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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03374930

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dysphagia	Procedure: Multiple rapid swallows test	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 12, 2019

Actual Primary Completion Date :

Jun 12, 2021

Actual Study Completion Date :

Jun 12, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

presence of dysphagia [3 months]
clinically evaluated by the surgeon

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Center	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT03374930

Other Study ID Numbers:

EREDYS

First Posted:

Dec 15, 2017

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Deglutition Disorders

Study Results

No Results Posted as of Aug 4, 2022