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临床试验/NCT03438838
NCT03438838Unknown不适用

Randomised Clinical Trial Comparing Relief of Dysphagia Between Laparoscopic Heller's Myotomy Alone Versus Laparoscopic Heller's Myotomy With Anterior Fundoplication In Achalasia Cardia-A Pilot Study

Govind Ballabh Pant Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Frequency of Dysphagia

研究概览

简要总结

Back ground: Achalasia Cardia (AC) manifests with major symptom dysphagia. Surgery as the treatment modality relieves dysphagia in most of the patients. Laparoscopic Heller's myotomy(LHM) is the surgery of choice but is associated with gastroesophageal reflux. Anterior fundoplication (Dor Fundoplication) is usually combined with LHM in patients with AC. It reduces gastroesophageal reflux following LHM. It has been observed that along with reduction of gastroesophageal reflux Dor Fundoplication also affects relief of dysphagia. But it has not been prospectively studied.

Hypothesis:The hypothesis of present study is that "Frequency of dysphagia following Laparoscopic Heller's myotomy with Dor fundoplication is more than that compared to Laparoscopic Heller's myotomy alone in patients with Achalasia Cardia".

Methods: From December2017 to November 2018 minimum of 20 patients with diagnosis of Achalasia cardia will be randomized to receive either Laparoscopic Heller's myotomy (LHM) alone or LHM with Dor fundoplication. Symptomatic outcomes would be assessed using frequency of dysphagia and Eckardt's score. .

Outcomes: Primary outcome is Frequency of dysphagia and secondary outcome is manometry pressure assessment. Statistical analysis would be done using Statistical Package for the Social Sciences (SPSS) soft ware. P value < 0.05 is considered significant.

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)

盲法说明

Patients will be randomized using computer generated table of random numbers contained in a sealed opaque envelope to be opened in operation theatre after induction anesthesia.

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

  • All adult patients (18 years or more) with Achalasia cardia

排除标准

  • Patients of achalasia with axis deviation
  • Patients with history of pneumatic dilatation
  • Patient with other associated motility or non motility disorders
  • Patients with pseudoachalasia Prior gastric or esophageal surgery

结局指标

主要结局

Frequency of Dysphagia

时间窗: Minimum one month after surgery

None- 0 Occasional-1 Daily-2 Each meal-3

次要结局

  • Manometry pressure(Minimum one month after surgery)
  • Gastro esophageal reflux(Minimum after one month)
  • Eckardt's score(Minimum after one month)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hirdaya H Nag, MS

Dr. Prof

Govind Ballabh Pant Hospital

研究点 (2)

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