N/A N=106 Randomized Treatment

Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy

Gastrectomy · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT03939819 ↗

Enrolled (actual)

106

Serious AEs

1.9%

Results posted

Mar 2023

Primary outcome: Primary: Number of Staple Load Firings — 5.26; 5.42 Number of staples

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ViSiGi® 3D suction calibration device (Device); Esophagogastroduodenoscopy (EGD) calibration (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Staple Load Firings	5.26; 5.42	—
SECONDARY Operative Duration (Time)	93.38; 94.42	—
SECONDARY Intra-operative Cost for Patients	—	—
SECONDARY GERD Symptom Severity Score	4.54; 3.82; 3.00; 5.66; 2.58; 2.64	—
SECONDARY Body Weight	108.2; 106.7	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03939819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.