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Trials / Completed

CompletedNCT03210207

Gastric Plication in Mexican Patients

Laparoscopic Gastric Plication: 5 Years of Follow-up in Mexican Patients

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Instituto Mexicano del Seguro Social · Other Government
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

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.

Detailed description

The patient characteristics extracted from the medical records included age and gender. A detailed height and weight history was collected to reflect BMI, excess weight, %EWL, and %BMI before LGP and after 3, 6, 12, 36 and 60 months. The institutional review board approved the present study.

Conditions

Interventions

TypeNameDescription
PROCEDUREGASTROPLICATUREAll 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.

Timeline

Start date
2016-09-01
Primary completion
2017-03-01
Completion
2017-04-01
First posted
2017-07-06
Last updated
2017-07-12

Source: ClinicalTrials.gov record NCT03210207. Inclusion in this directory is not an endorsement.