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Observational Study Comparing Gastric Calibration Tubes

Observational Study Comparing Thin Pvc With Thick Silicone Gastric Calibration Tube for Bariatric Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04170400
Enrollment
100
Registered
2019-11-20
Start date
2019-12-31
Completion date
2020-12-31
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Brief summary

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

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 ...

Interventions

None listed

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
need to change gastric tubeintraoperativerate of changing gastric tube
introduction timeintraoperativetime from start insertion till first staple in minutes

Countries

Belgium

Contacts

Primary ContactJan Paul Mulier
jan.mulier@azsintjan.be+3250452490
Backup Contactjan Mulier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026