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Procedure
Gastric Bypass with or without Vagal Nerve Transection for Gastric Bypass
N/A
Waitlist Available
Led By Sugong Chen, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years and older
Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from surgical intervention to five years after surgery
Awards & highlights
Study Summary
This trial looks at whether or not high levels of a stomach acid called gastrin lead to an increased risk of developing sores in the stomach lining.
Who is the study for?
This trial is for adults over 18 with obesity or metabolic disorders who are already planning to have gastric bypass surgery. They must be able to give informed consent. It's not for those under 18, women who are or want to become pregnant soon, or anyone ineligible for the surgery.Check my eligibility
What is being tested?
The study compares two types of gastric bypass surgeries: one where vagal nerves are cut and one where they're left intact. The goal is to see how these methods affect gastrin levels in the blood and if they influence ulcer formation after surgery.See study design
What are the potential side effects?
Potential side effects from both surgical procedures can include nutritional deficiencies, digestive issues like nausea and vomiting, ulcers at the surgical site, and changes in bowel habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am diagnosed with obesity or a metabolic disorder and am undergoing gastric bypass surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from surgical intervention to five years after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from surgical intervention to five years after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Marginal Ulcer
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Gastric Bypass with Transection of Vagal NervesActive Control1 Intervention
Group II: Gastric Bypass Without Transection of Vagal NervesPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
Sanford HealthLead Sponsor
48 Previous Clinical Trials
61,873 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,547 Total Patients Enrolled
Sugong Chen, MDPrincipal InvestigatorSanford Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am able to understand and sign the consent form.I am 18 years old or older.I cannot have gastric bypass surgery.I am diagnosed with obesity or a metabolic disorder and am undergoing gastric bypass surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Gastric Bypass with Transection of Vagal Nerves
- Group 2: Gastric Bypass Without Transection of Vagal Nerves
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being accepted into this experiment?
"Affirmative. Clinicaltrials.gov displays that this medical trial, initially made available on August 31st 2022, is currently recruiting patients. 50 individuals must be enrolled from one location to complete the study."
Answered by AI
How many individuals are engaging with this clinical research?
"Affirmative. Sources on clinicaltrials.gov reveal that this trial, which was initially put up for recruitment on August 31st 2022, is still searching for participants. Exactly 50 people must be found to join the study at 1 particular medical centre."
Answered by AI
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