Observational Study Comparing Gastric Calibration Tubes

NCT ID: NCT04170400

Last Updated: 2019-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-12-31

Brief Summary

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Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

Detailed Description

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Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery.

Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done.

some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

Conditions

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Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

Exclusion Criteria

* pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Jan Mulier

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Paul Mulier

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

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Azsintjan

Bruges, , Belgium

Site Status

Countries

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Belgium

Central Contacts

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Jan Paul Mulier

Role: CONTACT

+3250452490

jan Mulier

Role: CONTACT

Other Identifiers

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2019OSgastrictube

Identifier Type: -

Identifier Source: org_study_id

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