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

NCT01933373 | Completed

• 1 other identifier: 2007/595-32
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia

Keywords

Randomized; Toupet; Dor; Achalasia

Outcome Measures

Primary Outcomes (1)

• Dysphagia symptoms according to Eckhardt

  up to five years follow up

Secondary Outcomes (3)

• Ambulatory esophageal PH

  One and five years follow up

• Health-related quality of life according to Velanovich

  One and five years follow up

• Timed barium esophagogram at 1, 2 and 5 minutes

  One and five years follow up

Study Arms (2)

Toupet

ACTIVE COMPARATOR

Laparoscopic Myotomy + Toupet 180 degree partial posterior fundoplication.

Procedure: Toupet

Dor

EXPERIMENTAL

Laparoscopic Myotomy + Dor anterior partial fundoplication. 90 degree partial fundoplication being the standard of care.

Procedure: Dor

Interventions

Toupet PROCEDURE

Laparoscopic posterior partial fundoplication plus myotomy.

Also known as: Laparascopic posterior partial fundoplication plus myotomy.

Toupet

Dor PROCEDURE

Anterior partial fundoplication plus myotomy.

Also known as: Anterior partial fundoplication plus myotomy.

Dor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe comorbidity precluding surgery
• Pseudo achalasia
• Inability to participate in follow-up

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Ersta Hospital, Sweden: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (1)

• Kumagai K, Kjellin A, Tsai JA, Thorell A, Granqvist S, Lundell L, Hakanson B. Toupet versus Dor as a procedure to prevent reflux after cardiomyotomy for achalasia: results of a randomised clinical trial. Int J Surg. 2014;12(7):673-80. doi: 10.1016/j.ijsu.2014.05.077. Epub 2014 Jun 2.

  PMID: 24892729 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Myotomy; Receptors, Opioid, delta

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Receptors, Opioid; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Neuropeptide; Receptors, Neurotransmitter; Receptors, Peptide

Study Officials

• Lars R Lundell, Professor

  Gastrocentrum Karolinska University Hospital, Stockholm Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: September 2, 2013
• Study Start: May 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 2, 2013

Record last verified: 2013-08

Locations

SE (1)