NCT04170400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

November 18, 2019

Last Update Submit

November 19, 2019

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

  • need to change gastric tube

    rate of changing gastric tube

    intraoperative

  • introduction time

    time from start insertion till first staple in minutes

    intraoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient sheduled for bariatric surgery \> 18 year sold and most of the time morbid obese. BMI \> 35

You may qualify if:

  • bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure.

You may not qualify if:

  • pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

  • Jan Paul Mulier

    AZ Sint-Jan AV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Paul Mulier

CONTACT

+3250452490jan.mulier@azsintjan.be

jan Mulier

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

BE(1)