Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939819
• Other study ID #: IRB00108907
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: February 2, 2022

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrectomy
• Obesity

Intervention

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.
• Esophagogastroduodenoscopy (EGD) calibration
Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Staple Load Firings	Staple usage will be recorded during the weight loss surgery procedure.	During sleeve gastrectomy (up to 5 hours)
Secondary	Operative Duration (Time)	Surgery start and completion time will be recorded, and operative duration will be calculated	During sleeve gastrectomy (up to 5 hours)
Secondary	Intra-operative Cost for Patients	Cost data (administrative data) will be retrieved from internal database	During sleeve gastrectomy (up to 5 hours)
Secondary	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)
Secondary	Body Weight	Total body weight was calculated in Kg.	3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)