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Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Primary Purpose

Colon Cancer

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Enhanced recovery program
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Perioperative treatment, Laparoscopic surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gyu seog Choi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ERAS group

Congrol group

Arm Description

early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery

Traditional, conventional perioperative treatment

Outcomes

Primary Outcome Measures

Length of hospital stay
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)
Actual hospital stay

Secondary Outcome Measures

Readmission rate
30-day morbidity
30-day mortality
Quality of life
EORTC QLQ-C30, before and after surgery
Nutritional status
Body weight, body mass index, body composition, before and after surgery

Full Information

First Posted
March 9, 2015
Last Updated
January 23, 2018
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02399631
Brief Title
Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
Official Title
Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Perioperative treatment, Laparoscopic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery
Arm Title
Congrol group
Arm Type
No Intervention
Arm Description
Traditional, conventional perioperative treatment
Intervention Type
Other
Intervention Name(s)
Enhanced recovery program
Intervention Description
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
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
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)
Time Frame
30 days post-operatively
Title
Actual hospital stay
Time Frame
30 days post-operatively
Secondary Outcome Measure Information:
Title
Readmission rate
Time Frame
30 days from time of surgery
Title
30-day morbidity
Time Frame
30 days from time of surgery
Title
30-day mortality
Time Frame
30 days from time of surgery
Title
Quality of life
Description
EORTC QLQ-C30, before and after surgery
Time Frame
up to 30days from time of surgery
Title
Nutritional status
Description
Body weight, body mass index, body composition, before and after surgery
Time Frame
up to 30days from time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyu-Seog Choi, MD
Organizational Affiliation
Kyunpook National Univercity Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Gyu seog Choi
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of

12. IPD Sharing Statement

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Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

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