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Withdrawn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
About this trial
This is an interventional basic science trial for Morbid Obesity
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
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
NCT ID
NCT02476474
First Posted
June 3, 2015
Last Updated
June 8, 2022
Sponsor
University of California, San Francisco
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Withdrawn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Study withdrawn due to a lack of funding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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