This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during "laparoscopic sleeve gastrectomy" (LSG).
There are multiple choices for a surgeon and their patient when it comes to weight loss surgery. One of those options is a procedure called a "laparoscopic sleeve gastrectomy" (LSG). In this procedure the majority of the patient's stomach is removed leaving behind a stapled "sleeve" about the same size as the patient's esophagus. During this procedure there are three main devices that surgeon inserts through the mouth and in to the stomach to calibrate the size of the "sleeve". They can use a standard weighted bougie, an endoscope, or a suction calibration device. This study aims to compare the difference in staple usage and post-operative GERD (heartburn) between patients that had an endoscope used versus patients that had a suction calibration system used on them during LSG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
Emory University Hospital Midtown
Atlanta, Georgia, United States
Number of Staple Load Firings
Staple usage will be recorded during the weight loss surgery procedure.
Time frame: During sleeve gastrectomy (up to 5 hours)
Operative Duration (Time)
Surgery start and completion time will be recorded, and operative duration will be calculated
Time frame: During sleeve gastrectomy (up to 5 hours)
Intra-operative Cost for Patients
Cost data (administrative data) will be retrieved from internal database
Time frame: During sleeve gastrectomy (up to 5 hours)
GERD Symptom Severity Score
GERD-HRQL questionnaire will be administered pre-operatively and post-operatively. The instrument contains a total of 10 scaled items which are scored, and a patient-reported global satisfaction assessment which is not added to the total GERD-HRQL score. Higher score correlates with worse outcome. Scale: No symptoms = 0; Symptoms noticeable, but not bothersome = 1; Symptoms noticeable and bothersome, but not every day = 2; Symptoms bothersome every day = 3; Symptoms affect daily activities = 4; Symptoms are incapacitating, unable to do daily activities = 5
Time frame: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Body Weight
Total body weight was calculated in Kg.
Time frame: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
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