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Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02399631
Enrollment
180
Registered
2015-03-26
Start date
2012-01-31
Completion date
2016-12-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Perioperative treatment, Laparoscopic surgery

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.

Interventions

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

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay30 days post-operativelyDuration 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 stay30 days post-operatively

Secondary

MeasureTime frameDescription
30-day mortality30 days from time of surgery
Readmission rate30 days from time of surgery
Nutritional statusup to 30days from time of surgeryBody weight, body mass index, body composition, before and after surgery
Quality of lifeup to 30days from time of surgeryEORTC QLQ-C30, before and after surgery
30-day morbidity30 days from time of surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026