Pneumatic Dilatation or Surgical Myotomy for Achalasia

NCT ID: NCT02086669

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Achalasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pneumatic dilatation

Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence.

Group Type EXPERIMENTAL

Pneumatic dilatation

Intervention Type PROCEDURE

Surgical myotomy

Laparoscopic myotomy and subsequent follow up.

Group Type ACTIVE_COMPARATOR

Laparoscopic myotomy

Intervention Type PROCEDURE

Interventions

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Pneumatic dilatation

Intervention Type PROCEDURE

Laparoscopic myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed achalasia
* Age 18-80 years
* Informed consent

Exclusion Criteria

* Previous treatment for achalasia.
* Stage IV achalasia.
* Unwillingness to participate.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lundell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Lundell, Professor

Role: STUDY_CHAIR

Karolinska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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Persson J, Johnsson E, Kostic S, Lundell L, Smedh U. Treatment of achalasia with laparoscopic myotomy or pneumatic dilatation: long-term results of a prospective, randomized study. World J Surg. 2015 Mar;39(3):713-20. doi: 10.1007/s00268-014-2869-4.

Reference Type DERIVED
PMID: 25409838 (View on PubMed)

Other Identifiers

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S500-00

Identifier Type: -

Identifier Source: org_study_id

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