An interventional study of Carbon dioxide and Ambient air in Dilatation of Anastomosis, Bypass Complication and Obesity, sponsored by Kaiser Clinic and Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Kaiser Clinic and Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Argon fulguration will be performed using CO2 for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
Drug: Carbon dioxide · Drug: Argon fulguration
Argon fulguration will be performed using ambient air for insufflation. After using a disposable endoscopic catheter, argon plasma (Argon 2) (MAE, Ribeirão Preto, Brazil) will be applied in a 1-cm band around the entire circumference of the gastrojejunal anastomosis at an intensity of 90 W and a flow rate of 2 L/min.
Drug: Ambient air · Drug: Argon fulguration
Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
Also known as: Carbon dioxide insufflation
Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
Also known as: Ambient air insuflattion
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).
Also known as: Argon
Change in Pain Visual Analogue Scale
A visual scale to assess self-reported pain going from 0 to 10.
Time frame: Before surgery, and after eight weeks of the first endoscopic session. The outcome will be the substraction of the initial value and the final value of pain.
Change in diameter of the gastrojejunal anastomosis
Analysis and measurement in millimeters of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA).
Time frame: Before surgery, and after eight weeks of the first endoscopic session.
Weight reduction
The final weight measured in kilograms after eight weeks of the initial surgery will be subtracted from the weight at the start of the trial
Time frame: Before surgery, and after eight weeks of the first endoscopic session.
Plan to share: Undecided
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Kaiser Clinic and Hospital