NCT06342687

Brief Summary

The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
468

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post operative 5 year survival rate

    5 years

Study Arms (2)

Group 1

with a compliance rate with ERAS below 80%

Group 2

with a compliance rate with ERAS of 80% or above

Procedure: High compliance with ERAS protocol

Interventions

Patients were categorized into two groups based on their adherence to the ERAS protocol: group 1 with a compliance rate below 80% and group 2 with a compliance rate of 80% or above.

Group 2

Eligibility Criteria

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

The patients will be divided into two groups based on ERAS protocol compliance. Group 1 comprised patients with adherence below 80%, while Group 2 consisted of individuals who maintained adherence levels of no less than 80%. We established this threshold based on the compliance target set in our clinic.

You may qualify if:

  • patients undergoing treatment for colorectal cancer

You may not qualify if:

  • primary open or emergency surgery,
  • transanal endoscopic microsurgery (TEM),
  • stage IV of the disease according to the American Joint Committee on Cancer (AJCC) classification,
  • multivisceral resection,
  • concomitant inflammatory bowel diseases,
  • intensive care unit stay immediately after surgery
  • lost-to-follow-up patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Medical College

Krakow, Lesser Poland Voivodeship, 31-008, Poland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations