Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
March 19, 2022 updated by: Fatma Adel El sherif,MD, Assiut University
Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Assuit, Egypt, 171516
- South Egypt Cancer Instuite
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≤ 60 years,
- Good nutrition,
- No systemic infection and
- Elective laparoscopic surgery
Exclusion Criteria:
- Age >75 years,
- Malnutrition or an organ system infection
- Associated with obstruction, bleeding, emergency surgery or other surgical intervention
- Tumor with extensive metastasis
- Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support
- Previous history of abdominal surgery
- Patient have previously undergone gastrostomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: thefast track (FTS group)
|
to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.
|
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Placebo Comparator: Thecontrolgroup
|
to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
length of hospital stay in days
Time Frame: 4 days
|
length of hospital stay in days
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2019
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
April 24, 2019
First Submitted That Met QC Criteria
April 24, 2019
First Posted (Actual)
April 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 19, 2022
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 458
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.