Clinical trial NCT03939819: Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrectomy
Obesity
Keywords: weight loss surgery
laparoscopic sleeve gastrectomy
suction calibration system
bariatric surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)
* 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

Primary outcomes:
measure: Number of Staple Load Firings
timeFrame: During sleeve gastrectomy (up to 5 hours)
Secondary outcomes:
measure: Operative Duration (Time)
timeFrame: During sleeve gastrectomy (up to 5 hours)
measure: Intra-operative Cost for Patients
timeFrame: During sleeve gastrectomy (up to 5 hours)
measure: GERD Symptom Severity Score
timeFrame: 1-2 months prior to surgery, 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
measure: Body Weight
timeFrame: 3 weeks post-operatively (+/- 2 weeks), 12 months post-operatively (+/- 12 - 24 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Elizabeth Hechenbleikner, MD
role: PRINCIPAL_INVESTIGATOR
References: