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出境医 / 临床实验 / Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

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

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
Cancer of Colon Procedure: enhanced recovery after surgery program in colorectal cancer surgery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 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 [ Time Frame: 4 days ]
    length of hospital stay in days


Eligibility Criteria
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Ages Eligible for Study:   18 Years 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

Locations
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Egypt
South Egypt Cancer Instuite
Assuit, Egypt, 171516
Sponsors and Collaborators
Assiut University
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		length of hospital stay in days [ Time Frame: 4 days ]
length of hospital stay in days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial
Official Title  ICMJE Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Cancer of Colon
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: thefast track (FTS group)
    Intervention: Procedure: enhanced recovery after surgery program in colorectal cancer surgery
  • Placebo Comparator: Thecontrolgroup
    Intervention: Procedure: enhanced recovery after surgery program in colorectal cancer surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 24, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928678
Other Study ID Numbers  ICMJE 458
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fatma Adel El sherif,MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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