Quality of Life After POEM for Achalasia

Browse trials for

• Esophageal Achalasia 140

Keywords

• Esophageal Achalasia, Peroral Endoscopic Myotomy, Quality of Life

Esophageal Achalasia

140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

This study's planned enrollment of 200 is above the median of 111 across 41 observational studies indexed under Esophageal Achalasia.

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Study population

Groups and cohorts

• Achalasia patients

  Patients schedule to undergo POEM for treatment of symptomatic achalasia. The diagnosis of achalasia was based on high resolution manometry, barium esophagram, and upper endoscopy.

  Procedure: Peroral endoscopic myotomy (POEM)

Interventions

• ProcedurePeroral endoscopic myotomy (POEM)

  POEM is performed as previously described by Inoue et al (Endoscopy 2010), including four main steps mucosal incision, submucosal tunneling, myotomy and mucosal entry closure.

Primary outcomes

1. Achalasia symptom questionnaire (ASQ)

   Achalasia symptom questionnaire assess the disease-specific health-related quality of life by sampling the concepts of food tolerance, dysphagia-related behavior modifications, pain, heartburn, distress, lifestyle limitation, and satisfaction in 10 items. The total range is 10 to 31, with higher scores indicating worse quality of life (Urbach et al, Am J Gastroenterol 2005).

   Time frame: Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment

2. Short form (SF)-36

   The short form (SF)-36 (best score 100, worst score 0). The short form (SF)-36 assess the health-related quality of life from 8 aspects, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health in 36 items. The total range is 0 to 100, with lower scores indicating worse quality of life (Ware et al, J Clin Epidemiol 1998).

   Time frame: Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment

Secondary outcomes

1. Eckardt score

   The Eckardt score assesses the severity of achalasia symptoms by combining the sum of symptom frequency scores for dysphagia, regurgitation, and chest pain and a weight loss score. Each component can be graded from 0 to 3 points. The total range is 0 to 12, with higher scores indicating more severe symptoms (Eckardt AJ et al, Nat Rev Gastroenterol Hepatol 2011).

   Time frame: baseline, 3 months and 12 months after treatment

2. Gastroesophageal reflux disease questionnaire (GerdQ) score

   The GerdQ has been developed as a tool to facilitate the symptom-based diagnosis of GERD. Scores ranging from 0 to 3 were applied for the four positive predictors (heartburn, regurgitation, sleep disturbance due to reflux symptoms and use of over-the-counter medications for reflux symptoms) and from 3 to 0 for two negative predictors (epigastric pain and nausea). The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. A total GerdQ score \>7 is considered indicative of significant GERD symptoms (Jones R et al, Aliment Pharmacol Ther 2009).

   Time frame: baseline, 3 months and 12 months after treatment

3. Reflux esophagitis on post-POEM endoscopy

   The severity of reflux esophagitis is graded according to the Los Angeles classification (Armstrong D et al, Gastroenterology 1996).

   Time frame: 3 months after treatment

Individual participant data

Plan to share: No