Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ViSiGi® 3D suction calibration device 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
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.
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| Active Comparator: Esophagogastroduodenoscopy (EGD) calibration Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities. |
Device: Esophagogastroduodenoscopy (EGD) calibration
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
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Outcome Measures
Primary Outcome Measures
- Number of staple load firings [During sleeve gastrectomy (up to 5 hours)]
Staple usage will be recorded
Secondary Outcome Measures
- Operative duration (time) [During sleeve gastrectomy (up to 5 hours)]
Surgery start and completion time will be recorded, and operative duration will be calculated
- Intra-operative cost for patients [During sleeve gastrectomy (up to 5 hours)]
Cost data (administrative data) will be retrieved from internal database
- Change in GERD symptom severity [1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)]
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
- Change in body weight [1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)]
Mean % total body weight loss will be calculated
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
Investigators
- Principal Investigator: Elizabeth Hechenbleikner, MD, Emory University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00108907