Condition category
Cancer
Date applied
17/02/2012
Date assigned
28/02/2012
Last edited
27/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Yonsei University College of Medicine (Korea, South)

Sponsor details

c/o Nam Kyu Kim
Department of Surgery
250 Seongsan-ro
Seodaemun-gu
Seoul
120-752
Korea
South

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes