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Completed

NCT Number: NCT03374930

Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery

The main objective of this study is to evaluate, in a prospective cohort, the link between preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM) and the occurrence of post operative dysphagia after anti-reflux surgery.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Center

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with an indication validated at a fundoplication directed by a visceral surgeon from Vienne county
  • Patient sent for the realization of a preoperative HRM,
  • Patient giving consent to participate in the study.

Exclusion criteria

  • Patient unable to sign a consent or protected (minors, pregnant women, patient under guardianship),
  • History of oesophageal surgery or radiotherapy,
  • History of systemic pathology with oesophageal involvement,
  • Contraindication to an oesophageal manometry : altered general status and vigilance , important swallowing disorders

Treatment and study plan

Multiple rapid swallows test

Procedure

Multiple rapid swallows test consists in giving to patient 4 to 6 sips of 2 mL of water, with an interval less than 4 seconds between the different sips.

Primary outcomes

  1. presence of dysphagia

    Time frame: 3 months

    clinically evaluated by the surgeon

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 15, 2017
Registry last updated
Aug 4, 2022

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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