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

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01077193
• Collaborator: (none)
• Enrollment: 44
• Locations: 3
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Gastric Plication	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Other: Gastric Plication Surgery

Procedure: 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.

Outcome Measures

Primary Outcome Measures

1. Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward [3 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is willing to give consent and comply with evaluation and treatment schedule (for female patients, this includes agreement to use a reliable (per investigator) form of birth control for the duration of the trial);

2. 18 to 65 years of age (inclusive);

3. Subject meets ASMBS and NIH criteria: (consensus.nih.gov)

BMI ³ 40 kg/m2 and £ 50 kg/m2; or, BMI 35-40 kg/m2 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss, including:

• Hyperlipidemia

• Mild obstructive sleep apnea (per Investigator discretion)

• Hypertension

• Osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated;

1. ASA Class I - III;

2. 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;

3. HbA1C < 11%; and

4. For subjects who have Type 2 diabetes, medication regimen is no more complex (2 oral medications) than oral metformin plus one oral sulfonylurea plus once daily insulin injection.

Exclusion Criteria:

1. Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;

2. Previous malabsorptive or restrictive procedures performed for the treatment of obesity;

3. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;

4. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;

5. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts;

6. Participation in any other investigational device or drug study (non-survey based trial; long-term enrollment in such studies as requiring periodic laboratory tests, etc., would be allowed) within 12 weeks of enrollment;

7. Any condition which precludes compliance with the study, including:

8. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration, duodenal ulceration, or specific inflammation such as Crohn's disease or ulcerative colitis that have been active within the past 10 years;

9. Congenital or acquired anomalies of the GI tract, including atresias or stenosis;

10. Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;

11. Uncontrolled hypertension;

12. Portal hypertension;

13. Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);

14. Cirrhosis;

15. Congenital or acquired intestinal telangiectasia;

16. Esophageal or gastric disorders including moderate severe preoperative reflux, dysmotility, or Barrett's esophagus;

17. Presence of hiatal hernia greater than 2cm in length, with the exception of a small sliding hiatal hernia previously undiagnosed and discovered during the surgical procedure;

18. Prior surgery of the foregut including hiatal hernia repair or prior gastric surgery;

19. Known history of clotting disorders, hemoglobinopathies, and hemolytic disorders, including pulmonary embolus and Deep Vein Thrombosis;

20. Pancreatitis;

21. Gallstones (confirmed via ultrasound);

22. Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;

23. Use of thiazolidinediones ("glitazones"), or

24. Conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study;

25. History or presence of pre-existing autoimmune connective tissue disease; and

26. Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195
2	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
3	OB Klinika, a.s.	Prague		Czech Republic

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ethicon Endo-Surgery
• ClinicalTrials.gov Identifier: NCT01077193
• Other Study ID Numbers: CI-09-0006
• First Posted: Mar 1, 2010
• Last Update Posted: Feb 7, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Ethicon Endo-Surgery: Bariatric; Obesity
• Additional relevant MeSH terms: Obesity, Morbid; Weight Loss

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Gastric Plication Surgery
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 Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.4 (10.43)
Sex: Female, Male (Count of Participants)
Female	37 84.1%
Male	7 15.9%
Region of Enrollment (participants) [Number]
United States	29 65.9%
Czech Republic	15 34.1%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Excess Weight Loss at 3 Years With Last Observation Carried Forward
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Gastric Plication Surgery
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.
Measure Participants	44
Mean (Standard Deviation) [percentage of baseline excess weight]	37.9 (25.18)

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
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

Adverse Events

Arm/Group Title	Gastric Plication Surgery
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Gastric Plication Surgery
	Affected / at Risk (%)	# Events
Total	8/44 (18.2%)
Cardiac disorders
Atrial Fibrillation	1/44 (2.3%)	1
Atrioventricular block	1/44 (2.3%)	1
Left ventricular hypertrophy	1/44 (2.3%)	1
Palpitations	1/44 (2.3%)	1
Eye disorders
Cataract	1/44 (2.3%)	1
Gastrointestinal disorders
Gastric perforatin	1/44 (2.3%)	1
Nausea	1/44 (2.3%)	1
Pancreatitis	1/44 (2.3%)	1
Vomiting	1/44 (2.3%)	1
Hepatobiliary disorders
Cholelithiasis	3/44 (6.8%)	3
Infections and infestations
Abdominal sepsis	1/44 (2.3%)	1
Injury, poisoning and procedural complications
Contusion	1/44 (2.3%)	1
Epicondylitis	1/44 (2.3%)	1
Incisional hernia	1/44 (2.3%)	1
Joint sprain	1/44 (2.3%)	3
Overdose	1/44 (2.3%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/44 (2.3%)	1
Renal and urinary disorders
Bladder obstruction	1/44 (2.3%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/44 (2.3%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/44 (2.3%)	1
Pulmonary embolism	1/44 (2.3%)	1
Respiratory failure	1/44 (2.3%)	1
Vascular disorders
Haemorrhage	1/44 (2.3%)	1
Other (Not Including Serious) Adverse Events
	Gastric Plication Surgery
	Affected / at Risk (%)	# Events
Total	43/44 (97.7%)
Gastrointestinal disorders
Nausea	40/44 (90.9%)	45
Abdominal pain	20/44 (45.5%)	25
Vomiting	17/44 (38.6%)	19
Gastrooesophageal reflux disease	7/44 (15.9%)	7
Constipation	5/44 (11.4%)	5
Abdominal pain upper	4/44 (9.1%)	4
Dyspepsia	4/44 (9.1%)	4
Hiatus hernia	3/44 (6.8%)	3
General disorders
Non-cardiac chest pain	3/44 (6.8%)	3
Hepatobiliary disorders
Cholelithiasis	4/44 (9.1%)	5
Infections and infestations
Urinary tract infection	4/44 (9.1%)	4
Injury, poisoning and procedural complications
Procedural pain	20/44 (45.5%)	20
Investigations
Body temperature increased	8/44 (18.2%)	8
Musculoskeletal and connective tissue disorders
Back pain	5/44 (11.4%)	6
Musculoskeletal pain	3/44 (6.8%)	3
Nervous system disorders
Dizziness	3/44 (6.8%)	6
Headache	3/44 (6.8%)	7
Skin and subcutaneous tissue disorders
Alopecia	5/44 (11.4%)	5
Vascular disorders
Hypertension	3/44 (6.8%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.