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

Colon Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611413
• Other study ID #: GERM-01-18
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Perforation
• Emergencies

Intervention

Procedure:
• ERAS care
ERAS PROTOCOL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Antonio Arroyo Sebastian

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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