Chewing Gum on Postoperative Ileus in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Traditional postoperative care has been challenged recently to improve and speedup recovery (including the return of bowel function) such that patients can be discharged to home more quickly. This approach includes earlier mobilization of the patient, and introducing solid food sooner. Additionally, there is evidence in adults to suggest that "sham feeding" by chewing gum may also speed up bowel recovery so the patient may tolerate a solid diet earlier.

The aim of this study is to determine if gum chewing can enhance bowel recovery in children who undergo abdominal surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RCT Gum Chewing on Bowel Function After Abdominal Surgery in Children

NCT02261454

Postoperative Ileus

WITHDRAWN NA

Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients

NCT01583452

Post Operative Ileus

COMPLETED PHASE1

Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus

NCT05296967

Postoperative Ileus

COMPLETED NA

Gum Chewing Reduces the Risk of Postoperative Ileus After Arthroplasty Procedures in The Elderly Population

NCT04489875

Paralytic Ileus

UNKNOWN NA

The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section

NCT01131416

Paralytic Ileus

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After intestinal surgery, many patients suffer from a "postoperative ileus" (POI). The cause is multifactorial and can be attributed to surgery itself, the lingering effect of the anesthetic, the use of narcotics and decreased mobility of the patient.

An ileus can delay the time to full diet, thus lengthening the hospital stay of the patient - sometimes up to several weeks.

There is evidence that early drinking/eating and increased mobility may accelerate the return of bowel function. "Fast-tracking" is well documented in the adult literature; protocols have been put in place to enhance GI tract recovery and thus decrease the morbidity of a prolonged hospital stay and ileus. "Fast-tracking" has been done in pediatric patients but not in a large RCT for abdominal surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bowel Ileus Flatus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a prospective randomized, controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No gum chewing

Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Gum chewing

Usual pharmacologic treatment and post-operative care (e.g. daily visits by surgical team, antibiotics where appropriate, mobilization, advancement of diet as tolerated). Analgesia and anti-emetics will be provided (both oral and intravenous) as needed.

Intervention: 1 piece of sugarless gum to be chewed three times daily for 1 hour each.

Group Type EXPERIMENTAL

Gum chewing

Intervention Type OTHER

1 piece of sugarless gum to be chewed three times daily for 1 hour each.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gum chewing

1 piece of sugarless gum to be chewed three times daily for 1 hour each.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children more than or equal to 4 years of age
* Children who undergo abdominal surgery (both laparoscopic or open)
* Children who have an expected postoperative length of stay more than 24 hours

Exclusion Criteria

* Children who are less than 4 years of age
* Children who are unable to chew gum/swallow (e.g. intubated, decreased level of consciousness, cognitive or physical disability)
* Children or their parents are not willing to sign consent
* Children or their parents are unable to follow directions regarding gum chewing,
* Children who have a GI dysmotility disorder (e.g. chronic intestinal pseudo-obstruction)

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes