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NCT03374930 Clinical Trial

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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03374930
Other study ID # EREDYS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2019
Est. completion date June 12, 2021

Study information
Verified date August 2022
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date June 12, 2021
Est. primary completion date June 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Multiple rapid swallows test
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.

Locations
Country Name City State
France Hospital Center Poitiers

Sponsors (1)
Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary presence of dysphagia clinically evaluated by the surgeon 3 months
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