Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

AZ Sint-Jan AV

Status: Unknown

Conditions: Calibration Tube; Surgery

Treatments: Device: thick silicone gastric tube; Device: thin pvc gastric tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04170322

2019RCTgastrictube

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: only primary sleeve gastrectomy

Exclusion Criteria:

• revision procedure
• known eosophageal or gastric anatomical abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

thin pvc gasrtric calibration tube

Experimental group

Description:

thin pvc gastric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy.

Treatment:

Device: thin pvc gastric tube

thick silicone gastric calibration tube

Active Comparator group

Description:

thick silicone gastrric calibration tube is inserted after intubation to release gas from the stomach, then moved in correct position to help surgeon construct a sleeve gastrectomy

Treatment:

Device: thick silicone gastric tube