Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.

August 7, 2018 updated by: Antonio Arroyo Sebastian
A study was designed with a prospective cohort of all patients undergoing urgent surgery for left colon perforation between March 2014 and June 2017 who were treated according to a specific ERAS programme (ERAS group/29 patients). This group was compared with a historic case-matched control group with conventional care (CC group/21 patients). The main endpoints were postoperative 30-day morbidity, length of postoperative hospital stay, rate of readmission within 30 days, and mortality. The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS) between 6-11 points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

emergency surgery with a diagnosis of left colon perforation

Description

Inclusion Criteria:

  • The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS), between 6-11 points.

Exclusion Criteria:

  • The exclusion criteria were patients under 18 years old and patients with a high risk of mortality according to a PSS equal to or greater than 12 points.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ERAS programme
Patients who have been treated under an ERAS programm
Procedure: ERAS care
ERAS PROTOCOL
conventional care
Patients who have been treated under an conventional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of items completed of ERAS protocol
Time Frame: 1-month
to analyze the applicability of a specific ERAS protocol in the management of patients with left colon perforation requiring emergency colon surgery, it will be analyzed the number of items completed of ERAS protocol (YES/NO)
1-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonio Arroyo Sebastian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERM-01-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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