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Completed

NCT Number: NCT01933373

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toupet

Procedure

Laparoscopic posterior partial fundoplication plus myotomy.

Other names: Laparascopic posterior partial fundoplication plus myotomy.

Dor

Procedure

Anterior partial fundoplication plus myotomy.

Other names: Anterior partial fundoplication plus myotomy.

Primary outcomes

  1. Dysphagia symptoms according to Eckhardt

    Time frame: up to five years follow up

Secondary outcomes

  1. Ambulatory esophageal PH

    Time frame: One and five years follow up

  2. Health-related quality of life according to Velanovich

    Time frame: One and five years follow up

  3. Timed barium esophagogram at 1, 2 and 5 minutes

    Time frame: One and five years follow up

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Ersta Hospital, Sweden

Registry information

Official study title

A Prospective Randomized Trial Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia. Comparing Toupet Versus DOR.

Important dates

Study start
2007
Primary completion
2011
Study completion
2012
First posted
Sep 2, 2013
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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