose weight in the long term. Gastric bypass is considered the gold standard in the surgical treatment of obesity. 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. UGE has been used on a wide scale in complementary evaluations of patients submitted to bariatric surgery. However, there is still no consensus on the use of imaging tests such as UGE in the follow-up of these patients after surgery. Considering the importance of gastric bypass in the treatment of obesity, knowledge about possible preoperative and postoperative GI alterations identified by endoscopy in these patients may contribute to the establishment of correlations with symptomatology and with the success rate of this technique during follow-ups of up to 12 months.

Organization and infrastructure: This study is organized based on a single location: the Kaiser Clinic and Day Hospital. This center is renowned for the treatment of diseases in the areas of Gastroenterology, Proctology and General Surgery.

Objectives:

General: Demographic, clinical, nutritional, operative and endoscopic data will be assessed.

Specific: The objective of this research will be to investigate preoperative and postoperative endoscopic changes in patients undergoing gastric bypass without a ring.

Patients and Methods: Thirty obese patients from different regions of the country with surgical indication for the Roux-en-Y gastric bypass will be studied prospectively. Patients who meet the inclusion criteria will be invited to participate and, on agreeing, they will sign Informed Consent Forms. The procedures will be performed only after patients give their written consent.

Clinical evaluation of the patients Clinical history: Patients will be questioned about the frequency and intensity of their symptoms. Commonly used medications will be noted as well as drugs used for symptomatic relief (number of tablets). Any urgent/emergency events (such as emergency room visits and/or hospital admission) will be investigated. Other clinical events will also be recorded.

Physical examination:A physical examination (general and gastroenterological) will be performed routinely in all patients participating in this study.

Procedures in the pre- and post-procedure phases: Patients will be submitted to a UGE before the gastric bypass surgery without a ring. All changes related to the esophageal body, distal esophagus and stomach will be analyzed. Biopsies will be performed of the distal esophagus (two fragments 4 cm above the esophagogastric transition), gastric body (anterior and posterior walls), incisura angularis and gastric antrum (large and small pre-pyloric curvature). Furthermore, biopsies will be performed of any lesions detected in the esophagus or stomach.

All patients will be submitted to UGE two, six and 12 months after the surgical procedure. The following will be performed in postoperative endoscopies:

1- The mucosa of the esophageal body will be studied, biopsies of the distal esophagus (two fragments) and small curvature (two fragments) will be performed and the gastric pouch width and anteroposterior diameter and length of the small curvature will be evaluated; 2 - the shape of the gastrojejunal anastomosis will be evaluated and the maximum diameter will be measured and 3 - the jejunal loops will be studied in relation to mucosal changes and afferent loop size and angulation.

All exams will be performed at the Kaiser Clinic after patients have fasted for at least eight hours and signed an informed consent form for the UGE. With the patient in left lateral decubitus position, 10% xylocaine spray will be instilled followed by 50 mcg fentanyl EV and 5 mg midazolam EV. After sedation, an Olympus CV 180 endoscope (Olympus, Tokyo, Japan) will be introduced orally. The images obtained will be transferred to a Olympus EVIS EXERA II processor connected to a computer unit with the ZScan 5 program (Zscan Software Ltda, Goiânia, Brazil). When the patient regains his level of consciousness, he will be released in the company of a responsible adult.

Postoperative clinical evaluation: After hospital discharge, all patients should return for outpatient follow-ups including a clinical evaluation and endoscopy exams.

Clinical visits will be scheduled as follows:

Visit 1 - 2 months; Visit 2 - 6 months; Visit 3 - 12 months

Clinical complications / adverse events / clinical outcomes: For all patients, any possible clinical complication will be promptly checked by the principal investigator.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Jose do Rio Preto, SP, Brazil, 15015-110
        • Kaiser Clinic and Day Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Upper gastric endoscopy (UGE)
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)
UGE will be performed before the gastric bypass surgery and post-surgery at two, six and 12 months of clinical visit.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Before surgery and at 2, 6, 12 and 24 months
weight in kg
Before surgery and at 2, 6, 12 and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The mucosal lesions of the distal esophageal body by Los Angeles Classification
Time Frame: Before surgery and at 2, 6, 12 and 24 months
The biopsies of the distal esophagus (two fragments) will be performed to study the mucosa through upper gastric endoscopy.
Before surgery and at 2, 6, 12 and 24 months
Gastric pouch Anteroposterior diameter (cm)
Time Frame: Before surgery and at 2, 6, 12 and 24 months
All measurements will be evaluated through UGE
Before surgery and at 2, 6, 12 and 24 months
Length of lesser curvature (cm)
Time Frame: Before surgery and at 2, 6, 12 and 24 months
All measurements will be evaluated through UGE
Before surgery and at 2, 6, 12 and 24 months
Gastrojejunal anastomosis (mm)
Time Frame: Before surgery and at 2, 6, 12 and 24 months
All measurements will be evaluated through UGE
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
Time Frame: Before surgery and at 2, 6, 12 and 24 months
The mucosal changes will be evaluated through UGE
Before surgery and at 2, 6, 12 and 24 months
Quality of Afferent loop size as adequate or not.
Time Frame: Before surgery and at 2, 6, 12 and 24 months
Afferent loop size will be evaluated through UGE
Before surgery and at 2, 6, 12 and 24 months
Afferent loop angulation
Time Frame: Before surgery and at 2, 6, 12 and 24 months
Evaluated through UGE: the Y (two bowel) afferent bowel or efferent bowel
Before surgery and at 2, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiser Clinic and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KaiserCDH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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