Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

• Sponsor: Ethicon Endo-Surgery (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721227
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Procedure: Reduction Gastroplasty	N/A

Detailed Description

The overall plan for all subjects consists of the following elements:

• Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD).

• Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures.

• Subjects are followed for 12 months to evaluate outcomes and potential complications.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Anterior Curve Reduction Gastroplasty by Gastric Plication on Anterior Curve	Procedure: Reduction Gastroplasty; Subjects will undergo reduction gastroplasty by gastric plication Subjects are followed for 12 months to evaluate outcomes and potential complications.
Active Comparator: Greater Curve Reduction Gastroplasty by Gastric Plication on Greater Curve	Procedure: Reduction Gastroplasty; Subjects will undergo reduction gastroplasty by gastric plication Subjects are followed for 12 months to evaluate outcomes and potential complications.

Outcome Measures

Primary Outcome Measures

1. Successful Gastric Plication Using Reduction Gastroplasty [Immediately post-operative]

   The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.

Secondary Outcome Measures

1. Durability of Gastric Plications Following Reduction Gastroplasty [12 month]

   The number of participants who completed month 12 gastroscopies showing intact plications.

2. Weight Loss Following Reduction Gastroplasty [12 months]

   Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects are considered appropriate candidates for the study if they fulfill the following criteria:

1. Subject is willing to give consent and comply with evaluation and treatment schedule;

2. 21 to 60 years of age (inclusive);

3. BMI > 35 kg/m2 and < 50 kg/m2 (BMI 35-40 kg/m2 allowable with one or more significant medical conditions related to obesity, including co-morbid conditions of hyperlipidemia, mild obstructive sleep apnea (per Investigators discretion), hypertension, or osteoarthritis of the hip or knee per investigational site's criteria for which the subject is being treated, and which are generally expected to be improved, reversed, or resolved by weight loss);

4. Candidate for surgical weight loss intervention (i.e., meets ASMBS24 and NIH criteria);

5. Absence of significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, per site standard of care (SOC); and

6. Agree to refrain from any type of elective procedures that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for the duration of the trial.

Exclusion Criteria:

Subjects will be excluded from the study for any of the following:

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

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

3. Previous mal-absorptive or restrictive procedures performed for the treatment of obesity;

4. Scheduled concurrent surgical procedure;

5. Participation in any other investigational device or drug study (non survey based trial) within 12 weeks of enrollment;

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

7. 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;

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

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

10. Uncontrolled hypertension;

11. Portal hypertension;

12. Treatment with insulin (more than 50 units a day);

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;

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

19. Pancreatitis;

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

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

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

23. 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

Sponsors and Collaborators

• Ethicon Endo-Surgery

Investigators

• Principal Investigator: Philip R Schauer, M.D, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00721227
• Other Study ID Numbers: CI-07-0005
• First Posted: Jul 24, 2008
• Last Update Posted: Sep 8, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Weight Loss

Study Results

Participant Flow

Recruitment Details	Enrollment period started April 17, 2008. Enrollment continued until December 31, 2008. The followup period continued until January 29, 2010. Enrollment was conducted in the bariatric and research offices of The Cleveland Clinic Foundation, Cleveland, Ohio.

Arm/Group Title	Anterior Curve	Greater Curve
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve
Period Title: Overall Study
STARTED	9	6
COMPLETED	5	6
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Anterior Curve	Greater Curve	Total
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve	Total of all reporting groups
Overall Participants	9	6	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	6 100%	15 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.0 (10.37)	36.8 (8.42)	41.7 (10.19)
Sex: Female, Male (Count of Participants)
Female	6 66.7%	6 100%	12 80%
Male	3 33.3%	0 0%	3 20%
Region of Enrollment (participants) [Number]
United States	9 100%	6 100%	15 100%

Outcome Measures

1. Primary Outcome

Title	Successful Gastric Plication Using Reduction Gastroplasty
Description	The number of participants who completed the study and had post-opeartive gastrocopies showing intact plications.
Time Frame	Immediately post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anterior Curve	Greater Curve
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve
Measure Participants	9	6
Number [participants]	9 100%	6 100%

2. Secondary Outcome

Title	Durability of Gastric Plications Following Reduction Gastroplasty
Description	The number of participants who completed month 12 gastroscopies showing intact plications.
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

Includes only participants who completed month 12 gastroscopy.

Arm/Group Title	Anterior Curve	Greater Curve
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve
Measure Participants	5	6
Number [participants]	4 44.4%	5 83.3%

3. Secondary Outcome

Title	Weight Loss Following Reduction Gastroplasty
Description	Percentage of excess weight loss calculated at 12 months post-surgery. Percentage of excess weight loss is calculated is the difference in baseline and post-surgery weight divided by the difference in baseline weight and ideal body weight multiplied by 100.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Includes only participants who completed month 12 visit.

