GERDNCT04901429
Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass
A study testing Truncal vagotomy in people with GERD, run by Baylor Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Truncal vagotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are under the age of 18.
- Not eligible for sleeve to bypass revision bariatric surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
Research Project Coordinator, 214-820-4787, ADVANCEDSURGERYRESEARCH@bswhealth.org
Research Manager, 214-820-1722, ADVANCEDSURGERYRESEARCH@bswhealth.org
About this study
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.
- Conditions
- GERD
- Being tested
- Truncal vagotomy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truncal vagotomyProcedure or surgery
Truncal vagotomy will be performed in 50% of patients during other routine procedure.
| Study group | Role | What they receive |
|---|---|---|
| Truncal Vagotomy | Experimental | Truncal vagotomy will be performed during other routine procedure. Receives: Procedure: Truncal vagotomy |
| No Truncal Vagotomy | No intervention | No truncal vagotomy will be performed during other routine procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD-HRQL scores
GERD-HRQL scores
Measured: approximately 6 months post operation
Esophageal pH monitoring
Esophageal pH monitoring
Measured: approximately 6 months post operation
Reflux symptom index questionnaire
Reflux symptom index questionnaire
Measured: approximately 6 months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jul 2021
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901429
- Sponsor's protocol ID
- 021-171
- Status last verified
- May 2025
- First submitted
- 20 May 2021
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass
- ClinicalTrials.gov ID
- NCT04901429
- Acronym / sponsor ID
- 021-171
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Truncal Vagotomy | Experimental | Procedure: Truncal vagotomyTruncal vagotomy will be performed during other routine procedure. |
| No Truncal Vagotomy | No intervention | –No truncal vagotomy will be performed during other routine procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are under the age of 18.
- Not eligible for sleeve to bypass revision bariatric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truncal vagotomyTruncal vagotomy will be performed in 50% of patients during other routine procedure. | Procedure or surgery | Truncal Vagotomy |
Primary outcome
GERD-HRQL scores
Time frame: approximately 6 months post operation
GERD-HRQL scores
Esophageal pH monitoring
Time frame: approximately 6 months post operation
Esophageal pH monitoring
Reflux symptom index questionnaire
Time frame: approximately 6 months post operation
Reflux symptom index questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Truncal vagotomy in people with GERD, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Project Coordinator (214-820-4787, ADVANCEDSURGERYRESEARCH@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD-HRQL scores (time frame: approximately 6 months post operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.