Modifications to Gastric Tube Construction in Vertical Gastrectomy: Implications for Gastroesophageal Reflux Disease and Patient Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence of de novo Gastroesophageal Reflux Disease (GERD)
研究概览
简要总结
This is a prospective randomized clinical trial evaluating the impact of antrum and fundus calibration during laparoscopic vertical gastrectomy (VG) on postoperative gastroesophageal reflux disease (GERD), quality of life, and surgical costs. Eligible participants are adults with morbid obesity (BMI ≥35 kg/m²) undergoing LSG. Patients are randomized into four groups based on whether antral and/or fundal calibration is performed. Primary outcomes include the incidence of de novo GERD at 12 months. Secondary outcomes include postoperative quality of life, vomiting , surgical complications, weight loss, and operative costs. The study aims to optimize the LSG technique by identifying anatomical modifications that minimize GERD while improving clinical outcomes
详细描述
This is a prospective, randomized clinical trial conducted at the Regional University Hospital of Málaga. The objective is to evaluate the effect of antrum and fundus calibration during vertical gastrectomy (VG) on the incidence of gastroesophageal reflux disease (GERD), quality of life, weight loss, and surgical costs.
Eligibility Criteria:
Inclusion criteria include adults with an indication for VG, a body mass index (BMI) ≥ 35 kg/m², and provision of written informed consent.
Exclusion criteria include endocrine-related obesity, active gastrointestinal disease (such as GERD, esophagitis, peptic ulcer, or motility disorders), or a history of gastric surgery.
Randomization and Study Arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with morbid obesity on the waiting list for bariatric surgery.
- •Both male and female participants.
- •Age between 18 and 65 years.
- •BMI > 35 kg/m².
- •Availability to attend scheduled follow-up visits.
- •Indication for sleeve gastrectomy as the first bariatric procedure.
排除标准
- •Obesity of endocrine origin.
- •Preoperative GERD (diagnosed by pH-metry or upper endoscopy following a positive GERD-HRQL test).
- •Active gastrointestinal disease (such as esophagitis, peptic ulcer, cancer, or esophageal motility disorder), diagnosed by endoscopy or manometry.
- •History of previous gastric surgery.
- •Patients not meeting the inclusion criteria
结局指标
主要结局
Incidence of de novo Gastroesophageal Reflux Disease (GERD)
时间窗: 12 months postoperatively
De novo GERD will be diagnosed if any of the following criteria are met: Presence of esophagitis according to the Los Angeles classification DeMeester index \> 14.72 Acid exposure time \> 4% on 24-hour pH-metry GERD-HRQL questionnaire score ≥ 12
次要结局
- Incidence of Postoperative Vomiting(12 months postoperatively)
- Incidence of Postoperative Regurgitation(12 months postoperatively)
- Food intake volume per meal(12 months postoperatively)
- Percentage of excess weight loss (%EWL)(12 months postoperatively)
- Change in Hypertension Status from Baseline to 12 Months Post-Surgery(Baseline and within 12 months after surgery)
- Postoperative BMI(Within 12 months after surgery)
- Weight loss(Within 12 months after surgery)
- Postoperative Morbidity(Up to 30 days after surgery)
- Number of stapler cartridges used(During the surgical procedure)
- Intraoperative complications(During the surgical procedure)
- Change in Type 2 Diabetes Mellitus Status from Baseline to 12 Months Post-Surgery(Baseline and within 12 months after surgery)
- Change in Hypercholesterolemia Status from Baseline to 12 Months Post-Surgery(Baseline and within 12 months after surgery)
- Change in Obstructive Sleep Apnea Syndrome (OSAS) Status from Baseline to 12 Months Post-Surgery(Baseline and within 12 months after surgery)
- Change in Hypertriglyceridemia Status from Baseline to 12 Months Post-Surgery(Baseline and within 12 months after surgery)
- Change in Postoperative Satiety Over Time(2 weeks, 3 months, 6 months, and 12 months postoperatively)
- Tolerance to Oral Liquid Intake After Surgery(2 weeks, 3 months, 6 months, and 12 months postoperatively)
- Tolerance to Oral Solid Intake After Surgery(2 weeks, 3 months, 6 months, and 12 months postoperatively)
- Tolerance to Oral Meat Intake After Surgery(2 weeks, 3 months, 6 months, and 12 months postoperatively)
研究者
Julen Ramon Rodríguez
Principal Investigator
Hospital San Juan de Dios Tenerife