NCT03374930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

December 12, 2017

Last Update Submit

August 3, 2022

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

  • presence of dysphagia

    clinically evaluated by the surgeon

    3 months

Study Arms (1)

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.

Procedure: Multiple rapid swallows test

Interventions

Multiple rapid swallows testPROCEDURE

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.

Multiple rapid swallows test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Center

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 15, 2017

Study Start

December 12, 2019

Primary Completion

June 12, 2021

Study Completion

June 12, 2021

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)