Feasibility and Effects of an Enhanced Recovery vs Conven... | NCT03611413

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

NCT03611413

Sponsor

Antonio Arroyo Sebastian

Status

Completed

Last Update Posted

Aug 8, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Colon Perforation

Interventions

ERAS care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2014Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Jul 18, 2018

First Submission Date that Met QC Criteria

Aug 1, 2018

First Posted Date

Aug 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antonio Arroyo Sebastian, DOCTOR, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaSponsor-Investigator

Lead Sponsor

Antonio Arroyo SebastianOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ERAS care	Procedure	ERAS PROTOCOL	ERAS programme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

emergency surgery with a diagnosis of left colon perforation

Sampling Method

Probability Sample