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

NCT ID: NCT03374930

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2021-06-12

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Multiple rapid swallows test

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Center

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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EREDYS

Identifier Type: -

Identifier Source: org_study_id

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