Quality of Life After POEM for Achalasia

Esophageal Achalasia Clinical Trial

Official title:

Health-Related Quality of Life After Peroral Endoscopic Myotomy for Patients With Achalasia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05010889
• Other study ID #: 124
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiangbin Xing, MD, PhD
• Phone: +862087755766
• Email: xxbken[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Achalasia is an esophageal motility disorder, characterized by insufficient lower esophageal sphincter relaxation and loss of esophageal peristalsis. Patients with achalasia experience distressing gastrointestinal symptoms, including dysphagia, reflux and chest pain, which lead to weight loss and malnutrition. Undoubtedly, health-related quality of life can be significantly diminished in patients with achalasia. At present, POEM has become one of the standard therapies for achalasia. Limited studies have focused on the patient's quality of life before and after POEM. The present study aimed to assess the changes in quality of life of patients with achalasia using the validated achalasia severity questionnaire (ASQ) and the short form (SF)-36 scale.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy

• Scheduled to undergo POEM for treatment of achalasia

Exclusion Criteria:

• Coagulopathy and systemic disorders that precluded safe general anesthesia

Related Conditions & MeSH terms

• Esophageal Achalasia

Intervention

Procedure:
• Peroral 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Change from Baseline ASQ score at 3 months and 12 months after treatment
Primary	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).	Baseline, Change from Baseline SF-36 score at 3 months and 12 months after treatment
Secondary	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).	baseline, 3 months and 12 months after treatment
Secondary	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).	baseline, 3 months and 12 months after treatment
Secondary	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).	3 months after treatment