Sleeve GastrectomyNCT03527810
Hiatal Interrogation in Sleeve Gastrectomy
A study testing Sleeve Gastrectomy Without Interrogation of Hiatus and Sleeve Gastrectomy With Interrogation of Hiatus in people with Sleeve Gastrectomy, run by Miguel Burch at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleeve Gastrectomy
- What is being tested?
- Sleeve Gastrectomy Without Interrogation of Hiatus and Sleeve Gastrectomy With Interrogation of Hiatus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 7 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Any patient deemed a candidate for Sleeve Gastrectomy.
- Age 18 years or older.
- Body Mass Index equal or greater to 40 without comorbidities OR Body Mass Index equal or greater than 35 with at least one obesity co-morbidity.
Who cannot join
- The presence of one or more of the following will be reason for exclusion:
- Daily Proton Pump Inhibitor or H2 blocker use for typical GERD symptoms during Screening day to Surgery day
- GERD Health Related Quality of Life (HRQL) questionnaire score greater than or equal to 15.
- Hiatal hernia greater than 2cm by either preoperative endoscopy or Upper gastrointestinal (UGI) within one year of evaluation for bariatric surgery.
- The Los Angeles classification of the severity of reflux esophagitis: C,D
- Barrett's esophagus
Show all 12Show fewer
- Dysphagia with poor esophageal function measured by motility testing.
- Does not meet National Institute of Health's weight loss surgery criteria.
- Inability to commit to no pregnancy for 18 months post operatively.
- Gastroparesis as defined by 4 hour nuclear emptying study.
- Previous bariatric surgery.
- Eosinophilia esophagitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Hiatal Interrogation in Sleeve Gastrectomy (HIATUS):a Clinical Trial
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.
Read the detailed description
The obesity epidemic continues to exist as nearly one third of the adult population in the United States is reported to be obese1. Bariatric surgery remains the most effective method of achieving long-term weight loss among obese individuals. The remarkable success of weight loss surgery in ameliorating obesity and its related comorbid conditions has been tempered by procedure specific side-effect profiles. Gastro-esophageal reflux disease (GERD), a condition which develops when the reflux of stomach contents causes troublesome heartburn or regurgitation symptoms greater than twice a week is a known complication of bariatric surgery and remains a controversial topic among bariatric surgeons.2 The prevalence of GERD in the general Western population is between 10 and 20% 3, whereas the incidence of reflux among the obese population has been reported to be as high as 61%. 4
The safety and maintenance of native intestinal anatomy by the sleeve gastrectomy (SG) has recently made this surgery the most popular operation for weight loss in America 5. The operation, which was originally described as the first stage of a biliopancreatic diversion - duodenal switch, consists of removing approximately 60% of the native stomach. Specifically, the bulbous greater curvature and a portion of the antrum is removed, leaving behind a long, thin banana shaped reservoir with a capacity between 100 and 150 mL. 6 This new stomach offers excellent weight loss and also minimal anatomic rearrangement when compared to the traditional gastric bypass.
Although some authors have reported an improvement in GERD symptoms after SG many studies have demonstrated an increase in GERD symptoms9-14. Particularly concerning is the development of de-novo GERD symptoms after surgery, which has recently been reported to occur in up to 36% of patients when measured objectively.15 In some, GERD symptoms are severe enough, despite medication, that corrective operations are required. The need for further re-operative surgery carries along with it the risk for additional perioperative morbidity from gastrointestinal leaks or bleeding as well as further time off work and rehabilitation.
Various mechanisms have been proposed to explain the development of GERD after SG. Some authors postulate that the new shape of the stomach, increased intra-gastric pressure, decrease in the lower esophageal sphincter resting pressure or development of a hiatal hernia may lead to new or worsening GERD. The International Sleeve Gastrectomy Expert Panel recommend aggressively inspecting for and repairing an occult hiatal hernia to decrease the incidence of post-operative GERD.17 This call for "aggressive inspection" has led many surgeons to open the phrenoesophageal ligament and, in a sense, create a small hernia defect which is then sutured closed more tightly. Some believe aggressive interrogation of the hiatus may lead to disruption of the integrity of the sling fibers of Helvetius at the esophagogastric junction, thus contributing to the incidence of new or worsening post-operative GERD. Still, others propose that the main mechanism of GERD reduction is weight loss and not the re-creation of the extrinsic anti-reflux valve.
