NCT01564732

Brief Summary

The purpose of this study is to compare plicated laparoscopic adjustable gastric banding (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective randomized clinical trial. We hypothesize the plicated procedure will provide greater short- and long-term excess weight loss than the standard procedure. There exists little prospective randomized data regarding this topic and the recent position statement from the American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further information on background and design of this study are provided in the detailed description.

Trial Health

57
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Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
terminated

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

March 7, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

March 7, 2012

Results QC Date

April 25, 2016

Last Update Submit

June 3, 2016

Conditions

Morbid Obesity

Keywords

morbid obesitygastric band

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    36 months

Secondary Outcomes (5)

  • Quality of Life

    36 months

  • Quantitative Change in Hypertension

    36 months

  • Quantitative Change in Diabetes

    36 months

  • Quantitative Change in Hyperlipidemia

    36 months

  • Quantitative Change in Hypertriglyceridemia

    36 months

Study Arms (2)

Standard-LAGB

ACTIVE COMPARATOR

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Device: Standard-LAGB

Plicated-LAGB

EXPERIMENTAL

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Device: Plicated-LAGB

Interventions

Standard-LAGBDEVICE

The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Also known as: Standard Laparoscopic Adjustable Gastric Banding Surgery
Standard-LAGB
Plicated-LAGBDEVICE

At the time of LAGB placement, plication sutures can be placed along the body \& greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Also known as: Plicated Laparoscopic Adjustable Gastric Banding Surgery
Plicated-LAGB

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-60 years,
  • Morbidly obese:
  • a. BMI \> 40, or b. BMI \> 35 + co-morbid obesity related disease condition c)BMI \< or equal to 55

You may not qualify if:

  • Patients with any major medical problems contraindicating surgery (eg.myocardial infarct within last 6 months, cancer within last 5 years, end stage renal/liver disease, etc.)
  • Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
  • Patients who elect to undergo a surgery other than a PLAGB or SLAGB
  • Patient who is unwilling to be randomized to PLAGB or SLAGB
  • Pregnant or planning pregnancy within 12 months
  • Alcohol or drug addiction
  • Established infection anywhere in the body at the time of surgery
  • Previous history of bariatric surgery, gastric surgery, intestinal obstruction, or adhesive peritonitis.
  • Family or patient history of autoimmune disease
  • Hiatal Hernia \> 3cm (as reported per radiology on pre-operative swallow study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (10)

  • Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.

    PMID: 20071471BACKGROUND

  • Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.

    PMID: 15479938BACKGROUND

  • Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

    PMID: 17715408BACKGROUND

  • Pories WJ. Bariatric surgery: risks and rewards. J Clin Endocrinol Metab. 2008 Nov;93(11 Suppl 1):S89-96. doi: 10.1210/jc.2008-1641.

    PMID: 18987275BACKGROUND

  • Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.

    PMID: 19641201BACKGROUND

  • Gravante G, Araco A, Araco F, Delogu D, De Lorenzo A, Cervelli V. Laparoscopic adjustable gastric bandings: a prospective randomized study of 400 operations performed with 2 different devices. Arch Surg. 2007 Oct;142(10):958-61. doi: 10.1001/archsurg.142.10.958.

    PMID: 17938309BACKGROUND

  • Cottam DR, Atkinson J, Anderson A, Grace B, Fisher B. A case-controlled matched-pair cohort study of laparoscopic Roux-en-Y gastric bypass and Lap-Band patients in a single US center with three-year follow-up. Obes Surg. 2006 May;16(5):534-40. doi: 10.1381/096089206776944913.

    PMID: 16687018BACKGROUND

  • Hussain A, Mahmood H, El-Hasani S. Gastric plication can reduce slippage rate after laparoscopic gastric banding. JSLS. 2010 Apr-Jun;14(2):221-7. doi: 10.4293/108680810X12785289144241.

    PMID: 20932373BACKGROUND

  • Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.

    PMID: 17356932BACKGROUND

  • Lancaster RT, Hutter MM. Bands and bypasses: 30-day morbidity and mortality of bariatric surgical procedures as assessed by prospective, multi-center, risk-adjusted ACS-NSQIP data. Surg Endosc. 2008 Dec;22(12):2554-63. doi: 10.1007/s00464-008-0074-y. Epub 2008 Sep 20.

    PMID: 18806945BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dana Portenier, M.D.
Organization
Duke University Medical Center
dana.portenier@duke.edu
919-470-7031

Study Officials

  • Dana D Portenier, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Carol McCloskey, MD

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 28, 2012

Study Start

September 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 1, 2016

Results First Posted

June 1, 2016

Record last verified: 2016-06

Locations

US(1)