NCT02476474

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
8 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 3, 2015

Last Update Submit

June 8, 2022

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Time of gastric emptying

    6 months post surgery

Secondary Outcomes (1)

  • Number of participants with GERD

    3 months

Study Arms (2)

3 cm start of resection

ACTIVE COMPARATOR

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

Procedure: 3 cm start of resection

6 cm start of resection

ACTIVE COMPARATOR

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

Procedure: 6 cm start of resection

Interventions

3 cm start of resectionPROCEDURE

Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.

3 cm start of resection
6 cm start of resectionPROCEDURE

Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.

6 cm start of resection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 18663545BACKGROUND

  • 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.

    PMID: 23956846BACKGROUND

  • 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.

    PMID: 21130052BACKGROUND

  • 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.

    PMID: 19714384BACKGROUND

  • 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.

    PMID: 18098398BACKGROUND

  • 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.

    PMID: 19089519BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John P Cello, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 19, 2015

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 13, 2022

Record last verified: 2022-06