Effectiveness of Gum Chewing on Ileus in Chinese Colorectal Patients Underwent Laparoscopic Colorectal Surgery
1 other identifier
interventional
92
1 country
1
Brief Summary
Gum chewing group will have less ileus and early resume of bowel motion than control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 21, 2018
June 1, 2018
11 months
March 4, 2015
June 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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).
from postoperative day 0 till an expected average of day 7
Secondary Outcomes (3)
Time to first sense of hunger
from postoperative day 0 till an expected average of day 7
Time to first bowel movement,
from postoperative day 0 till an expected average of day 7
Length of stay
from postoperative day 0 till an expected average of day 7
Study Arms (2)
bubble gum chewing and routine care
EXPERIMENTALStart chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged
routine care
NO INTERVENTIONNon interventional group will receive existing routine care as usual
Interventions
Chewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shum Nga Fanlead
Study Sites (1)
Queen Mary Hospital
Hong Kong, China
Related Publications (1)
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.
PMID: 27654648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nga Fan Shum
Hospital Authority, Queen Mary Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- APN
Study Record Dates
First Submitted
March 4, 2015
First Posted
April 17, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2015
Study Completion
June 1, 2016
Last Updated
June 21, 2018
Record last verified: 2018-06