Hiatal Interrogation in Sleeve Gastrectomy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/14/2018 |
| Start Date: | September 4, 2018 |
| End Date: | September 2022 |
| Contact: | Laura Sarmiento |
| Email: | Laura.Sarmiento@cshs.org |
| Phone: | 3104234295 |
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 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.
the presence of bothersome GERD symptoms by GERD questionnaires and use of 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.
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 SG7,8 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.
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 SG7,8 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.
Inclusion Criteria:
1. Any patient deemed a candidate for Sleeve Gastrectomy
2. Age 18 years or older
3. 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
Exclusion Criteria:
1. The presence of one or more of the following will be reason for exclusion:
1. Daily Proton Pump Inhibitor ( use for typical GERD symptoms
2. GERD HRQL (Health Related Quality of Life) questions greater than or equal to 15.
2. Hiatal hernia greater than 2cm by either preoperative endoscopy or UGI within one year
of evaluation for bariatric surgery.
3. The Los Angeles classification of the severity of reflux esophagitis: C,D
4. Barrett's esophagus
5. Dysphagia with poor esophageal function measured by motility testing.
6. Does not meet National Institute of Health's weight loss surgery criteria.
7. Inability to commit to no pregnancy for 18 months post operatively.
8. Gastroparesis as defined by 4 hour nuclear emptying study.
9. Previous bariatric surgery.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Miguel Burch, MD
Phone: 310-423-4295
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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