Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass
ConditionGERD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute
About this trial
The purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the severity and/or incidence of gastroesophageal reflux disease (GERD) post-surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participating subjects will need to be >18yrs of age and eligible for sleeve to bypass revision bariatric surgery.
Undergoing sleeve to bypass revision bariatric surgery.
Disqualifiers
Patients who are under the age of 18.
Not eligible for sleeve to bypass revision bariatric surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Truncal vagotomy
Procedure/SurgeryTruncal vagotomy will be performed in 50% of patients during other routine procedure.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Truncal VagotomyExperimental treatment 1 intervention
Group B: No Truncal VagotomyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
GERD-HRQL scores
GERD-HRQL scores
Time frame
approximately 6 months post operation2
Esophageal pH monitoring
Esophageal pH monitoring
Time frame
approximately 6 months post operation3
Reflux symptom index questionnaire
Reflux symptom index questionnaire
Time frame
approximately 6 months post operationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov