Gastric Plication in Mexican Patients

NCT03210207 | Completed DMC

• 1 other identifier: gastroplicature-2017
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Between January and December 2012, a total of 40 patients underwent GLP. The study will assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60 months.

Conditions

Bariatric Surgery Candidate; Weight Loss; Obesity, Morbid

Outcome Measures

Primary Outcomes (20)

• excess weight loss (%EWL)

  3 postoperative months

• weight loss

  3 postoperative months

• BMI loss

  3 postoperative months

• excess of BMI loss (%BMI)

  3 postoperative months

• %EWL

  6 postoperative months

• %EWL

  12 postoperative months

• %EWL

  36 postoperative months

• %EWL

  60 postoperative months

• weight loss

  6 postoperative months

• weight loss

  12 postoperative months

• weight loss

  36 postoperative months

• weight loss

  60 postoperative months

• BMI loss

  6 postoperative months

• BMI loss

  12 postoperative months

• BMI loss

  36 postoperative months

• BMI loss

  60 postoperative months

• %BMI

  6 postoperative months

• %BMI

  12 postoperative months

• %BMI

  36 postoperative months

• %BMI

  60 postoperative months

Study Arms (1)

GASTROPLICATURE

The procedure begins with division of the greater curve vessels from 4 to 5 cm proximal to the pylorus to the angle of His. Either ultrasonic energy or bipolar cautery is appropriate for this step. 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

Procedure: GASTROPLICATURE

Interventions

GASTROPLICATURE PROCEDURE

All procedures were performed by a single surgeon. All patients underwent 2-row gastric plication. Dissection was started at the greater curvature of the stomach in contact to the gastric wall from prepyloric area to 2-cm proximal to the Hiss angle preserving the anatomy of Hiss angle. All vessels along the greater curvature were separated using LigaSure (Covidien, Mansfield, MA, USA). The greater curvature (from the perimeter) was invaginated using 2 rows of 00 prolene or 00 nylon sutures. Two layers of plication were performed with continuous sutures with 1 surgical sting in all patients to prevent any displacement of inverted folds such as eversion outside or intussusception into esophagus or pylorus. All sutures were extramucusal to avoid their absorption by gastric acid. Finally, a tube shaped stomach was achieved in which the greater curvature was inverted in to the stomach.

GASTROPLICATURE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Mexican patients who underwent Gastroplicature

You may qualify if:

• 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)
• to 50 years
• 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;
• 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;
• HbA1C \< 11%; and
• 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.

You may not qualify if:

• Documented history of drug and/or alcohol abuse within two (2) years of the Screening Visit;
• Previous malabsorptive or restrictive procedures performed for the treatment of obesity;
• Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;
• Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;
• Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring \> 2 medications, or history of suicide attempts;
• 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
• Any condition which precludes compliance with the study, including:
• 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;
• Congenital or acquired anomalies of the GI tract, including atresias or stenosis;
• Severe cardiopulmonary disease or other serious organic disease that makes the subject a high-risk surgical candidate;
• Uncontrolled hypertension;
• Portal hypertension;
• Chronic or acute upper gastrointestinal bleeding conditions (e.g., gastric or esophageal varices);
• Cirrhosis;
• Congenital or acquired intestinal telangiectasia;

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

MeSH Terms

Conditions

Weight Loss; Obesity, Morbid

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 6, 2017
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share