NCT02885415

Brief Summary

the troponin level and ECGs pre and post operative will be used to determined prevalence of myocardial injury among patients undergoing gastrointestinal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

August 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 8, 2016

Last Update Submit

September 22, 2017

Conditions

Myocardial Injury

Outcome Measures

Primary Outcomes (2)

  • Change in Troponin

    Cahnges in Troponin levels Pre-Op and Day 1, Day 2 and Day 3 post-OP

    Pre-Op and 3 days series post-op results

  • ECG changes

    Changes as per Protocol Criteria

    Pre-Op and 48 hours post-op

Interventions

Gastrointestinal surgeryPROCEDURE

Major resectional gastrointestinal surgery (define as resection of part of gastrointestinal tract during esophageal, Gastric or colorectal surgeries)

Eligibility Criteria

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

Patients older than 18 years undergoing major resectional gastrointestinal surgery in Galway University Hospitals (UCHG, Mayo university Hospital), The Midland Regional Hospital, Tullamore and Letterkenny University Hospital will be asked to join the study and will considered eligible after informed consent and information handouts provided.

You may qualify if:

  • Patients older than 18 years undergoing major resectional gastrointestinal surgery (define as resection of part of gastrointestinal tract ( oesophageal, Gastric or colorectal surgeries)

You may not qualify if:

  • \- Documented Pre-op Myocardium Injury
  • Refused or unable to give informed consent
  • Laparoscopic fundoplication
  • Laparoscopic cholecystectomy surgery
  • Appendectomy surgery
  • Hernia repair surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Collage Hospital Galway

Galway, Co Galway, Ireland

Location

Letterkenny University Hospital

Letterkenny, Donegal, Ireland

Location

Mayo University Hospital

Castlebar, Mayo, Ireland

Location

Midland Regional Hospital, Tullamore

Tullamore, Ireland

Location

MeSH Terms

Interventions

Digestive System Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 31, 2016

Study Start

August 1, 2016

Primary Completion

August 5, 2017

Study Completion

September 5, 2017

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(4)