Comparative Study Between the Effect of Nissen Fundoplication and Toupet Fundoplication on Post Operative Manometry Findings A Randomized Control Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Lower Esophageal Sphincter (LES) Resting Pressure
研究概览
简要总结
This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disease (GERD). The study, conducted at Ain Shams University Hospitals, involved 20 adult patients randomly assigned to undergo either procedure. Preoperative and postoperative high-resolution manometry (HRM) was used to assess lower esophageal sphincter (LES) pressure and esophageal motility.
详细描述
Preoperative Setting:
Before surgery, all patients underwent a thorough clinical assessment to evaluate the severity of their GERD symptoms, history of medication use, and the presence of extra-esophageal manifestations such as chronic cough or aspiration. A comprehensive diagnostic workup was conducted, including upper gastrointestinal endoscopy to assess mucosal integrity, rule out Barrett's esophagus, and evaluate the presence of a hiatal hernia. A barium swallow study was performed to assess esophageal motility, reflux severity, and anatomical abnormalities. The cornerstone of preoperative evaluation was high-resolution manometry (HRM), which provided precise measurements of lower esophageal sphincter (LES) pressure, esophageal peristalsis, and overall esophagogastric junction function.
Patients were deemed eligible for the study if they were between 18 and 65 years old and had documented low LES pressure on HRM. Those with persistent GERD symptoms despite at least 12 weeks of maximal medical therapy, intolerance to medication, or a desire to avoid lifelong proton pump inhibitor (PPI) therapy were considered suitable candidates. To ensure adequate postoperative esophageal motility, only patients with at least 30% esophageal peristalsis were included. Patients with esophageal motility disorders (such as achalasia), morbid obesity (BMI >35 kg/m²), a history of upper abdominal surgery, or a severely shortened esophagus were excluded. Patients classified as ASA III, IV, or V were also excluded due to the increased surgical risks associated with poor general health.
Patients were required to fast for at least 6-8 hours before surgery to minimize aspiration risk. Routine preoperative laboratory investigations, including a complete blood count (CBC), coagulation profile, and liver and kidney function tests, were performed. All patients underwent a pre-anesthesia assessment to determine their fitness for general anesthesia. On the day of surgery, prophylactic intravenous antibiotics were administered.
Intraoperative Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adult patients between 18 and 65 years of age
- •Patients with pre-operable low LES pressure proven by High resolution manometry.
- •Patients refractory to medical therapy: Persistent symptoms after 12 weeks of maximal medical therapies, recurrence upon cessation of medications.
- •Patients who are non-compliance with medical therapies or inability to tolerate medical therapies .
- •Patients with esophageal motility more than 30%
排除标准
- •Patients with esophageal motility less than 30%.
- •Patent with morbidly obese (BMI more than 35 kg/m2),
- •Patients with recent upper abdominal surgery or severely shortened esophagus
- •Extremes of age less than 18 and more than
- •Patients who are unfit for general anesthesia (ASAIII,IV or V)..
研究组 & 干预措施
N GROUP
Patients undergoing laparoscopic Nissen fundoplication (LNF), which involves a 360° total wrap of the gastric fundus around the esophagus.
干预措施: Laparoscopic Nissen Fundoplication (Procedure)
T group
Patients undergoing laparoscopic Toupet fundoplication (LTF), which involves a 270° posterior partial wrap of the gastric fundus around the esophagus.
干预措施: Laparoscopic Toupet fundoplication (Procedure)
结局指标
主要结局
Lower Esophageal Sphincter (LES) Resting Pressure
时间窗: 6 Weeks Postoperative
LES resting pressure will be recorded using high-resolution manometry (HRM) at 6 weeks after surgery to quantify baseline LES tone restoration. Unit of Measurment : mm Hg
次要结局
未报告次要终点
