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GERD Following Laparoscopic Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT02476474
Recruitment Status : Not yet recruiting
First Posted : June 19, 2015
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: 3 cm start of resection Procedure: 6 cm start of resection Not Applicable

Detailed Description:
Laparoscopic Sleeve Gastrectomy (LSG), a purely restrictive procedure, has become recently one of the most popular bariatric surgical procedures in this decade because its surgical technique is simple but outcomes in regards to weight loss and co-morbidities improvement are excellent comparable to other procedures. Nevertheless, this procedure carries one potential drawback namely "gastroesophageal reflux disease (GERD). The impact on GERD following LSG are inconsistent . Additionally, the recent literature can be divided into two categories: those that support an increase in GERD prevalence after LSG and those that demonstrate a decrease in GERD prevalence after LSG. Postoperatively, one of the proposed mechanisms for either increased or decreased GERD prevalence is gastric emptying time. Delayed gastric emptying time can contribute to increase intra-gastric volume and pressure resulting in an increase in prevalence of GERD after surgery. On the other hand, accelerated gastric emptying time can cause decrease in GERD prevalence because of decrease in stomach volume and interorgan pressure after operation. In addition, LSG creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure. The investigators hypothesize that a larger amount of gastric antrum will result in accelerated gastric emptying time which leads to less GERD prevalence. On the contrary, the less the remaining gastric antrum would result in delayed gastric emptying which contribute to more GERD prevalence. The investigators plan on identifying the prevalence of GERD in the patients who undergo LSG comparing those who have the sleeve beginning either 3 cm. or 6 cm. from pylorus. We will utilize 24 hour esophageal pH monitoring, esophageal manometry, upper gastrointestinal scintigraphy and esophagogastroduodenoscopy at preoperatively, 3 and 6 month postoperatively. Ultimately, this study will help further clarify the most proper starting resected point of LSG (3 versus 6 cm. from pylorus) which results in the least GERD prevalence after surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Antral Length and GERD Following Sleeve Gastrectomy for Morbid
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: 3 cm start of resection
The line of resection for the Laparoscopic Sleeve gastrectomy will start at 3 cm from pylorus (antrum).
Procedure: 3 cm start of resection
Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.

Active Comparator: 6 cm start of resection
The line of resection for the Laparoscopic Sleeve gastrectomy will start at 6 cm from pylorus (antrum).
Procedure: 6 cm start of resection
Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.




Primary Outcome Measures :
  1. Time of gastric emptying [ Time Frame: 6 months post surgery ]

Secondary Outcome Measures :
  1. Number of participants with GERD [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any subject who has already been already cleared for and scheduled to undergo laparoscopic sleeve gastrectomy for the treatment of morbid obesity(Utilizing NIH1991 guideline for bariatric surgery)

Exclusion Criteria:

  1. Patients not meeting entry criteria to undergo bariatric surgery procedures.
  2. Refusal to give informed consent.
  3. Age <18 or >70.
  4. Prior small intestinal or gastric resective surgery
  5. Existing coagulopathy (INR>2.0, platelet count<100,000)
  6. Severe reflux esophagitis.( Los Angeles Classification for erosive esophagitis grade C,D)
  7. Hiatal hernia > 2 cm(according to esophageal manometry or EGD)
  8. Acquired or Congenital Immunodeficiencies
  9. White blood cell count below normal range.
  10. Azotemia - serum creatinine > 2.0 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476474


Contacts
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Contact: John P Cello, MD 415-206-4767 john.cello@ucsf.edu
Contact: Stanley J Rogers, MD 415-476-0762 stan.rogers@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: John P Cello, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02476474    
Other Study ID Numbers: 133508
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms