Comparing Pvc or Silicone Gastric Calibration Tube During Sleeve Gastrectomy

NCT ID: NCT04170322

Last Updated: 2020-03-23

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Calibration Tube

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

thin pvc gasrtric calibration tube

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.

Group Type EXPERIMENTAL

thin pvc gastric tube

Intervention Type DEVICE

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

thick silicone gastric calibration tube

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

Group Type ACTIVE_COMPARATOR

thick silicone gastric tube

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

thin pvc gastric tube

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

Intervention Type DEVICE

thick silicone gastric tube

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

* revision procedure
* known eosophageal or gastric anatomical abnormalities
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jan Mulier

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Paul Mulier

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azsintjan

Bruges, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jan Paul Mulier, MD PhhD

Role: CONTACT

+3250452490

jan Mulier

Role: CONTACT

003250452490

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019RCTgastrictube

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.