Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

January 23, 2018 updated by: Gyu-Seog Choi, Kyungpook National University Hospital

Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days post-operatively
Actual hospital stay
Time Frame: 30 days post-operatively
30 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission rate
Time Frame: 30 days from time of surgery
30 days from time of surgery
30-day morbidity
Time Frame: 30 days from time of surgery
30 days from time of surgery
30-day mortality
Time Frame: 30 days from time of surgery
30 days from time of surgery
Quality of life
Time Frame: up to 30days from time of surgery
EORTC QLQ-C30, before and after surgery
up to 30days from time of surgery
Nutritional status
Time Frame: up to 30days from time of surgery
Body weight, body mass index, body composition, before and after surgery
up to 30days from time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Study Chair: Gyu-Seog Choi, MD, Kyunpook National Univercity Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 21, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUHCRC005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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