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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03928678
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
19.1
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: enhanced recovery after surgery program in colorectal cancer surgery
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: thefast track (FTS group)

Procedure: enhanced recovery after surgery program in colorectal cancer surgery
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.
Placebo Comparator: Thecontrolgroup

Procedure: enhanced recovery after surgery program in colorectal cancer surgery
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.

Outcome Measures

Primary Outcome Measures

  1. length of hospital stay in days [4 days]

    length of hospital stay in days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 South Egypt Cancer Instuite Assuit Egypt 171516

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Adel El sherif,MD, lecturer of anesthesia, Assiut University
ClinicalTrials.gov Identifier:
NCT03928678
Other Study ID Numbers:
  • 458
First Posted:
Apr 26, 2019
Last Update Posted:
Mar 22, 2022
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colonic Neoplasms

Study Results

No Results Posted as of Mar 22, 2022