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

August 3, 2022 updated by: Poitiers University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France, 86021
        • Hospital center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of dysphagia
Time Frame: 3 months
clinically evaluated by the surgeon
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 12, 2019

Primary Completion (ACTUAL)

June 12, 2021

Study Completion (ACTUAL)

June 12, 2021

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EREDYS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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