Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Gastrectomy
• Intervention / Treatment: Device: ViSiGi® 3D suction calibration device; Device: Esophagogastroduodenoscopy (EGD) calibration

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 Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital Midtown

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

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)
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	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.	3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Elizabeth Hechenbleikner, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 2, 2022

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: bariatric surgery; laparoscopic sleeve gastrectomy; weight loss surgery; suction calibration system
• Other Study ID Numbers: IRB00108907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team does not plan to make the data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No