Back to resultsEffectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
bubble gum
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
bubble gum chewing and routine care
routine care
Arm Description
Start chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged
Non interventional group will receive existing routine care as usual
Outcomes
Primary Outcome Measures
Time to first flatus
Time to passage of flatus after surgery was significantly shorter in the intervention group (22 vs 39 hours, p=0.007).
Secondary Outcome Measures
Time to first sense of hunger
Patients in the intervention group also noticed feeling of hunger earlier (17 vs 40 hours, p<0.001).
Time to first bowel movement,
The first bowel motion also occurred earlier in the intervention group (22 vs 52 hours, p<0.001)
Length of stay
There is no difference in length of stay between intervention group or control group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02419586
Brief Title
Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
Official Title
Effectiveness of Gum Chewing on Reduction of Postoperative Paralytic Ileus for Chinese Colorectal Cancer Patients Underwent Laparoscopic Colorectal Surgery and Enhanced Recovery Program
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shum Nga Fan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gum chewing group will have less ileus and early resume of bowel motion than control group.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bubble gum chewing and routine care
Arm Type
Experimental
Arm Description
Start chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged
Arm Title
routine care
Arm Type
No Intervention
Arm Description
Non interventional group will receive existing routine care as usual
Intervention Type
Other
Intervention Name(s)
bubble gum
Intervention Description
Chewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged.
Primary Outcome Measure Information:
Title
Time to first flatus
Description
Time to passage of flatus after surgery was significantly shorter in the intervention group (22 vs 39 hours, p=0.007).
Time Frame
from postoperative day 0 till an expected average of day 7
Secondary Outcome Measure Information:
Title
Time to first sense of hunger
Description
Patients in the intervention group also noticed feeling of hunger earlier (17 vs 40 hours, p<0.001).
Time Frame
from postoperative day 0 till an expected average of day 7
Title
Time to first bowel movement,
Description
The first bowel motion also occurred earlier in the intervention group (22 vs 52 hours, p<0.001)
Time Frame
from postoperative day 0 till an expected average of day 7
Title
Length of stay
Description
There is no difference in length of stay between intervention group or control group
Time Frame
from postoperative day 0 till an expected average of day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nga Fan Shum
Organizational Affiliation
Hospital Authority, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27654648
Citation
Shum NF, Choi HK, Mak JC, Foo DC, Li WC, Law WL. Randomized clinical trial of chewing gum after laparoscopic colorectal resection. Br J Surg. 2016 Oct;103(11):1447-52. doi: 10.1002/bjs.10277.
Results Reference
derived
Learn more about this trial
Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
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