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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01884 | Registry Identifier | NCI CTRP | |
| 10445215 | Other Grant/Funding Number | NINR |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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After having abdominal surgery, patients often experience a lack of bowel function that can cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as "post-operative ileus." Patients are usually not allowed to leave the hospital until their doctor is sure that their bowel function has returned.
The goal of this clinical research study is to compare using a rocking chair to the standard of care in improving post-operative ileus after abdominal surgery.
The standard method used to help the return of bowel function after surgery is to have patient get out of bed, sit in a chair for a period of time, and then begin walking the first day after surgery. Patients are then asked to increase the time they spend sitting in the chair and walking every day. However, it is not clear that this is the best method to assist in the return of normal bowel function. Some studies have shown that rocking in a rocking chair may help normal bowel function to return more quickly.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:
No matter what group you are in, you will also be asked to begin walking the first day after surgery until you pass gas for the first time after surgery.
You will wear an activity recorder all day attached to a wrist band in order to record your time spent in bed, in the rocking or non-rocking chair, and an activity monitor around your waist to record the time and distance walked during each 24-hour period. The study staff will show you how to wear this activity recorder. You will be encouraged by the study staff to increase the time spent in the chair and walking each day.
You will be given a pencil and pad of paper to note the date and time you first pass gas after surgery.
Study Tests:
On the day before you have surgery, the following tests and procedures will be performed:
Every morning while you are in the hospital and until you pass gas for the first time after surgery:
Length of Study:
You will be on study from the first day after surgery until you pass gas (usually about 3-5 days). You will be taken off study if you cannot tolerate rocking in a rocking chair, sitting in a non-rocking chair, or walking, due to discomfort or any other reason.
This is an investigational study. There are no additional costs to you for taking part in this study.
Up to 80 patients will take part in the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | Experimental | Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day. |
|
| Rocking Motion Group | Experimental | Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Procedure | Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Rocking Chair Motion on Surgical-Induced Stress | Efficacy of rocking chair motion on surgical-induced stress response as measured by salivary cortisol sample collected each morning in two groups of colon cancer patients recovering from abdominal surgery randomized to receive either a rocking chair motion intervention or standard care. | 3 - 5 days |
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Inclusion Criteria:
Exclusion Criteria:
1) All others will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Xin S. Wang, MD, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Rocking Chair Motion | Procedure | Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day. |
|
| Questionnaire | Behavioral | Beginning on day of surgery till discharge (3-5 days) |
|
|
| D005767 |
| Gastrointestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |