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Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Primary Purpose

Obesity

Status

Unknown status

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Laparoscopic Vertical Gastroplasty

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric, Surgery, Sleeve, Gastroplasty, Laparoscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician
BMI>40
BMI>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year
Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method;
No previous bariatric procedure
Informed consent given by patient

Exclusion Criteria:

Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure
Psychological-Psychiatric (boulimia, severe depression, psychotic condition)
Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition
Unability to understand goal of the study, plan of treatment and follow-up
Large hiatal hernia and/or severe esophageal reflux disease
Grazer, Sweet eater behavior

Sites / Locations

Dept of Abdominal Surgery and Transplantation, CHU Liège

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic Vertical Gastroplasty

Arm Description

Outcomes

Primary Outcome Measures

Morbidity/Mortality

Effect of the procedure on weight loss

Evaluation at 1,3,6 and 12 months through clinical evaluation.

Secondary Outcome Measures

Reflux disease

Evaluation at 1,3,6 and 12 months through clinical evaluation, Gastroscopy if symptoms present. Upper GI opacification at one year will be performed for all patients.

Effect of procedure on obesity associated co-morbidities

Co-morbidities include diabetes, hypertension, sleep apnea syndrome, dyslipemia Evaluation at 1,3,6 and 12 months through clinical evaluation and blood assessment

Full Information

NCT ID

NCT02050477

First Posted

January 25, 2014

Last Updated

January 28, 2014

Sponsor

University of Liege

1. Study Identification

Unique Protocol Identification Number

NCT02050477

Brief Title

Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

Official Title

Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Liege

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients

Detailed Description

The laparoscopy is performed under general anesthesia with a 5 ports access under 14mm Hg pressure. After opening of the gastrocolic ligament and division of any adhesions between stomach and pancreas a circular opening is performed at the junction of corpus and antrum of the stomach with a circular stapler. A tubular gastric pouch is then created along a calibration tube at the lesser curvature by a vertical stapling starting from the circular opening to the angle of Hiss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Bariatric, Surgery, Sleeve, Gastroplasty, Laparoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laparoscopic Vertical Gastroplasty

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic Vertical Gastroplasty

Intervention Description

The Magenstrasse and Mill procedure is a conservative vertical gastroplasty described in 1987 through a laparotomy. A tubular gastric pouch is created by a vertical stapling extending from the antrum to the angle of Hiss. In this study, we evaluate the laparoscopic technique of the procedure.

Primary Outcome Measure Information:

Title

Morbidity/Mortality

Time Frame

1 month

Title

Effect of the procedure on weight loss

Description

Evaluation at 1,3,6 and 12 months through clinical evaluation.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Reflux disease

Description

Evaluation at 1,3,6 and 12 months through clinical evaluation, Gastroscopy if symptoms present. Upper GI opacification at one year will be performed for all patients.

Time Frame

1 year

Title

Effect of procedure on obesity associated co-morbidities

Description

Co-morbidities include diabetes, hypertension, sleep apnea syndrome, dyslipemia Evaluation at 1,3,6 and 12 months through clinical evaluation and blood assessment

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician BMI>40 BMI>35 with diabetes or sleep apnea syndrome or hypertension treated with 3 drugs for at least one year Male or female patients between 18 and 75 years of age; fertile female patients must use a reliable contraception method; No previous bariatric procedure Informed consent given by patient Exclusion Criteria: Medical contra-indication for a general anesthesia, or abdominal surgery (allergies to anesthetic drugs, cardio-vascular, pulmonary, or renal conditions leading to an unacceptable risk for the procedure Psychological-Psychiatric (boulimia, severe depression, psychotic condition) Non stabilized endocrine disorder, with potential interference on weight and/or diabetic condition Unability to understand goal of the study, plan of treatment and follow-up Large hiatal hernia and/or severe esophageal reflux disease Grazer, Sweet eater behavior

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaud De Roover, MD

Organizational Affiliation

Dept of Abdominal Surgery and Transplantation CHU Liège Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Abdominal Surgery and Transplantation, CHU Liège

City

Liège

ZIP/Postal Code

4000

Country

Belgium

12. IPD Sharing Statement

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Clinical Study of Laparoscopic Non Banded Vertical Gastroplasty in Bariatric Surgery

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