Short Versus Long Submucosal Tunneling in Per-oral Endoscopic Myotomy (POEM) for Type II Achalasia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change from baseline eckardt score at 3 months
研究概览
简要总结
this study is prospective , randomized and interventional ,will be performed on 50 patients to compare the clinical utility , safety profile and postoperative recovery metrics between short and long per-oral endoscopic myotomy , patients will be divided randomly into two equal groups one will do short myotomy and the other group will do long myotomy , each group will contain 25 patients methodology &patient selection : patients follow the inclusion criterias including :
- Patients of all ages were eligible for inclusion in the study with no upper or lower age limits applied .
- Both sexes are included .
- Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) >15 mmHg ).
- Eckardt score >3 ( moderate to severe symptoms). this study aims to compare the outcomes of short versus long esophageal myotomy in cases with type II achalasia using Eckardt score and barium study at 3 month follow up. also to evaluate difference in length of the opearation , intra-operative and post-operative adverse events between short and long submucosal tunneling.
every patient will do upper endoscopy and manometry preoperative , also ekcardt score will be caculated , follow up after 3 months by barium swallow and eckardt score
详细描述
Aim of the study :
Primary outcome :
to compare the outcomes of short versus long esophageal myotomy in cases with type II achalasia using Eckardt score and barium study at 3 month follow up.
to evaluate difference in length of the opearation , intra-operative and post-operative adverse events between short and long submucosal tunneling.
Secondary outcome :
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all ages were eligible for inclusion in the study with no upper or lower age limits applied .
- •Both sexes are included .
- •Type II achalasia patients who are diagnosed by High Resolution. Manometry based on Chicago Classification (v4.0) characterized by (failed esophageal peristalsis , pan-esophageal pressurization in ≥20% of swallows and Integrated Relaxation Pressure (IRP) >15 mmHg ).
- •Eckardt score >3 ( moderate to severe symptoms
排除标准
- •Type I ,type III achalasia & Non-achalasia spastic motility disorders.
- •Sigmoid type esophagus (diameter> 6 cm ).
- •Esophageal diverticulae .
- •Presence of large Hiatus Hernia ( >5cm).
- •Severe erosive esophagitis (La Grade C or D) or Barrett's Esophagus.
- •History of previous Heller's myotomy.
- •Pseudoachalasia due to underlying malignancy.
- •Severe coagulopathy ( INR>1.5 or platelets <50000 ).
结局指标
主要结局
change from baseline eckardt score at 3 months
时间窗: 3 months postoperatively
the eckardt score is a clinical grading for achalasia evaluating four symtoms dysphagia , regurgitation , retrosternal pain and weight loss ( each scored 0to3 , total score ranges from 0 to 12 where higher scores indicate severe symtoms
postoperative barium column height at 3 months
时间窗: 3 month postoperatively
evaluation of esophageal emptying by measuring the height of timed barium in centimeters at 1,2and 5 minutes during the barium swallow
total operative operation
时间窗: during the operation (from incision to closure )
total time taken to complete the procedure , measured in minutes from initial mucosal incision to final closure
incidence of intraoperative adverse events
时间窗: during the operation
number of participants who experience intraoperative complications such as mucosal perforation or significant hemorrhage during submucosal tunneling
post-operative complications
时间窗: from the completion of operation upto the hospital discharge ( within 48 hr)
number of participants experiencing post-operative complications ( e.g delayed bleeding , infection,or leakage )
次要结局
- length of hospital stay(from day of the procedure until the day of official hospital discharge)
- incidence of post-operative reflux esophagitis(3 months postoperatively)
研究者
Omar Mohamed Magdy Eid
assistant lecturer of internal medicine
Assiut University