NCT02219607

Brief Summary

The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery. Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

August 16, 2014

Last Update Submit

August 16, 2014

Conditions

Fluid Balance

Outcome Measures

Primary Outcomes (1)

  • Change in liver enzymes

    5 days postoperatively

Secondary Outcomes (1)

  • Change in BNP (brain natriuretic peptide)

    5 days

Study Arms (2)

epidural

general anesthesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing colorectal surgery

You may qualify if:

  • Patients undergoing colorectal surgery

You may not qualify if:

  • Severe cardiac failure Severe renal failure Severe liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon Hospital

Chaïdári, 12462, Greece

RECRUITING

Central Study Contacts

Ageliki Pandazi, MD,PhD

CONTACT

00302105832374angpant@med.uoa.gr

Study Design

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

Study Record Dates

First Submitted

August 16, 2014

First Posted

August 19, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

GR(1)