Back to resultsInfluence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Primary Purpose
Dysphagia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiple rapid swallows test
Sponsored by
About this trial
This is an interventional diagnostic trial for Dysphagia
Eligibility Criteria
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
Sites / Locations
- Hospital Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multiple rapid swallows test
Arm Description
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.
Outcomes
Primary Outcome Measures
presence of dysphagia
clinically evaluated by the surgeon
Secondary Outcome Measures
Full Information
NCT ID
NCT03374930
First Posted
December 12, 2017
Last Updated
August 3, 2022
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03374930
Brief Title
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Official Title
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
June 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple rapid swallows test
Arm Type
Other
Arm Description
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
Intervention Name(s)
Multiple rapid swallows test
Intervention Description
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 Outcome Measure Information:
Title
presence of dysphagia
Description
clinically evaluated by the surgeon
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Center
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
We'll reach out to this number within 24 hrs