Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference

Conditions
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Gastrectomy, Obesity

Intervention / Treatment
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* Device: ViSiGi® 3D suction calibration device
* Device: Esophagogastroduodenoscopy (EGD) calibration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older agreed with a surgeon that laparoscopic sleeve gastrectomy (LSG) is the best choice Exclusion Criteria: Had prior gastric surgery or bariatric surgery (including prior adjustable gastric band and/or sleeve gastrectomy) Concomitant hiatal surgery Paraesophageal hernia at time of surgery Any subject with prescribed immunosuppressive drugs. In the opinion of investigator, subject is not eligible to participate in the study. If patient is a female and becomes pregnant at any time during the study duration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ViSiGi® 3D suction calibration device<br>The ViSiGi® 3D is the first calibration system specifically intended for use during sleeve gastrectomy.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. Advantages of ViSiGi® 3D device include simplification of sleeve calibration in addition to suctioning the stomach and performing leak tests all with one device making operative steps simpler for both the anesthesiology team and surgeons. Since it is single patient use it does not require reprocessing. | Device: ViSiGi® 3D suction calibration device<br>* 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.<br>|
| Active Comparator: Esophagogastroduodenoscopy (EGD) calibration<br>Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. | Device: Esophagogastroduodenoscopy (EGD) calibration<br>* Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Staple Load Firings | Staple usage will be recorded during the weight loss surgery procedure. | During sleeve gastrectomy (up to 5 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Duration (Time) | Surgery start and completion time will be recorded, and operative duration will be calculated | During sleeve gastrectomy (up to 5 hours) | 
| Intra-operative Cost for Patients | Cost data (administrative data) will be retrieved from internal database | During sleeve gastrectomy (up to 5 hours) | 
| Change in GERD Symptom Severity | 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. 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 | 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) | 
| Change in Body Weight | Mean % total body weight loss will be calculated | 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss surgery, laparoscopic sleeve gastrectomy, suction calibration system, bariatric surgery