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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03928678

Recruitment Status Active, not recruiting

First Posted April 26, 2019

Last update posted July 9, 2020

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:Cancer of Colon
  • Intervention/Treatment: Procedure: enhanced recovery after surgery program in colorectal cancer surgery
  • Phase: N/A
Detailed Description

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 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. length of hospital stay in days [ Time Frame: 4 days ]
    length of hospital stay in days
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

Egypt
South Egypt Cancer Instuite
Assuit

Sponsors and Collaborators

Assiut University

More Information
  • Responsible Party: Assiut University
  • ClinicalTrials.gov Identifier: NCT03928678 History of Changes
  • Other Study ID Numbers: 458
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: July 9, 2020
  • Last Verified: April 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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