Effect of Xylitol Gum Chewing on Postoperative Bowel Activity

August 28, 2024 updated by: Giresun University

Efficacy of Chewing Xylitol Gum on Restoring Postoperative Bowel Activity After Laparoscopic Cholecystectomy: A Three-Arm Randomised Controlled Trial

Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. First flatus, first bowel movement, first defecation, first mobilization time, and discharge time from hospital were recorded. Symptoms included nausea, and vomiting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Purpose: Laparoscopic cholecystectomy (LC) has become the standard treatment for gallbladder surgery due to its advantages over open surgery. However, postoperative ileus (POI) remains a common complication. Gum chewing has been proposed to stimulate bowel function post-surgery, but it's unclear whether xylitol in gum influences outcomes. Our objective was to evaluate the effects of postoperative xylitol gum chewing on gastrointestinal functional recovery after laparoscopy.

Design: A Three-Arm Randomized Controlled Trial Methods: Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. The first flatus, first bowel movement, first defecation, first mobilization time, and discharge time from the hospital were recorded. Symptoms included nausea and vomiting.

Study Type

Interventional

Enrollment (Actual)

75

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

  • Turkey
    • Piraziz
      • Giresun, Piraziz, Turkey, 28000
        • Esra Ozkan

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Turkish-speaking,
  • Verbal communication,
  • Cognitive abilities are normal,
  • No psychiatric diagnosis,
  • 40 to 65 years old,
  • He's having a laparoscopic cholecystectomy,
  • ASA (American Society of Anaesthesiologists) Score-I and II,
  • who has no problem chewing gum,
  • who's going to have scheduled surgery,
  • The prescribed duration of surgery not exceeding 100 minutes,
  • Patients whose oral intake was to be opened after 6 hours.

Exclusion Criteria:

  • Having emergency surgery,
  • Liver failure,
  • Kidney failure,
  • Muscle disease
  • Those with a known allergy to the anesthesia drugs used and morbidly obese,
  • The one with the walking problem,
  • The one with the jaw problem,
  • Patients who cannot be contacted,
  • With a post-operative nasogastric tube,
  • Patients whose oral intake would be opened less than 6 hours were excluded from the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chewing gum with xylitol
Chewing gum with xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
Other: xylitol chewing gum
Chewing gum with xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
Placebo Comparator: Chewing gum with non-xylitol
Chewing gum with non-xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
Other: xylitol chewing gum
Chewing gum with xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
No Intervention: Control group
to standardize the control group patients, all the procedures applied in the intervention group were applied, only the gum was not chewed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first postsurgical flatus, Time to first bowel sound after surgery, Time to first postsurgical defecation, First Mobilization time, Discharge time from hospital
Time Frame: Baseline
The onset of time to first postsurgical flatus, time to first bowel sound after surgery, Time to first postsurgical defecation, first mobilization time, discharge time from hospital were evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the feeding at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea After Surgery, Vomiting After Surgery
Time Frame: Baseline
Nausea and vomiting were evaluated and all information was recorded.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

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.

General Publications

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 (Actual)

May 5, 2023

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Xylitol12345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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