Whether one should aggressively interrogate and subsequently repair the hiatus during a SG remains controversial. To our knowledge, there are no randomized studies to demonstrate superiority of either approach. The aim is to compare the rates of GERD (de-novo or worsening) in patients undergoing SG between one group receiving hiatal interrogation and repair and the other not having hiatal interrogation at all. Patient are randomized who either have a small hiatal hernia (<2cm) or do not have a hiatal hernia seen on preoperative testing to either hiatal interrogation with cruroplasty of the hiatus or no interrogation. By the end of the study, the study team will be able to provide a recommendation as to whether patients with no or a small hernia undergoing SG should routinely undergo simultaneous hiatal interrogation and repair with the goal of reducing the incidence of PPI de-novo GERD after surgery.
- Conditions
- Sleeve Gastrectomy
- Being tested
- Sleeve Gastrectomy Without Interrogation of Hiatus, Sleeve Gastrectomy With Interrogation of Hiatus
- Keywords
- sleeve gastrectomy, hiatal interrogation, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve Gastrectomy Without Interrogation of HiatusProcedure or surgery
Weight-loss procedure to reduce the stomach.
Sleeve Gastrectomy With Interrogation of HiatusProcedure or surgery
Weight-loss procedure to reduce the stomach with hiatal repair.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy With Interrogation of Hiatus | Experimental | In those randomized to interrogation, the hiatus will be opened posteriorly during surgical procedure intervention 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 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. Receives: Procedure: Sleeve Gastrectomy With Interrogation of Hiatus |
| Sleeve Gastrectomy Without Interrogation of Hiatus | Active comparator | In those randomized without interrogation, the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. The procedure involves a longitudinal resection of the stomach starting from the antrum at the point 5-6 cm from the pylorus and finishing at the fundus close to the cardia.[1] The remaining gastric sleeve is calibrated with a bougie. Most surgeons prefer to use a bougie between 36-40 Fr with the procedure and the ideal approximate remaining size of the stomach after the procedure is about 150 mL. Receives: Procedure: Sleeve Gastrectomy Without Interrogation of Hiatus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patients dependent on proton pump inhibitors therapy for confirmed GERD.
Statistically significant change in total patients on PPI therapy for confirmed GERD (by either questionnaire or pH test confirmed GERD).
Measured: 6 months
Secondary outcomes (4)
Time free from GERD symptoms compared between both groups
number of months
Measured: 24 months
Time free from GERD medications compared between both groups
number of months
Measured: 24 months
Number of patients with symptomatic hiatal hernias at 24 months
number of patients
Measured: 24 months
Number of patients requiring secondary procedures for reflux at 12, 24 months
number of patients
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start4 Sep 2018
- Primary completion7 Mar 2022
- Study completion7 Mar 2022
Why it stopped: interim analysis of the data was not supportive of continuing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleeve GastrectomyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miguel Burch
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor-investigator, Miguel Burch, Cedars-Sinai Medical Center
- Investigators
- Miguel Burch, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527810
- Sponsor's protocol ID
- Pro47769
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2018
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hiatal Interrogation in Sleeve Gastrectomy (HIATUS):a Clinical Trial
- ClinicalTrials.gov ID
- NCT03527810
- Acronym / sponsor ID
- Pro47769
- Conditions
- Sleeve Gastrectomy
- Keywords
- sleeve gastrectomy, hiatal interrogation, GERD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis of the data was not supportive of continuing the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Miguel BurchUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 17 May 2018 (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 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.
Detailed description
The obesity epidemic continues to exist as nearly one third of the adult population in the United States is reported to be obese1. Bariatric surgery remains the most effective method of achieving long-term weight loss among obese individuals. The remarkable success of weight loss surgery in ameliorating obesity and its related comorbid conditions has been tempered by procedure specific side-effect profiles. Gastro-esophageal reflux disease (GERD), a condition which develops when the reflux of stomach contents causes troublesome heartburn or regurgitation symptoms greater than twice a week is a known complication of bariatric surgery and remains a controversial topic among bariatric surgeons.2 The prevalence of GERD in the general Western population is between 10 and 20% 3, whereas the incidence of reflux among the obese population has been reported to be as high as 61%. 4
The safety and maintenance of native intestinal anatomy by the sleeve gastrectomy (SG) has recently made this surgery the most popular operation for weight loss in America 5. The operation, which was originally described as the first stage of a biliopancreatic diversion - duodenal switch, consists of removing approximately 60% of the native stomach. Specifically, the bulbous greater curvature and a portion of the antrum is removed, leaving behind a long, thin banana shaped reservoir with a capacity between 100 and 150 mL. 6 This new stomach offers excellent weight loss and also minimal anatomic rearrangement when compared to the traditional gastric bypass.
Although some authors have reported an improvement in GERD symptoms after SG many studies have demonstrated an increase in GERD symptoms9-14. Particularly concerning is the development of de-novo GERD symptoms after surgery, which has recently been reported to occur in up to 36% of patients when measured objectively.15 In some, GERD symptoms are severe enough, despite medication, that corrective operations are required. The need for further re-operative surgery carries along with it the risk for additional perioperative morbidity from gastrointestinal leaks or bleeding as well as further time off work and rehabilitation.
