Carbon Dioxide Versus Air Insufflation for the Application of Argon Plasma to Reduce the Gastrojejunal Anastomosis
Condition: Dilatation of Anastomosis; Bypass Complication; Obesity
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      The objective of this randomized clinical trial is to compare pain levels during and after
      insufflation with carbon dioxide or in subjects that will undergo endoscopic fulguration with
      argon to reduce the diameter of the gastrojejunal anastomosis. The investigators hypothesize
      that carbon dioxide will be superior in causing less pain and leading to less discomfort.
    

Detailed description: 
      Laparoscopic gastric bypass surgery is one of the strategies oriented towards weight
      reduction in obese patients. Although in the short term it has a high degree of success,
      weight regain is common in the long term, in part due to the dilatation of the anastomosis
      that allows food to pass without barriers and hinders the purpose of bypass surgery.
      Fulguration with argon is an endoscopic technique that reduces the diameter of the
      anastomosis, offering resistance to food passage and improving patient outcomes.

      Although carbon dioxide is the current standard for laparoscopic surgery, its use for
      fulguration with argon as compared to ambient air has not been investigated in the setting of
      the stenosis of a dilated anastomosis following gastric bypass surgery. stenosis. Therefore,
      to investigate pain during and after this procedure, investigators will conduct a randomized
      clinical trial comparing carbon dioxide and ambient air.

      The secondary aims will be to measure the diameter of the gastrojejunal anastomosis during
      three endoscopic sessions and in a final control examination eight weeks after the third
      session; to determine whether the patient loses weight or not by the final control objective
      after three sessions of endoscopic fulguration with argon; to analyze if the method employed
      is able to reduce body weight to the minimum weight achieved after bariatric surgery;and to
      investigate whether there is a correlation between the percentage reduction in anastomotic
      diameter and the percentage loss of regained weight.
    

Intervention name(s): Carbon dioxide; Ambient air; Argon fulguration
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.; Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.; The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).
Other intervention name(s): Carbon dioxide insufflation; Ambient air insuflattion; Argon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment