Hiatal Interrogation in Sleeve Gastrectomy
Public ClinicalTrials.gov record NCT03527810. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Hiatal Interrogation in Sleeve Gastrectomy (HIATUS):a Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The subject will undergo standard pre-operative preparation. Subjects will be evaluated for the presence of bothersome GERD symptoms by GERD questionnaires and use of Proton-Pump Inhibitor (PPI) medications. Those eligible will be approached at their preoperative appointment about participation in the study and consent will be reviewed with subject. Signed consent will be collected from the subject prior to entry into the operating room. After induction of anesthesia, the subject will be randomized to sleeve gastrectomy with or without interrogation of the hiatus. The SG will be performed as per standard approaches already described. In those randomized to interrogation, the hiatus will be opened posteriorly with preservation of the phreno-esophageal ligament where possible, as per standard described techniques. Dissection into the mediastinum will be stopped if no hernia is seen or when appropriate intra-abdominal length of 2 cm of esophagus is created. Once opened, the Hiatal Surface Area (appendix B)17 will be measured, calculated and recorded and when possible, a photo taken of the area. Repair of the crura will then be performed around the sizing tube used to create the sleeve with enough space to allow a 5 mm instrument to be easily inserted. Permanent sutures will be placed posterior to the esophagus. Subjects will be recovered and be discharged per standard protocol. Evaluation for reflux will be conducted pre-operatively and then 3, 6, 12 and 24 months (+/- 30 days) after surgery or on demand if symptoms occur between follow up periods. Many groups advocate the use of PPI for the first 30 days after bariatric surgery - accordingly assessments of reflux will not occur until 3 months post operatively when most groups stop prophylactic PPI use. A visit within the first 30 days after surgery (+/- 15 days) should occur to evaluate for potential complications of surgery.
Study identification
- NCT ID
- NCT03527810
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Interventions
- Sleeve Gastrectomy Without Interrogation of Hiatus Procedure
- Sleeve Gastrectomy With Interrogation of Hiatus Procedure
Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 3, 2018
- Primary completion
- Mar 6, 2022
- Completion
- Mar 6, 2022
- Last update posted
- Mar 31, 2022
2018 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03527810, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 31, 2022 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03527810 live on ClinicalTrials.gov.