Impact of Chewing Gum on Postoperative Gut Motility in Gastrointestinal Surgery Patients

February 16, 2026 updated by: Khyber Medical University Peshawar

Impact of Chewing Gum on Postoperative Gut Motility in Gastrointestinal Surgery Patients: A Randomized Controlled Trial at Khyber Teaching Hospital, Peshawar, Pakistan

Postoperative ileus (POI) is a frequent complication after abdominal surgery, leading to delayed gastrointestinal motility, prolonged hospital stay, and increased patient discomfort. Chewing gum, as a form of sham feeding, has been proposed to stimulate gut motility through vagal stimulation and increased gastrointestinal secretions. This randomized controlled trial aims to assess the effect of chewing gum on early recovery of gastrointestinal motility in patients undergoing open gastrointestinal surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective randomized controlled trial will evaluate whether chewing gum reduces the time to return of bowel function after gastrointestinal surgery. Ninety-six adult patients undergoing open gastrointestinal surgery will be randomly allocated into intervention and control groups using block randomization. The intervention group will receive glucose-containing chewing gum starting six hours postoperatively. Outcomes measured include time to first bowel sounds, passage of flatus, and defecation. Statistical analysis will assess differences between groups to determine the efficacy of chewing gum in preventing postoperative ileus.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 17 and 85 years.
  • Patients of either gender.
  • Undergoing open gastrointestinal surgical procedures (elective or emergency).
  • Willing to participate and able to provide informed consent.

Exclusion Criteria:

  • Patients with metabolic or endocrine disorders (diabetes mellitus, hypothyroidism, or hyperthyroidism).
  • Patients with renal disease or electrolyte imbalance.
  • Patients with chronic constipation or neuromuscular disorders.
  • Patients with substance abuse or drug addiction.
  • Patients receiving medications affecting gut motility (calcium channel blockers or antiepileptic drugs).
  • Patients with dental prosthesis or undergoing laparoscopic gastrointestinal surgery.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chewing Gum Intervention Group
Participants will receive glucose/carbohydrate-containing chewing gum starting 6 hours after surgery. Patients will chew gum for 15 minutes, three times daily, for 48 hours or until first passage of flatus or stool, in addition to standard postoperative care.
Behavioral: Chewing Gum
Participants will chew glucose/carbohydrate-containing chewing gum for 15 minutes, three times daily, starting 6 hours after surgery and continuing for 48 hours or until the first passage of flatus or stool, in addition to standard postoperative care.
No Intervention: Standard Care Control Group
Participants will receive standard postoperative care without chewing gum intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to First Passage of Flatus
Time Frame: Within 48 hours postoperatively
Time interval (in hours) from the end of surgery to the first postoperative passage of flatus, assessed by patient self-report and clinical evaluation.
Within 48 hours postoperatively
Time to First Defecation
Time Frame: Within 48 hours postoperatively
Time interval (in hours) from the end of surgery to the first postoperative bowel movement (defecation), assessed by patient self-report and clinical evaluation.
Within 48 hours postoperatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Khyber Medical University Peshawar

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Khyber Teaching Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr Ali Raza, MBBS, Khyber Teaching Hospital
  • Principal Investigator: Dr Munir Ahmed, FCPS, Khyber Teaching 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.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMU/DIR/CTU/2025/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) related to study outcomes, baseline characteristics, and statistical analyses will be shared with qualified researchers upon reasonable request, after publication of the primary study results. Data will be shared to promote transparency and facilitate further research while ensuring participant confidentiality.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.

IPD Sharing Access Criteria

Access to de-identified IPD will be granted to researchers who provide a methodologically sound research proposal, with approval from the principal investigator and institutional ethical review board. A data use agreement will be required prior to data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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