NCT07344935已完成不适用
Evaluation of the Effectiveness of the Ezisurg Stapling (Ezi Endo Lite) During Laparoscopic Nissen Sleeve Gastrectomy
Ezisurg Medical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2022年1月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- The rate of patients with GERD at 24 months
研究概览
简要总结
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) ≥ 30 kg/m² (or BMI ≥ 27 kg/m² with at least one obesity-related comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia).
- •Medically eligible for laparoscopic sleeve gastrectomy (LSG) or Nissan sleeve surgery, as determined by a multidisciplinary bariatric team (e.g., surgeon, endocrinologist, dietitian).
- •Ability to understand and voluntarily sign written informed consent.
- •Willingness to comply with post-operative follow-up protocols (e.g., dietary monitoring, clinical visits, laboratory tests).
排除标准
- •BMI < 30 kg/m² (or < 27 kg/m² without obesity-related comorbidities).
- •Contraindications to laparoscopic surgery (e.g., severe abdominal adhesions, hemodynamic instability, uncorrected coagulopathy).
- •History of major gastrointestinal surgery (e.g., gastric bypass, colectomy) or anatomical abnormalities precluding sleeve gastrectomy.
- •Active or uncontrolled chronic diseases (e.g., end-stage renal disease, cirrhosis, metastatic cancer, severe cardiovascular disease).
- •Psychiatric disorders limiting adherence to post-operative care (e.g., severe depression, psychosis, substance use disorder).
- •Pregnancy or breastfeeding (or plans for pregnancy within 12 months post-surgery).
- •Allergy or intolerance to surgical materials, anesthesia, or post-operative medications required for the study.
- •Inability to communicate or cooperate with study procedures (e.g., language barriers, cognitive impairment).
结局指标
主要结局
The rate of patients with GERD at 24 months
时间窗: 24 months
The main objective of the study was to evaluate the impact of Sleeve Gastrectomy procedure with a Nissen fundoplication (Nissen-Sleeve) on the rate of patients with GERD at 24 months.
次要结局
- Surgery time(Perioperative/Periprocedural)
- Intra-operation incidents(Perioperative/Periprocedural)
- Hospital stays(Perioperative/Periprocedural)
- Rate of re-intervention(two-year)
- Rate of re-hospital(two-year)
- One-year Endoscopy finding(One-year)
- Early & Long term post-operative complication(two-year)
研究者
研究点 (1)
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