Plain English Summary
Background and study aims
A transient postoperative ileus, a temporary disturbance in gastric and bowel motility following surgery, is recognized as an expected outcome of any major abdominal surgery including colon and rectum. Delayed recovery from the surgery would also delay the initiation of subsequent therapies. Therefore, it is important to find modality which may reduce postoperative ileus and enhance recovery from the surgery as early as possible. In recent years, the Enhance Recovery after Surgery (ERAS) aimed at improving before and after surgery care and decreasing postoperative complication, has been used extensively. Techniques include optimal pain control by epidural (anaesthetic drug injected in spine) and local anaesthesia, minimally invasive techniques and aggressive post-operative rehabilitation, which include early feeding, removal of tube, early ambulation (walking). Although studies examined the safety, efficacy and effectiveness of this protocol on surgery outcomes including the length of hospital study, these studies did not measure the effects of early ambulation separately. Therefore, the purposes of the current study are 1) to investigate the effects of post-surgery exercise on surgery outcomes including the length of hospital stay, time to flatus (passing wind) and time to first normal diet, 2) to investigate the association between surgery outcomes change in body measurements and fitness levels during recovery from surgery.
Who can participate?
Patients who are admitted to Severance hospital for stage 1-3 colon cancer can participate in the study. To take part you need to be aged 18 years or older, have a good understanding of Korean language and is willing to participate in the study.
What does the study involve?
Patients will be randomly allocated to control group (usual care) or exercise group. In the exercise group patients will undergo 1-15 minute exercise under the guidance of exercise therapist. Fitness will be measured before the surgery and one day before the hospital release.
What are the possible benefits and risks of participating?
Participants randomized to the exercise group will receive personalized exercise program while they are staying at the hospital after the surgery.
All exercise is symptom limited and therefore if the patient feels pain or do not want to exercise, then he/she does not have to exercise. There are no known risks to participants.
Where is the study run from?
The study takes place at Severance Hospital located at Shinchon, Seoul, Korea
When is the study starting and how long is it expected to run for?
Patients were enrolled in the study between May 2011 to Feb 2012
Who is funding the study?
Ministry of Health and Welfare in Korean Goverment
Who is the main contact?
Dr Nam Kyu Kim
namkyuk@yuhs.ac
Trial website
Contact information
Type
Scientific
Primary contact
Prof Justin Jeon
ORCID ID
Contact details
134 Shinchon-Dong
Seodaemun-Gu
Yonsei University
Seoul
120-749
Korea
South
+82 2 2123 6197
jjeon@yonsei.ac.kr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Postoperative exercise reduced the length of hospital stay among stage 1 to 3 colon cancer patients: Randomized controlled trial of efficacy and safety of exercise protocol
Acronym
Study hypothesis
Postoperative exercise will reduce the time of hospital stay, time to flatus and time to the first normal diet
Ethics approval
Institutional Ethics Review Board at Yonsei University College of Medicine, ref: 2004-2010-0147
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stage I to III colon cancer
Intervention
Randomized into either an exercise or usual care group via minimization method.
Exercise group - The patient will undergo 1-15 minute exercise under the guidance of exercise therapist.
The other group will undergo usual care during their recovery from surgery.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The length of hospital stay
2. Time to flatus
3. Time to the first normal diet
Secondary outcome measures
1. Fitness
2. Body composition
Measured before the surgery and one day before the hospital release
Overall trial start date
01/03/2011
Overall trial end date
01/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Stage 1-3 colon cancer
2. Aged between 18-70
3. Able to read and understand Korean language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 patients in each group
Participant exclusion criteria
1. Patient with recurrent cancer
2. Patient with body mass index (BMI) less than 18 kg/m2 or over BMI 30kg/m2
Recruitment start date
01/03/2011
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Korea, South
Trial participating centre
134 Shinchon-Dong
Seoul
120-749
Korea, South
Funders
Funder type
Government
Funder name
National Research Foundation of Korea (NRF) (Korea, South) (No.2011-0004892)
Alternative name(s)
NRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Korea, South
Funder name
National R & D program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (1120230)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary