Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Colon Cancer Clinical Trial

Official title:

Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02399631
• Other study ID #: KNUHCRC005
• Status: Terminated
• Phase: N/A
• First received: March 9, 2015
• Last updated: January 23, 2018
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Gyu seog Choi	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Actual hospital stay		30 days post-operatively
Secondary	Readmission rate		30 days from time of surgery
Secondary	30-day morbidity		30 days from time of surgery
Secondary	30-day mortality		30 days from time of surgery
Secondary	Quality of life	EORTC QLQ-C30, before and after surgery	up to 30days from time of surgery
Secondary	Nutritional status	Body weight, body mass index, body composition, before and after surgery	up to 30days from time of surgery