NCT01703546

Brief Summary

The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

August 10, 2012

Last Update Submit

January 12, 2016

Conditions

Morbid Obesity

Keywords

Morbid ObesityWeight Loss SurgeryLaparoscopic Adjustable Gastric BandLaparoscopic Gastric PlicationImbrication

Outcome Measures

Primary Outcomes (1)

  • % Excess Body Weight Loss (%EWL)

    Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater.

    6 months post procedure

Secondary Outcomes (1)

  • HgbA1c

    12 months post procedure

Study Arms (1)

LAGB & LGCP

EXPERIMENTAL

All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB \& LGCP). The percent of Excess Body Weight Loss will be monitored at all post op visits.

Procedure: LAGB & LGCP

Interventions

LAGB & LGCPPROCEDURE

All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band \& Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.

Also known as: Laparoscopic Adjustable Gastric Band & Gastric Plication
LAGB & LGCP

Eligibility Criteria

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

You may qualify if:

  • Body Mass Index (BMI) \> 35
  • Meet ASMBS and NIH criteria for Weight Loss Surgery
  • ASA Class I - III
  • Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial.
  • English speaking \& comprehension
  • Normal mental caliber.

You may not qualify if:

  • Pregnancy, Liver failure or Kidney failure
  • Women of childbearing potential lactating at the time of initial consult or at the time of surgery
  • Any condition which precludes compliance with the study
  • History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike

Syosset, New York, 11791, United States

Location

Syosset Hospital, Center for Bariatric Surgical Specialties

Syosset, New York, 11791, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Ward, MD

    North Shore LIJ Health System, Syosset Hospital, Director of Surgery

    STUDY CHAIR

  • Allison Barrett, MD

    North Shore LIJ Health System Syosset Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2012

First Posted

October 10, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(2)