Trial Outcomes & Findings for Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication (NCT NCT01077193)

Last Updated: 2014-02-07

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

3 years

Results posted on

2014-02-07

Participant Flow

The enrollment period began in October 2009 and ended in November 2010 at three sites (1 academic site, 2 medical clinics).

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.

Participant milestones

Participant milestones
Measure	Gastric Plication Surgery 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 Study STARTED	44
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Reasons for withdrawal
Measure	Gastric Plication Surgery 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 Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2
Overall Study Lack of Efficacy	1
Overall Study Study Terminated by Sponsor	40

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastric Plication Surgery n=44 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.4 years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants
Region of Enrollment Czech Republic	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Outcome measures
Measure	Gastric Plication Surgery n=44 Participants 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.
Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward	37.9 percentage of baseline excess weight Standard Deviation 25.18

Adverse Events

Gastric Plication Surgery

Serious events: 8 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gastric Plication Surgery n=44 participants at risk 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.
Cardiac disorders Atrial Fibrillation	2.3% 1/44 • Number of events 1
Cardiac disorders Atrioventricular block	2.3% 1/44 • Number of events 1
Cardiac disorders Left ventricular hypertrophy	2.3% 1/44 • Number of events 1
Cardiac disorders Palpitations	2.3% 1/44 • Number of events 1
Eye disorders Cataract	2.3% 1/44 • Number of events 1
Gastrointestinal disorders Gastric perforatin	2.3% 1/44 • Number of events 1
Gastrointestinal disorders Nausea	2.3% 1/44 • Number of events 1
Gastrointestinal disorders Pancreatitis	2.3% 1/44 • Number of events 1
Gastrointestinal disorders Vomiting	2.3% 1/44 • Number of events 1
Hepatobiliary disorders Cholelithiasis	6.8% 3/44 • Number of events 3
Infections and infestations Abdominal sepsis	2.3% 1/44 • Number of events 1
Injury, poisoning and procedural complications Contusion	2.3% 1/44 • Number of events 1
Injury, poisoning and procedural complications Epicondylitis	2.3% 1/44 • Number of events 1
Injury, poisoning and procedural complications Incisional hernia	2.3% 1/44 • Number of events 1
Injury, poisoning and procedural complications Joint sprain	2.3% 1/44 • Number of events 3
Injury, poisoning and procedural complications Overdose	2.3% 1/44 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	2.3% 1/44 • Number of events 1
Renal and urinary disorders Bladder obstruction	2.3% 1/44 • Number of events 1
Reproductive system and breast disorders Benign prostatic hyperplasia	2.3% 1/44 • Number of events 1
Respiratory, thoracic and mediastinal disorders Atelectasis	2.3% 1/44 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 1/44 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 1/44 • Number of events 1
Vascular disorders Haemorrhage	2.3% 1/44 • Number of events 1

Other adverse events

Other adverse events
Measure	Gastric Plication Surgery n=44 participants at risk 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.
Gastrointestinal disorders Nausea	90.9% 40/44 • Number of events 45
Gastrointestinal disorders Abdominal pain	45.5% 20/44 • Number of events 25
Injury, poisoning and procedural complications Procedural pain	45.5% 20/44 • Number of events 20
Gastrointestinal disorders Vomiting	38.6% 17/44 • Number of events 19
Investigations Body temperature increased	18.2% 8/44 • Number of events 8
Gastrointestinal disorders Gastrooesophageal reflux disease	15.9% 7/44 • Number of events 7
Gastrointestinal disorders Constipation	11.4% 5/44 • Number of events 5
Musculoskeletal and connective tissue disorders Back pain	11.4% 5/44 • Number of events 6
Skin and subcutaneous tissue disorders Alopecia	11.4% 5/44 • Number of events 5
Gastrointestinal disorders Abdominal pain upper	9.1% 4/44 • Number of events 4
Gastrointestinal disorders Dyspepsia	9.1% 4/44 • Number of events 4
Hepatobiliary disorders Cholelithiasis	9.1% 4/44 • Number of events 5
Infections and infestations Urinary tract infection	9.1% 4/44 • Number of events 4
Gastrointestinal disorders Hiatus hernia	6.8% 3/44 • Number of events 3
General disorders Non-cardiac chest pain	6.8% 3/44 • Number of events 3
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.8% 3/44 • Number of events 3
Nervous system disorders Dizziness	6.8% 3/44 • Number of events 6
Nervous system disorders Headache	6.8% 3/44 • Number of events 7
Vascular disorders Hypertension	6.8% 3/44 • Number of events 3

Additional Information

Michael L. Schwiers

Ethicon-Endo Surgery, Inc.

Phone: 513-337-1172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER