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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

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE June 19, 2015
Last Update Posted Date May 18, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
Time of gastric emptying [ Time Frame: 6 months post surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2015)
Number of participants with GERD [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GERD Following Laparoscopic Sleeve Gastrectomy
Official Title  ICMJE Antral Length and GERD Following Sleeve Gastrectomy for Morbid
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Morbid Obesity
Intervention  ICMJE
  • Procedure: 3 cm start of resection
    Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.
  • Procedure: 6 cm start of resection
    Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.
Study Arms  ICMJE
  • Active Comparator: 3 cm start of resection
    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 3 cm from pylorus (antrum).
    Intervention: Procedure: 3 cm start of resection
  • Active Comparator: 6 cm start of resection
    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 6 cm from pylorus (antrum).
    Intervention: Procedure: 6 cm start of resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John P Cello, MD 415-206-4767 john.cello@ucsf.edu
Contact: Stanley J Rogers, MD 415-476-0762 stan.rogers@ucsf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02476474
Other Study ID Numbers  ICMJE 133508
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John P Cello, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP