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Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

Primary Purpose

Cancer of Colon

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
enhanced recovery after surgery program in colorectal cancer surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cancer of Colon

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Egypt Cancer Instuite

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

thefast track (FTS group)

Thecontrolgroup

Arm Description

Outcomes

Primary Outcome Measures

length of hospital stay in days
length of hospital stay in days

Secondary Outcome Measures

Full Information

First Posted
April 24, 2019
Last Updated
March 19, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03928678
Brief Title
Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
Official Title
Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thefast track (FTS group)
Arm Type
Active Comparator
Arm Title
Thecontrolgroup
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
enhanced recovery after surgery program in colorectal cancer surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
length of hospital stay in days
Description
length of hospital stay in days
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
South Egypt Cancer Instuite
City
Assuit
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

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