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Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

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ClinicalTrials.gov Identifier: NCT02399631
Recruitment Status : Terminated
First Posted : March 26, 2015
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University

Brief Summary:
An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.

Condition or disease Intervention/treatment Phase
Colon Cancer Other: Enhanced recovery program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
Study Start Date : January 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: ERAS group
early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery
Other: Enhanced recovery program
Enhanced recovery program day-1: no mechanical bowel preparation, intake permit until 6 hrs before operation day0: operation, postoperative fluid therapy, antibiotics day1: liquid diet, early ambulation, removal of foley catheterization day2-3: soft diet day 4-5: discharge

No Intervention: Congrol group
Traditional, conventional perioperative treatment



Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 30 days post-operatively ]

    Duration of hospital stay from the date of operation to the date when a patient meets the following "discharge criteria".

    Discharge criteria:

    • Tolerance of consecutive 3 soft diet
    • Recovery of bowel function (without PONV)
    • No necessity of intravenous analgesics
    • Stable vital sign (afebrile)

  2. Actual hospital stay [ Time Frame: 30 days post-operatively ]

Secondary Outcome Measures :
  1. Readmission rate [ Time Frame: 30 days from time of surgery ]
  2. 30-day morbidity [ Time Frame: 30 days from time of surgery ]
  3. 30-day mortality [ Time Frame: 30 days from time of surgery ]
  4. Quality of life [ Time Frame: up to 30days from time of surgery ]
    EORTC QLQ-C30, before and after surgery

  5. Nutritional status [ Time Frame: up to 30days from time of surgery ]
    Body weight, body mass index, body composition, before and after surgery



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligibility rule of enrollment
  • ECOG 0-2
  • Pathologically diagnosed colon cancer
  • Stage I-III
  • No functional disturbance in liver, kidney, bone marrow
  • Informed consent

Exclusion Criteria:

  • Emergent operation
  • Obstructive or perforated cancer
  • Rectosigmoid or rectal cancer
  • Synchronous tumor
  • Uncontrolled psychiatric or neurologic problems
  • Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  • Renal dysfunction (Cr ≥2mg/dl)
  • Recent MI, CVA, nitrate medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399631


Locations
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Korea, Republic of
Gyu seog Choi
Daegu, Korea, Republic of, 702-210
Sponsors and Collaborators
Kyungpook National University
Investigators
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Study Chair: Gyu-Seog Choi, MD Kyunpook National Univercity Medical Center

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Responsible Party: Gyu-Seog Choi, Director, Head of colorectal cancer center, Principal Investigator, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02399631     History of Changes
Other Study ID Numbers: KNUHCRC005
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Gyu-Seog Choi, Kyungpook National University:
Perioperative treatment
Laparoscopic surgery

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases