Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Emory University

Status: Completed

Conditions: Obesity; Gastrectomy

Treatments: Device: Esophagogastroduodenoscopy (EGD) calibration; Device: ViSiGi® 3D suction calibration device

Study type: Interventional

Funder types: Other

Identifiers

NCT03939819

IRB00108907

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

ViSiGi® 3D suction calibration device

Experimental group

Description:

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.

Treatment:

Device: ViSiGi® 3D suction calibration device

Esophagogastroduodenoscopy (EGD) calibration

Active Comparator group

Description:

Gastroscope, similar to The ViSiGi device, have suction, calibration, and leak testing capabilities.

Treatment:

Device: Esophagogastroduodenoscopy (EGD) calibration