DysphagiaNCT03374930
Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
A study testing Multiple rapid swallows test in people with Dysphagia, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Multiple rapid swallows test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2019to 12 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dysphagia
- Being tested
- Multiple rapid swallows test
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple rapid swallows testProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple rapid swallows test | Other | 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. Receives: Procedure: Multiple rapid swallows test |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of dysphagia
clinically evaluated by the surgeon
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start12 Dec 2019
- Primary completion12 Jun 2021
- Study completion12 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374930
- Sponsor's protocol ID
- EREDYS
- Status last verified
- Aug 2022
- First submitted
- 12 Dec 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery
- ClinicalTrials.gov ID
- NCT03374930
- Acronym / sponsor ID
- EREDYS
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 12 Jun 2021 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple rapid swallows test | Other | Procedure: Multiple rapid swallows testMultiple 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple rapid swallows testMultiple 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 or surgery | Multiple rapid swallows test |
Primary outcome
presence of dysphagia
Time frame: 3 months
clinically evaluated by the surgeon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple rapid swallows test in people with Dysphagia, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of dysphagia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.