Preoperative and Postoperative Endoscopic Alterations in Patients Submitted to Gastric Bypass Without a Ring
Condition: Obesity
Study type: Interventional

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.
    

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.
    

Intervention name(s): Upper gastric endoscopy (UGE)
Intervention type(s): Procedure
Intervention description(s): UGE will be performed before the gastric bypass surgery and post-surgery at two, six and 12 months of clinical visit.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment