- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419586
Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
June 19, 2018 updated by: Shum Nga Fan
Effectiveness of Gum Chewing on Reduction of Postoperative Paralytic Ileus for Chinese Colorectal Cancer Patients Underwent Laparoscopic Colorectal Surgery and Enhanced Recovery Program
Gum chewing group will have less ileus and early resume of bowel motion than control group.
Study Overview
Detailed Description
The standardize surgical techniques, less used of epidural analgesia, early ambulation and used of naso-gastric tube for decompression are aimed to reduce the paralytic ileus after abdominal surgery .
Most Western studies have examined and found that gum chewing are able to prevent postoperative ileus or promotes early bowel function after abdominal surgery.
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, China
- Queen Mary Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with newly diagnosed colorectal cancer undergoing laparoscopic resection in in Queen Mary Hospital
- At least 18 years
- Speak Cantonese
- Able to follow study protocol and chewing gum study
Exclusion Criteria:
- Cognitive disability
- Requirement of epidural analgesia
- Requirement of intensive care unit/ High dependency unit care postoperatively
- Inability to chew
- Presence of procedure other than colorectal resection
- Non Chinese
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: bubble gum chewing and routine care
Start chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged
|
Chewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged.
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NO_INTERVENTION: routine care
Non interventional group will receive existing routine care as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first flatus
Time Frame: from postoperative day 0 till an expected average of day 7
|
Time to passage of flatus after surgery was significantly shorter in the intervention group (22 vs 39 hours, p=0.007).
|
from postoperative day 0 till an expected average of day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first sense of hunger
Time Frame: from postoperative day 0 till an expected average of day 7
|
Patients in the intervention group also noticed feeling of hunger earlier (17 vs 40 hours, p<0.001).
|
from postoperative day 0 till an expected average of day 7
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Time to first bowel movement,
Time Frame: from postoperative day 0 till an expected average of day 7
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The first bowel motion also occurred earlier in the intervention group (22 vs 52 hours, p<0.001)
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from postoperative day 0 till an expected average of day 7
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Length of stay
Time Frame: from postoperative day 0 till an expected average of day 7
|
There is no difference in length of stay between intervention group or control group
|
from postoperative day 0 till an expected average of day 7
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nga Fan Shum, Hospital Authority, Queen Mary Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
March 4, 2015
First Submitted That Met QC Criteria
April 14, 2015
First Posted (ESTIMATE)
April 17, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 21, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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