Pneumatic Dilatation or Surgical Myotomy for Achalasia

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02086669
• Collaborator: Sahlgrenska University Hospital, Sweden (Other)
• Enrollment: 56
• Location: 1
• Arms: 2
• Duration (Months): 168
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

Condition or Disease	Intervention/Treatment	Phase
Achalasia	Procedure: Pneumatic dilatation; Procedure: Laparoscopic myotomy	Phase 2

Detailed Description

Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures.

Health Related Quality of Life (HRQL) has been regularly checked.

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up
• Study Start Date: Jan 1, 2000
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pneumatic dilatation Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.	Procedure: Pneumatic dilatation
Active Comparator: Surgical myotomy Laparoscopic myotomy and subsequent follow up.	Procedure: Laparoscopic myotomy

Outcome Measures

Primary Outcome Measures

1. Treatment failures [At least five years after intervention]

   Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes.

Secondary Outcome Measures

1. Dysphagia scoring [At least five years after intervention]

   Dysphagia score according to standardized, validated scoring system.

2. Health Related Quality of Life [At least five years after intervention.]

   Universally adopted and validated instruments are used.

3. Direct medical costs. [At least five years after intervention.]

   Charges for the average hospital in respective countries.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Newly diagnosed achalasia

• Age 18-80 years

• Informed consent

Exclusion Criteria:

• Previous treatment for achalasia.

• Stage IV achalasia.

• Unwillingness to participate.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Göteborg		Sweden	41132

Sponsors and Collaborators

• Karolinska University Hospital
• Sahlgrenska University Hospital, Sweden

Investigators

• Study Chair: Lars Lundell, Professor, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT02086669
• Other Study ID Numbers: S500-00
• First Posted: Mar 13, 2014
• Last Update Posted: Apr 5, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Esophageal Achalasia

Study Results

No Results Posted as of Apr 5, 2016