Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Not Applicable

Terminated

• Conditions: Colon Cancer
• Interventions: Other: Enhanced recovery program

• Registration Number: NCT02399631
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-21
• Study First Posted: 2015-03-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS group	Enhanced recovery program	early recovery program with no preoperative mechanical bowel preparation, early diet initiation, and prevention of postoperative ileus after elective laparoscopic colon cancer surgery

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	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)
Actual hospital stay	30 days post-operatively

Secondary Outcome Measures

Name	Time	Method
Quality of life	up to 30days from time of surgery	EORTC QLQ-C30, before and after surgery
Nutritional status	up to 30days from time of surgery	Body weight, body mass index, body composition, before and after surgery
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

Trial Locations

Locations (1)

Gyu seog Choi; 🇰🇷 Daegu, Korea, Republic of