Quality of Life After POEM for Achalasia

NCT05010889 | Unknown

• 1 other identifier: 124
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Achalasia

Keywords

Esophageal Achalasia, Peroral Endoscopic Myotomy, Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Eckardt score

  baseline, 3 months and 12 months after treatment

• Gastroesophageal reflux disease questionnaire (GerdQ) score

  baseline, 3 months and 12 months after treatment

• Reflux esophagitis on post-POEM endoscopy

  3 months after treatment

Study Arms (1)

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

Peroral endoscopic myotomy (POEM) PROCEDURE

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.

Achalasia patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients schedule to undergo POEM for treatment of symptomatic achalasia in one tertiary hospital.

You may qualify if:

• Diagnosed as achalasia base on high resolution manometry, barium esophagram and upper endoscopy
• Scheduled to undergo POEM for treatment of achalasia

You may not qualify if:

• Coagulopathy and systemic disorders that precluded safe general anesthesia

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xiangbin Xing, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Xiangbin Xing, MD, PhD

CONTACT

+862087755766; xxbken@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)