Laparoscopic Non Banded Vertical (Magenstrasse and Mill) Gastroplasty In Bariatric Surgery. Morbidity and Results on Weight Loss and Associated Co-morbidities
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Morbidity/Mortality
研究概览
简要总结
Evaluation of the laparoscopic approach of the Magenstrasse and Mill procedure in a prospective study of 100 patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Assessment by a multidisciplinary team specialized in bariatric and metabolic surgery including surgeon, endocrinologist, psychologist and/or psychiatrist, dietician
- •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
排除标准
- •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
结局指标
主要结局
Morbidity/Mortality
时间窗: 1 month
Effect of the procedure on weight loss
时间窗: 1 year
Evaluation at 1,3,6 and 12 months through clinical evaluation.
次要结局
- Effect of procedure on obesity associated co-morbidities(1 year)
- Reflux disease(1 year)
研究者
Arnaud De Roover
Professeur de Clinique, Chef de Clinique
University of Liege