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Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication

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ClinicalTrials.gov Identifier: NCT01077193
Recruitment Status : Terminated (Study was terminated due to commercial considerations and potential patient attrition at 3 years. There were no patient safety or procedure efficacy reasons.)
First Posted : March 1, 2010
Results First Posted : September 13, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Morbid Obesity
Intervention Procedure: Gastric Plication
Enrollment 44
Recruitment Details The enrollment period began in October 2009 and ended in November 2010 at three sites (1 academic site, 2 medical clinics).
Pre-assignment Details No significant events were involved - subjects were evaluated for inclusion and exclusion criteria and proceeded to surgery if they qualified. This is a 1-arm trial.
Arm/Group Title Gastric Plication Surgery
Hide Arm/Group Description

Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.

The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.

At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Period Title: Overall Study
Started 44
Completed 0
Not Completed 44
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             2
Lack of Efficacy             1
Study Terminated by Sponsor             40
Arm/Group Title Gastric Plication Surgery
Hide Arm/Group Description

Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.

The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.

At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
Intent-to-Treat Population: All subjects who underwent the gastric plication surgery.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
44
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
43.4  (10.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
37
  84.1%
Male
7
  15.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
United States 29
Czech Republic 15
1.Primary Outcome
Title Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward
Hide Description

Percent excess weight change from baseline to 3 years was calculated as (the baseline weight minus the weight at 3 years) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects.

One-sided, alpha=0.025, t-test of the Percent Excess Weight Loss (EWL) at 3-years to demonstrate non-inferiority to the target weight loss value of 41.1%EWL

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gastric Plication Surgery
Hide Arm/Group Description:

Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.

The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.

At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: percentage of baseline excess weight
37.9  (25.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gastric Plication Surgery
Comments A sample size of 32 achieves power>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.
Type of Statistical Test Non-Inferiority or Equivalence
Comments See above.
Statistical Test of Hypothesis P-Value 0.3227
Comments No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Percent Excess Weight Loss
Estimated Value 37.9
Confidence Interval (2-Sided) 95%
30.2 to 45.5
Parameter Dispersion
Type: Standard Deviation
Value: 25.18
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gastric Plication Surgery
Hide Arm/Group Description

Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.

The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.

At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.

All-Cause Mortality
Gastric Plication Surgery
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Gastric Plication Surgery
Affected / at Risk (%) # Events
Total   8/44 (18.18%)    
Cardiac disorders   
Atrial Fibrillation  1  1/44 (2.27%)  1
Atrioventricular block  1  1/44 (2.27%)  1
Left ventricular hypertrophy  1  1/44 (2.27%)  1
Palpitations  1  1/44 (2.27%)  1
Eye disorders   
Cataract  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Gastric perforatin  1  1/44 (2.27%)  1
Nausea  1  1/44 (2.27%)  1
Pancreatitis  1  1/44 (2.27%)  1
Vomiting  1  1/44 (2.27%)  1
Hepatobiliary disorders   
Cholelithiasis  1  3/44 (6.82%)  3
Infections and infestations   
Abdominal sepsis  1  1/44 (2.27%)  1
Injury, poisoning and procedural complications   
Contusion  1  1/44 (2.27%)  1
Epicondylitis  1  1/44 (2.27%)  1
Incisional hernia  1  1/44 (2.27%)  1
Joint sprain  1  1/44 (2.27%)  3
Overdose  1  1/44 (2.27%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  1/44 (2.27%)  1
Renal and urinary disorders   
Bladder obstruction  1  1/44 (2.27%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/44 (2.27%)  1
Pulmonary embolism  1  1/44 (2.27%)  1
Respiratory failure  1  1/44 (2.27%)  1
Vascular disorders   
Haemorrhage  1  1/44 (2.27%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gastric Plication Surgery
Affected / at Risk (%) # Events
Total   43/44 (97.73%)    
Gastrointestinal disorders   
Nausea  40/44 (90.91%)  45
Abdominal pain  20/44 (45.45%)  25
Vomiting  17/44 (38.64%)  19
Gastrooesophageal reflux disease  7/44 (15.91%)  7
Constipation  5/44 (11.36%)  5
Abdominal pain upper  4/44 (9.09%)  4
Dyspepsia  4/44 (9.09%)  4
Hiatus hernia  3/44 (6.82%)  3
General disorders   
Non-cardiac chest pain  3/44 (6.82%)  3
Hepatobiliary disorders   
Cholelithiasis  4/44 (9.09%)  5
Infections and infestations   
Urinary tract infection  4/44 (9.09%)  4
Injury, poisoning and procedural complications   
Procedural pain  20/44 (45.45%)  20
Investigations   
Body temperature increased  8/44 (18.18%)  8
Musculoskeletal and connective tissue disorders   
Back pain  5/44 (11.36%)  6
Musculoskeletal pain  3/44 (6.82%)  3
Nervous system disorders   
Dizziness  3/44 (6.82%)  6
Headache  3/44 (6.82%)  7
Skin and subcutaneous tissue disorders   
Alopecia  5/44 (11.36%)  5
Vascular disorders   
Hypertension  3/44 (6.82%)  3
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed that the first publication should be made in conjunction with the presentation of a joint, multicenter publication with the PIs from all sites contributing data, analyses, and comments. If this publication was not submitted within 12 months after conclusion of the Study at all sites, termination of the Study at all sites, or after Sponsor confirmed there would be no multicenter Study publication, whichever is first, the PIs could publish the results from their individual sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael L. Schwiers
Organization: Ethicon-Endo Surgery, Inc.
Phone: 513-337-1172
EMail: mschwier@its.jnj.com
Layout table for additonal information
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01077193    
Other Study ID Numbers: CI-09-0006
First Submitted: February 25, 2010
First Posted: March 1, 2010
Results First Submitted: July 9, 2013
Results First Posted: September 13, 2013
Last Update Posted: February 7, 2014