NCT04648644

Brief Summary

This study defines a standardized protocol inspired to the ERAS philosophy for the peri-operative treatment of patients undergoing emergency abdominal surgery. Primary endpoint is the feasibility of the application of the standardized protocol; secondary endpoint is the safety

Trial Health

87
On Track

Trial Health Score

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

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

8 active sites

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

November 3, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

November 23, 2020

Last Update Submit

July 27, 2022

Conditions

Enhanced Recovery After SurgeryEmergency Surgery

Outcome Measures

Primary Outcomes (1)

  • Feasibility: % of application of post-operative ERAS items

    Compliance to the standardize protocol for each item

    30 days

Secondary Outcomes (1)

  • Safety: complications rate within 30 days

    30 days

Study Arms (1)

Study population

All patients undergoing emergency abdominal surgery for infection or occlusion and treated with bowel resection with or without anastomosis; intestinal bypass or adhesiolysis

Other: Application of ERAS protocol

Interventions

Application of ERAS protocolOTHER

Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery

Study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing emergency surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

You may qualify if:

  • patients undergoing emergency abdominal surgery for abdominal sepsis or occlusion and treated with bowel resection with or without anastomosis, intestinal bypass or adhesiolysis.

You may not qualify if:

  • age \<18
  • emergency surgery for post-operative complications of post diagnostic procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ospedale Manzoni

Lecco, LC, Italy

Location

ASST Monza

Monza, MB, 20900, Italy

Location

Ospedale San Raffaele

Milan, Mi, Italy

Location

ASST Lodi

Lodi, Italy

Location

Azienda ospedaliero-universitaria Pisana,Ospedale Cisanello

Pisa, Italy

Location

Ospedale San Jacopo

Pistoia, Italy

Location

Policlinico Gemelli

Roma, Italy

Location

Ospedale di Cattinara

Trieste, Italy

Location

Study Officials

  • Marco Braga, MD

    University of Milano Bicocca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

November 3, 2020

Primary Completion

March 30, 2022

Study Completion

June 30, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(8)