NCT04172545

Brief Summary

Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

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
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

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 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 19, 2019

Last Update Submit

March 20, 2020

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • thickness of staple line

    thickness of staple line measured in micrometers

    intra operative on excised stomach before being discarded

Interventions

staplingPROCEDURE

staples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling.

Eligibility Criteria

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

obese patients undergoing bariatric surgery for the first time and where a sleeve gastrectomy is performed.

You may qualify if:

  • primary sleeve gastrectomy

You may not qualify if:

  • stomach disease
  • prior surgery on the stomach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

  • Jan Paul Mulier

    AZSint Jan AV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Paul Mulier, MD PhD

CONTACT

+3250452490jan.mulier@azsintjan.be

Mulier

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)