Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

NCT ID: NCT02399631

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Enhanced recovery program

Intervention Type: OTHER

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

Congrol group

Traditional, conventional perioperative treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gyu-Seog Choi

Director, Head of colorectal cancer center, Principal Investigator, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gyu-Seog Choi, MD

Role: STUDY_CHAIR

Kyunpook National Univercity Medical Center

Locations

Gyu seog Choi

Daegu, , South Korea

Countries

South Korea

Other Identifiers

KNUHCRC005

Identifier Type: -

Identifier Source: org_study_id