The Effect of Residual Gastric Antrum Size During Laparoscopic Sleeve Gastrectomy in Reducing Postoperative Gastrointestinal Symptoms: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- The incidence rate of upper gastrointestinal symptoms after surgery
研究概览
简要总结
This is a prospective cohort study, which subjects were obese patients requiring LSG surgery. LSG with different gastric resection starting points (2-4cm/4-6 cm from pylorus) as intervention method. The main observation is the incidence and extent of upper gastrointestinal symptoms (such as nausea, vomiting, retching, reflux, difficulty swallowing, etc.).In addition, secondary observations include the excess weight loss (%EWL) and postoperative complications. Aim to investigate the effects of LSG surgery in different starting points of gastric resection on postoperative upper gastrointestinal symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were accepted for surgery if they satisfied the guidelines of the Society of Chinese Gastroenterological Surgeons [body mass index (BMI) ≥40 kg/m2 or BMI ≥35 kg/m2 with at least one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea), age between 18 and 60 years, and failure of conservative treatment over 2 years].
- •All patients undergo preoperative upper gastrointestinal (GI) endoscopy.
排除标准
- •any patient who had previously been submitted to any type of bariatric surgery;
- •patient currently taking anti-nausea or GERD medications preoperatively;
- •any current smokers；
- •active duodenal/gastric ulcer disease；
- •difficult to treat gastroesophageal reflux disease (GERD) with a large hiatal hernia；
- •previous major gastrointestinal surgery；
- •diagnosed or suspected malignancy；
- •poorly controlled significant medical or psychiatric disorders；
- •disorders such as a medical history of major pathology;
- •can not be able to understand and willing to participate in this registry with signature.
结局指标
主要结局
The incidence rate of upper gastrointestinal symptoms after surgery
时间窗: 1 year after surgery
We use three scales to evaluate the incidence of upper gastrointestinal symptoms,include the Chinese translation of R-INVR(the Index of Nausea, Vomiting, and Retching)、EAT-10(Validity and Reliability of the Eating Assessment Tool) and GIS(GERD impact serve).These three scales describe postoperative upper gastrointestinal symptoms,which include vomiting, dysphagia,and acid reflux,heartburn.We focus on the incidence rate of the above symptoms in one year after surgery during 1 year. Visit: Post-op 12 months Visit(±7 Days)
次要结局
- the rate of postoperative complications after surgery(1 year after surgery)
- The excess weight loss (%EWL) after surgery(1 year after surgery)
- The extent of upper gastrointestinal symptoms after surgery(1 year after surgery)
研究者
Zhongtao Zhang
Director of general surgery, principal investigator
Beijing Friendship Hospital