Arm/Group Title	Anterior Curve	Greater Curve
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve	Reduction Gastroplasty by Gastric Plication on Greater Curve
Measure Participants	5	6
Mean (Standard Deviation) [Percentage of weight loss]	23.30 (24.88)	53.43 (22.67)

Adverse Events

Time Frame	13 months
Adverse Event Reporting Description	AEs were collected from the screening visit until the study completion visit at 1 year post surgery.
Arm/Group Title	Anterior Curve		Greater Curve
Arm/Group Description	Reduction Gastroplasty by Gastric Plication on Anterior Curve		Reduction Gastroplasty by Gastric Plication on Greater Curve
All Cause Mortality
	Anterior Curve		Greater Curve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anterior Curve		Greater Curve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		2/6 (33.3%)
Gastrointestinal disorders
Ecessive Post Operative Vomiting	0/9 (0%)	0	1/6 (16.7%)	1
Hepatobiliary disorders
Acute Cholecystitis	0/9 (0%)	0	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	Anterior Curve		Greater Curve
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100%)		6/6 (100%)
Cardiac disorders
Tachycardia	1/9 (11.1%)	1	0/6 (0%)	0
Congenital, familial and genetic disorders
prokeratosis	0/9 (0%)	0	1/6 (16.7%)	1
Eye disorders
vision blurred	0/9 (0%)	0	1/6 (16.7%)	1
Gastrointestinal disorders
Abdominal Pain	5/9 (55.6%)	5	6/6 (100%)	10
Abdominal discomfort	1/9 (11.1%)	1	0/6 (0%)	0
Abdominal distension	1/9 (11.1%)	1	0/6 (0%)	0
Constipation	2/9 (22.2%)	2	3/6 (50%)	3
Dental caries	1/9 (11.1%)	1	0/6 (0%)	0
Diarrhoea	1/9 (11.1%)	1	0/6 (0%)	0
Gastric ulcer	1/9 (11.1%)	1	0/6 (0%)	0
Vomiting	0/9 (0%)	0	2/6 (33.3%)	2
hiatus hernia	1/9 (11.1%)	1	1/6 (16.7%)	1
nausea	7/9 (77.8%)	7	6/6 (100%)	7
vomiting	0/9 (0%)	0	1/6 (16.7%)	1
General disorders
chest discomfort	1/9 (11.1%)	1	0/6 (0%)	0
early satiety	1/9 (11.1%)	1	0/6 (0%)	0
fatigue	0/9 (0%)	0	1/6 (16.7%)	1
oedema peripheral	0/9 (0%)	0	1/6 (16.7%)	1
pain	1/9 (11.1%)	1	0/6 (0%)	0
Hepatobiliary disorders
hepatic steatosis	1/9 (11.1%)	1	0/6 (0%)	0
Infections and infestations
oral candidiasis	0/9 (0%)	0	1/6 (16.7%)	2
pharyngitis	0/9 (0%)	0	1/6 (16.7%)	1
sinusitis	1/9 (11.1%)	1	1/6 (16.7%)	1
upper respiratory tract infection	0/9 (0%)	0	2/6 (33.3%)	3
urinary tract infection	0/9 (0%)	0	1/6 (16.7%)	1
Injury, poisoning and procedural complications
ankle fracture	1/9 (11.1%)	1	0/6 (0%)	0
burns first degree	0/9 (0%)	0	1/6 (16.7%)	1
limb injury	1/9 (11.1%)	1	0/6 (0%)	0
post procedural haematoma	1/9 (11.1%)	1	0/6 (0%)	0
procedural complication	0/9 (0%)	0	1/6 (16.7%)	1
procedural pain	3/9 (33.3%)	3	0/6 (0%)	0
procedural vomiting	0/9 (0%)	0	1/6 (16.7%)	1
Investigations
blood glucose increased	1/9 (11.1%)	1	0/6 (0%)	0
blood magnesium decreased	0/9 (0%)	0	1/6 (16.7%)	1
Metabolism and nutrition disorders
fluid overload	0/9 (0%)	0	1/6 (16.7%)	1
hypokalaemia	0/9 (0%)	0	1/6 (16.7%)	1
Musculoskeletal and connective tissue disorders
arthralgia	0/9 (0%)	0	1/6 (16.7%)	1
back pain	1/9 (11.1%)	1	1/6 (16.7%)	1
musculoskeletal pain	0/9 (0%)	0	2/6 (33.3%)	3
pain in extremity	1/9 (11.1%)	1	0/6 (0%)	0
rotator cuff syndrome	1/9 (11.1%)	1	0/6 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin papilloma	0/9 (0%)	0	1/6 (16.7%)	1
Nervous system disorders
headache	0/9 (0%)	0	1/6 (16.7%)	1
Psychiatric disorders
anxiety	0/9 (0%)	0	1/6 (16.7%)	1
depression	0/9 (0%)	0	1/6 (16.7%)	1
insomnia	0/9 (0%)	0	1/6 (16.7%)	1
Renal and urinary disorders
nephrolithiasis	0/9 (0%)	0	1/6 (16.7%)	1
Reproductive system and breast disorders
menorrhagia	0/9 (0%)	0	1/6 (16.7%)	1
vulvovaginal pruritus	1/9 (11.1%)	1	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
bronchospasm	1/9 (11.1%)	1	0/6 (0%)	0
nasal septum deviation	1/9 (11.1%)	1	0/6 (0%)	0
nasal turbinate hypertrophy	1/9 (11.1%)	1	0/6 (0%)	0
Skin and subcutaneous tissue disorders
alopecia	1/9 (11.1%)	1	1/6 (16.7%)	1
dermal cyst	0/9 (0%)	0	1/6 (16.7%)	1
rash	1/9 (11.1%)	1	1/6 (16.7%)	1
Vascular disorders
hypertension	3/9 (33.3%)	3	2/6 (33.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.