跳至主要内容
临床试验/NCT01178567
NCT01178567已完成不适用

Comparison of Pulmonary Complications Related to Laparoscopic Sleeve Gastrectomy and Laparoscopic Adjustable Gastric Banding

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
1
主要终点
Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding.

研究概览

简要总结

Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding.

详细描述

Obesity is defined as a body mass index (BMI) of more than 30 (1). Its frequency varies according to social, economical and cultural situations. Approximately 15%-20% of the population of Europe, 40% of the United States, and up to 80% of some Native American and Pacific Islands populations (1) are morbidly obese, defined as a BMI more than 39 (2).

The laparoscopic adjustable silicone banding (LAP-BAND) procedure has rapidly gained acceptance and is now considered the most common bariatric operation. In the literature, there are rare case reports about respiratory complications following LAP-BAND. Hofer et al. (3) reported a case of recurrent aspiration pneumonia. Nemni reported a case of chronic cough that was eliminated after LAP-BAND deflation (4). Almoudi reported a case of left lower lobe pneumonia 3 years following LAP-BAND. The patient had presented with asthma-like symptoms (5).

However, there are no studies in the literature addressing long-term pulmonary complications following LAP-BAND. Reports on most previous studies with a medium-term follow-up of 4 years have focused on weight loss as a deciding factor for the success of the surgery, rather than on long-term complications.

Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity (6). Early data suggest LSG is efficacious in the management of morbid obesity and may have an important role either as a staged or definitive procedure. A systematic review of the literature analyzing the clinical and operational outcomes of LSG was completed to further define the status of LSG as an emerging treatment modality for morbid obesity (7). Data from LSG were compared to benchmark clinical data and local operational data from laparoscopic adjustable gastric band (LAP-BAND) and laparoscopic gastric bypass (LRYGB) procedures.

A systematic review of the literature identified 15 studies (940 patients). The percent excessive weight loss (%EWL) for LSG varied from 33% to 90% and appeared to be sustained up to 3 years. The mortality rate was 0-3.3% and major complications ranged from 0% to 29% (average 12.1%). Operative time ranged from 49 to 143 min (average 100.4 min). Hospital stay varied from 1.9 to 8 days (average 4.4 days).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who paste surgery in Meir Hospital included with stomach ring and sleeve surgery.

排除标准

  • Patients who underwent other bariatric surgery in the past will excluded

结局指标

主要结局

Comparison of Pulmonary Complications related to laparoscopic sleeve gastrectomy and laparoscopic adjustable gastric banding.

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验