NCT02399631

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

March 9, 2015

Last Update Submit

January 23, 2018

Conditions

Colon Cancer

Keywords

Perioperative treatmentLaparoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • 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)

    30 days post-operatively

  • Actual hospital stay

    30 days post-operatively

Secondary Outcomes (5)

  • Readmission rate

    30 days from time of surgery

  • 30-day morbidity

    30 days from time of surgery

  • 30-day mortality

    30 days from time of surgery

  • Quality of life

    up to 30days from time of surgery

  • Nutritional status

    up to 30days from time of surgery

Study Arms (2)

ERAS group

EXPERIMENTAL

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

Congrol group

NO INTERVENTION

Traditional, conventional perioperative treatment

Interventions

Enhanced recovery programOTHER

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

ERAS group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyu seog Choi

Daegu, 702-210, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Gyu-Seog Choi, MD

    Kyunpook National Univercity Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of colorectal cancer center, Principal Investigator, Professor

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 26, 2015

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

KR(1)