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GERD Following Laparoscopic Sleeve Gastrectomy

Primary Purpose

Morbid Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3 cm start of resection
6 cm start of resection
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    3 cm start of resection

    6 cm start of resection

    Arm Description

    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 3 cm from pylorus (antrum).

    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 6 cm from pylorus (antrum).

    Outcomes

    Primary Outcome Measures

    Time of gastric emptying

    Secondary Outcome Measures

    Number of participants with GERD

    Full Information

    First Posted
    June 3, 2015
    Last Updated
    June 8, 2022
    Sponsor
    University of California, San Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02476474
    Brief Title
    GERD Following Laparoscopic Sleeve Gastrectomy
    Official Title
    Antral Length and GERD Following Sleeve Gastrectomy for Morbid
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn due to a lack of funding
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3 cm start of resection
    Arm Type
    Active Comparator
    Arm Description
    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 3 cm from pylorus (antrum).
    Arm Title
    6 cm start of resection
    Arm Type
    Active Comparator
    Arm Description
    The line of resection for the Laparoscopic Sleeve gastrectomy will start at 6 cm from pylorus (antrum).
    Intervention Type
    Procedure
    Intervention Name(s)
    3 cm start of resection
    Intervention Description
    Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.
    Intervention Type
    Procedure
    Intervention Name(s)
    6 cm start of resection
    Intervention Description
    Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.
    Primary Outcome Measure Information:
    Title
    Time of gastric emptying
    Time Frame
    6 months post surgery
    Secondary Outcome Measure Information:
    Title
    Number of participants with GERD
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: Patients not meeting entry criteria to undergo bariatric surgery procedures. Refusal to give informed consent. Age <18 or >70. Prior small intestinal or gastric resective surgery Existing coagulopathy (INR>2.0, platelet count<100,000) Severe reflux esophagitis.( Los Angeles Classification for erosive esophagitis grade C,D) Hiatal hernia > 2 cm(according to esophageal manometry or EGD) Acquired or Congenital Immunodeficiencies White blood cell count below normal range. Azotemia - serum creatinine > 2.0 mg/dl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John P Cello, MD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18663545
    Citation
    Melissas J, Daskalakis M, Koukouraki S, Askoxylakis I, Metaxari M, Dimitriadis E, Stathaki M, Papadakis JA. Sleeve gastrectomy-a "food limiting" operation. Obes Surg. 2008 Oct;18(10):1251-6. doi: 10.1007/s11695-008-9634-4. Epub 2008 Jul 29.
    Results Reference
    background
    PubMed Identifier
    23956846
    Citation
    Laffin M, Chau J, Gill RS, Birch DW, Karmali S. Sleeve gastrectomy and gastroesophageal reflux disease. J Obes. 2013;2013:741097. doi: 10.1155/2013/741097. Epub 2013 Jul 15.
    Results Reference
    background
    PubMed Identifier
    21130052
    Citation
    Chiu S, Birch DW, Shi X, Sharma AM, Karmali S. Effect of sleeve gastrectomy on gastroesophageal reflux disease: a systematic review. Surg Obes Relat Dis. 2011 Jul-Aug;7(4):510-5. doi: 10.1016/j.soard.2010.09.011. Epub 2010 Sep 21.
    Results Reference
    background
    PubMed Identifier
    19714384
    Citation
    Braghetto I, Davanzo C, Korn O, Csendes A, Valladares H, Herrera E, Gonzalez P, Papapietro K. Scintigraphic evaluation of gastric emptying in obese patients submitted to sleeve gastrectomy compared to normal subjects. Obes Surg. 2009 Nov;19(11):1515-21. doi: 10.1007/s11695-009-9954-z. Epub 2009 Aug 28.
    Results Reference
    background
    PubMed Identifier
    18098398
    Citation
    Weiner RA, Weiner S, Pomhoff I, Jacobi C, Makarewicz W, Weigand G. Laparoscopic sleeve gastrectomy--influence of sleeve size and resected gastric volume. Obes Surg. 2007 Oct;17(10):1297-305. doi: 10.1007/s11695-007-9232-x.
    Results Reference
    background
    PubMed Identifier
    19089519
    Citation
    Bernstine H, Tzioni-Yehoshua R, Groshar D, Beglaibter N, Shikora S, Rosenthal RJ, Rubin M. Gastric emptying is not affected by sleeve gastrectomy--scintigraphic evaluation of gastric emptying after sleeve gastrectomy without removal of the gastric antrum. Obes Surg. 2009 Mar;19(3):293-8. doi: 10.1007/s11695-008-9791-5. Epub 2008 Dec 17.
    Results Reference
    background

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    GERD Following Laparoscopic Sleeve Gastrectomy

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