NCT03611413

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

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

March 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3.3 years

First QC Date

July 18, 2018

Last Update Submit

August 7, 2018

Conditions

Keywords

COLON PERFORATION SURGERY

Outcome Measures

Primary Outcomes (1)

  • number of items completed of ERAS protocol

    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

Study Arms (2)

ERAS programme

Patients who have been treated under an ERAS programm

Procedure: ERAS care

conventional care

Patients who have been treated under an conventional care

Interventions

ERAS carePROCEDURE

ERAS PROTOCOL

ERAS programme

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

emergency surgery with a diagnosis of left colon perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 2, 2018

Study Start

March 1, 2014

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

August 8, 2018

Record last verified: 2018-08