SurgeryNCT04170322
Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy
A study testing thin pvc gastric tube and thick silicone gastric tube in people with Surgery and Calibration Tube, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Calibration Tube
- What is being tested?
- thin pvc gastric tube and thick silicone gastric tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- revision procedure
- known eosophageal or gastric anatomical abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.
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
Read the 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.
- Conditions
- Surgery, Calibration Tube
- Being tested
- thin pvc gastric tube, thick silicone gastric tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thin pvc gastric tubeDevice
a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon
thick silicone gastric tubeDevice
a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon
| Study group | Role | What they receive |
|---|---|---|
| thin pvc gasrtric calibration tube | Experimental | 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. Receives: Device: thin pvc gastric tube |
| thick silicone gastric calibration tube | Active comparator | 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 Receives: Device: thick silicone gastric tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
introduction time
time from introduction until first staple in minutes
Measured: intraoperative
Secondary outcomes (1)
rate of changing tube
Impossible for correct positioning requiring change to another tube
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Mulier, AZ Sint-Jan AV
- Investigators
- Jan Paul Mulier, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170322
- Sponsor's protocol ID
- 2019RCTgastrictube
- Status last verified
- Mar 2020
- First submitted
- 18 Nov 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Introduction Time of Thin Pvc Versus Thick Silicone Gastric Calibration Tubes for Sleeve Gastrectomy.
- ClinicalTrials.gov ID
- NCT04170322
- Acronym / sponsor ID
- 2019RCTgastrictube
- Conditions
- Surgery, Calibration Tube
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| thin pvc gasrtric calibration tube | Experimental | Device: thin pvc gastric tubethin 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. |
| thick silicone gastric calibration tube | Active comparator | Device: thick silicone gastric tubethick 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- revision procedure
- known eosophageal or gastric anatomical abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thin pvc gastric tubea thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon | Device | thin pvc gasrtric calibration tube |
| thick silicone gastric tubea thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon | Device | thick silicone gastric calibration tube |
Primary outcome
introduction time
Time frame: intraoperative
time from introduction until first staple in minutes
1 secondary outcome
rate of changing tube
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Paul Mulier principal investigator
AZ Sint-Jan AV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thin pvc gastric tube and thick silicone gastric tube in people with Surgery and Calibration Tube, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Paul Mulier, MD PhhD (+3250452490, jan.mulier@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
introduction time (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.