The effect of postsurgery execise on recovery from colorectal cancer surgery
| ISRCTN | ISRCTN56928944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56928944 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/02/2012
- Registration date
- 28/02/2012
- Last edited
- 27/06/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
134 Shinchon-Dong
Seodaemun-Gu
Yonsei University
Seoul
120-749
Korea, South
| Phone | +82 2 2123 6197 |
|---|---|
| jjeon@yonsei.ac.kr |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Postoperative exercise will reduce the time of hospital stay, time to flatus and time to the first normal diet |
| Ethics approval(s) | Institutional Ethics Review Board at Yonsei University College of Medicine, ref: 2004-2010-0147 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2011 |
| Completion date | 01/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 20 patients in each group |
| Key inclusion criteria | 1. Stage 1-3 colon cancer 2. Aged between 18-70 3. Able to read and understand Korean language |
| Key exclusion criteria | 1. Patient with recurrent cancer 2. Patient with body mass index (BMI) less than 18 kg/m2 or over BMI 30kg/m2 |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
120-749
Korea, South
Sponsor information
Hospital/treatment centre
c/o Nam Kyu Kim
Department of Surgery
250 Seongsan-ro
Seodaemun-gu
Seoul
120-752
Korea, South
"ROR" |
https://ror.org/01wjejq96 |
|---|
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