Various mechanisms have been proposed to explain the development of GERD after SG. Some authors postulate that the new shape of the stomach, increased intra-gastric pressure, decrease in the lower esophageal sphincter resting pressure or development of a hiatal hernia may lead to new or worsening GERD. The International Sleeve Gastrectomy Expert Panel recommend aggressively inspecting for and repairing an occult hiatal hernia to decrease the incidence of post-operative GERD.17 This call for "aggressive inspection" has led many surgeons to open the phrenoesophageal ligament and, in a sense, create a small hernia defect which is then sutured closed more tightly. Some believe aggressive interrogation of the hiatus may lead to disruption of the integrity of the sling fibers of Helvetius at the esophagogastric junction, thus contributing to the incidence of new or worsening post-operative GERD. Still, others propose that the main mechanism of GERD reduction is weight loss and not the re-creation of the extrinsic anti-reflux valve.
Whether one should aggressively interrogate and subsequently repair the hiatus during a SG remains controversial. To our knowledge, there are no randomized studies to demonstrate superiority of either approach. The aim is to compare the rates of GERD (de-novo or worsening) in patients undergoing SG between one group receiving hiatal interrogation and repair and the other not having hiatal interrogation at all. Patient are randomized who either have a small hiatal hernia (<2cm) or do not have a hiatal hernia seen on preoperative testing to either hiatal interrogation with cruroplasty of the hiatus or no interrogation. By the end of the study, the study team will be able to provide a recommendation as to whether patients with no or a small hernia undergoing SG should routinely undergo simultaneous hiatal interrogation and repair with the goal of reducing the incidence of PPI de-novo GERD after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy With Interrogation of Hiatus | Experimental | Procedure: Sleeve Gastrectomy With Interrogation of HiatusIn those randomized to interrogation, the hiatus will be opened posteriorly during surgical procedure intervention 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 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. |
| Sleeve Gastrectomy Without Interrogation of Hiatus | Active comparator | Procedure: Sleeve Gastrectomy Without Interrogation of HiatusIn those randomized without interrogation, the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature. The procedure involves a longitudinal resection of the stomach starting from the antrum at the point 5-6 cm from the pylorus and finishing at the fundus close to the cardia.[1] The remaining gastric sleeve is calibrated with a bougie. Most surgeons prefer to use a bougie between 36-40 Fr with the procedure and the ideal approximate remaining size of the stomach after the procedure is about 150 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient deemed a candidate for Sleeve Gastrectomy.
- Age 18 years or older.
- Body Mass Index equal or greater to 40 without comorbidities OR Body Mass Index equal or greater than 35 with at least one obesity co-morbidity.
Key exclusion criteria (12 listed)
- The presence of one or more of the following will be reason for exclusion:
- Hiatal hernia greater than 2cm by either preoperative endoscopy or Upper gastrointestinal (UGI) within one year of evaluation for bariatric surgery.
- The Los Angeles classification of the severity of reflux esophagitis: C,D
- Barrett's esophagus
- Dysphagia with poor esophageal function measured by motility testing.
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 |
|---|---|---|
| Sleeve Gastrectomy Without Interrogation of HiatusWeight-loss procedure to reduce the stomach. | Procedure or surgery | Sleeve Gastrectomy Without Interrogation of Hiatus |
| Sleeve Gastrectomy With Interrogation of HiatusWeight-loss procedure to reduce the stomach with hiatal repair. | Procedure or surgery | Sleeve Gastrectomy With Interrogation of Hiatus |
Primary outcome
Change in patients dependent on proton pump inhibitors therapy for confirmed GERD.
Time frame: 6 months
Statistically significant change in total patients on PPI therapy for confirmed GERD (by either questionnaire or pH test confirmed GERD).
4 secondary outcomes
Time free from GERD symptoms compared between both groups
Time frame: 24 months
Time free from GERD medications compared between both groups
Time frame: 24 months
Number of patients with symptomatic hiatal hernias at 24 months
Time frame: 24 months
Number of patients requiring secondary procedures for reflux at 12, 24 months
Time frame: 12, 24 months
Results and safety
The study was stopped early (reason given: interim analysis of the data was not supportive of continuing the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Miguel Burch, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve Gastrectomy Without Interrogation of Hiatus and Sleeve Gastrectomy With Interrogation of Hiatus in people with Sleeve Gastrectomy, run by Miguel Burch 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 1 Apr 2022. 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?
The study was stopped early (reason given: interim analysis of the data was not supportive of continuing the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients dependent on proton pump inhibitors therapy for confirmed GERD. (time frame: 6 months). 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 1 Apr 2022.