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

Status

Completed

Conditions

Intervention / Treatment

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

      • 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.
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
Time to first bowel movement,
Time Frame: from postoperative day 0 till an expected average of day 7
The first bowel motion also occurred earlier in the intervention group (22 vs 52 hours, p<0.001)
from postoperative day 0 till an expected average of day 7
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

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

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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