Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Conditions
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Colon Cancer

Intervention / Treatment
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* Other: Enhanced recovery program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>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<br>* 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<br>|
| No Intervention: Congrol group<br>Traditional, conventional perioperative treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | EORTC QLQ-C30, before and after surgery | up to 30days from time of surgery | 
| Nutritional status | Body weight, body mass index, body composition, before and after surgery | up to 30days from time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative treatment, Laparoscopic surgery