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Quality of Life After Surgery for End-stage Achalasia

NCT04152902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-11-05

No results posted yet for this study

Summary

Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy.

The study included 31 patients (57 years) who underwent the Heller-Dor procedure with verticalisation of the distal oesophagus (pull-down technique dedicated to sigmoid oesophagus treatment) and 29 patients (recurrence free, 64 years) (p=0.539) who underwent oesophagectomy for end-stage achalasia or for cancer, extracted from a database designed for prospective clinical research. The objective outcomes of treatment were evaluated with semi-quantitative scales investigating dysphagia, reflux symptoms and endoscopic oesophagitis. Quality of life was assessed with the SF-36 questionnaire.

Conditions

  • Symptoms and Signs
  • Quality of Life

Interventions

OTHER

Objective outcome

The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis

OTHER

Quality of life

SF-36 Questionnaire

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1987-01-31
Primary Completion
2018-07-31
Completion
2019-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04152902 on ClinicalTrials.gov