Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Obesity; Gastrectomy

• Registration Number: NCT03939819
• Lead Sponsor: Emory University

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).

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 Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-07-30
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-02
• Results First Submitted: 2023-02-01
• Results First Submitted QC: 2023-03-05
• Results First Posted: 2023-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Staple Load Firings	During sleeve gastrectomy (up to 5 hours)	Staple usage will be recorded during the weight loss surgery procedure.

Secondary Outcome Measures

Name	Time	Method
Intra-operative Cost for Patients	During sleeve gastrectomy (up to 5 hours)	Cost data (administrative data) will be retrieved from internal database
Operative Duration (Time)	During sleeve gastrectomy (up to 5 hours)	Surgery start and completion time will be recorded, and operative duration will be calculated
GERD Symptom Severity Score	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. 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
Body Weight	3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)	Total body weight was calculated in Kg.

Trial Locations

Locations (1)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States