NCT00879294

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
Last Updated

November 6, 2017

Status Verified

July 1, 2017

First QC Date

April 9, 2009

Last Update Submit

November 2, 2017

Conditions

Perforated Appendicitis

Keywords

Perforated appendicitisRuptured appendicitisAcute appendicitis with perforation

Outcome Measures

Primary Outcomes (1)

  • Time to resolution of post-operative ileus.

    1-14 days

Study Arms (3)

1 Wristband

SHAM COMPARATOR

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

Device: Motion sickness wristband

Chewing Gum

EXPERIMENTAL

Patients will be randomized to use chewing gum after surgery.

Dietary Supplement: Chewing Gum

Control

NO INTERVENTION

Usual post-operative care.

Interventions

Motion sickness wristbandDEVICE

No drugs are involved.

1 Wristband
Chewing GumDIETARY_SUPPLEMENT

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

Chewing Gum

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • any child who has undergone appendectomy for perforated appendicitis

You may not qualify if:

  • age less than or equal to 5 years
  • unable to chew gum safely
  • interval appendectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brenner Children's Hospital

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Thomas Pranikoff, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Last Updated

November 6, 2017

Record last verified: 2017-07

Locations

US(1)