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Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04170322
Enrollment
100
Registered
2019-11-20
Start date
2020-08-31
Completion date
2021-12-31
Last updated
2020-03-23

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

Conditions

Calibration Tube, Surgery

Brief summary

Time from 40 Fr gastric calibration tube introduction on surgical request till first stapling is measured as introduction time. Problems to advance are noted A note is made If change to other type of gastric tube is needed

Detailed description

when ready to perform sleeve gastrectomy anesthesiologist is asked to introduce 40 Fr gastric calibration tube. A clock is running till first staple is fired as a measure of time to introduce. If problems to position 40 Fr gastric calibration tube correctly, if resistance to advance, change to other type of gastric tube and check again difficulties. Make a note of problems and reason to change.

Interventions

DEVICEthin pvc gastric tube

a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon

DEVICEthick silicone gastric tube

a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

randomized controlled trial

Eligibility

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

Inclusion criteria

only primary sleeve gastrectomy \-

Exclusion criteria

* revision procedure * known eosophageal or gastric anatomical abnormalities

Design outcomes

Primary

MeasureTime frameDescription
introduction timeintraoperativetime from introduction until first staple in minutes

Secondary

MeasureTime frameDescription
rate of changing tubeintraoperativeImpossible for correct positioning requiring change to another tube

Countries

Belgium

Contacts

Primary ContactJan Paul Mulier, MD PhhD
jan.mulier@azsintjan.be+3250452490
Backup Contactjan Mulier
jan.mulier@azsintjan.be003250452490

Outcome results

None listed

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