NCT02419586

Brief Summary

Gum chewing group will have less ileus and early resume of bowel motion than control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

March 4, 2015

Last Update Submit

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

EXPERIMENTAL

Start chewing gum on postoperative day at three times daily with no more than 30 minutes till discharged

Other: bubble gum

routine care

NO INTERVENTION

Non 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.

bubble gum chewing and routine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

Location

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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Nga Fan Shum

    Hospital Authority, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

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

Locations