A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia

This study has been completed.
Sponsor:
Collaborator:
Ersta Hospital, Sweden
Information provided by (Responsible Party):
Lars Lundell, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01933373
First received: June 19, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with an increased pressure of the esophageal sphincter. This leads to impairment to swallow and heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal muscle layer extending over to the gastroesophageal junction is the treatment of choice for achalasia. In order to prevent reflux of stomach content into the esophagus this has to be combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped around the esophagus (fundoplication). This procedure can be performed with the wrapped fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter introduces an angulation of the esophagus, which possibly may lead to an impairment of swallowing ability and passage of food to the stomach. On the other hand, the Toupet procedure may give a better control of reflux. The primary endpoint of the study is symptoms of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH measurements in the esophagus), radiological imaging of swallowing and quality of life.


Condition Intervention
Achalasia
Procedure: Toupet
Procedure: Dor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Dysphagia symptoms according to Eckhardt [ Time Frame: up to five years follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory esophageal PH [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]
  • Health-related quality of life according to Velanovich [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]
  • Timed barium esophagogram at 1, 2 and 5 minutes [ Time Frame: One and five years follow up ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2007
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Toupet
Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.
Procedure: Toupet
Laparoscopic posterior partial fundoplication plus myotomy.
Other Name: Laparascopic posterior partial fundoplication plus myotomy.
Experimental: Dor
Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.
Procedure: Dor
Anterior partial fundoplication plus myotomy.
Other Name: Anterior partial fundoplication plus myotomy.

Detailed Description:

By the end of 2012 40 patients have been enrolled and passed the one year follow up.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >18 years of age
  • Typical achalasia according to manometry
  • Eckhardt score >3
  • Informed consent

Exclusion Criteria:

  • Severe comorbidity precluding surgery
  • Pseudo achalasia
  • Inability to participate in follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933373

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Ersta Hospital, Sweden
Investigators
Principal Investigator: Lars R Lundell, Professor Gastrocentrum Karolinska University Hospital, Stockholm Sweden
  More Information

No publications provided

Responsible Party: Lars Lundell, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01933373     History of Changes
Other Study ID Numbers: 2007/595-32
Study First Received: June 19, 2013
Last Updated: August 30, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Randomized
Toupet
Dor
Achalasia

Additional relevant MeSH terms:
Esophageal Achalasia
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 30, 2014