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The Effect of Gum Chewing on Postoperative Ileus

NCT ID: NCT00879294

Last Updated: 2017-11-06

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if chewing gum after surgery for perforated appendicitis will shorten the time of intestinal dysfunction.

Detailed Description

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After operations for a ruptured appendix, children are usually not allowed to eat or drink anything. This is because the infection inside the abdomen and the manipulation of the intestines during the operation cause the bowels to stop their normal movement. The resulting lack of bowel function is called an "ileus". When this occurs, intestinal secretions and anything taken in by mouth can become backed up, causing bloating, abdominal pain, nausea and vomiting. Children are not allowed to eat or drink anything during this time and require fluid hydration through an IV or even nutrition through an IV. This ileus usually lasts an average of 4-5 days, and can sometimes delay the discharge of children who are otherwise ready to go. The purpose of this research study is to determine if simple things, like gum chewing or anti-motion sickness bracelets can help speed the time it takes for the bowels to begin working after an operation for a ruptured appendix. Because the gum is not swallowed, it does not have the same effects as eating and drinking would on someone with an ileus. The same is true for the anti-motion sickness bracelets. Yet, it is thought that the chewing action from gum may stimulate the intestines into thinking that food is on the way and cause them to start working sooner than they otherwise might. The same may be true for the bracelets, and some studies show them to be helpful with nausea after surgery. Nevertheless, the effects of a bracelet on postoperative ileus are unproven.

Conditions

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Perforated Appendicitis

Keywords

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Perforated appendicitis Ruptured appendicitis Acute appendicitis with perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1 Wristband

Some patients will be randomized to wear a motion sickness wristband which does not have any drug effect.

Group Type SHAM_COMPARATOR

Motion sickness wristband

Intervention Type DEVICE

No drugs are involved.

Chewing Gum

Patients will be randomized to use chewing gum after surgery.

Group Type EXPERIMENTAL

Chewing Gum

Intervention Type DIETARY_SUPPLEMENT

Patients will be asked to chew gum for 20 minutes, four times daily.

Control

Usual post-operative care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motion sickness wristband

No drugs are involved.

Intervention Type DEVICE

Chewing Gum

Patients will be asked to chew gum for 20 minutes, four times daily.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* any child who has undergone appendectomy for perforated appendicitis

Exclusion Criteria

* age less than or equal to 5 years
* unable to chew gum safely
* interval appendectomy
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Pranikoff, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Brenner Children's Hospital

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CR1_IRB00005677

Identifier Type: -

Identifier Source: org_study_id