NCT01613274

Brief Summary

The purpose of this study is to determine if chewing mint-flavored sugarless gum after colon resection surgery decrease the time to first flatus, bowel movement and length of stay in the hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 22, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

June 3, 2012

Last Update Submit

April 21, 2014

Conditions

Colon Resection

Keywords

colon resection

Outcome Measures

Primary Outcomes (1)

  • Time to first flatus

    Every 4 hours following surgery until discharge, which is an average of 5 days

Secondary Outcomes (2)

  • Time to first bowel movement

    Every 4 hours following surgery until discharge, which is an average of 5 days

  • Length of stay in days

    Patients will be followed until discharge, which is an average of 5 days

Study Arms (2)

Gum chewing

EXPERIMENTAL

Chewing mint flavored sugarless gum for 10-20 minutes three times a day following colon resection.

Other: gum chewing

no gum chewing

PLACEBO COMPARATOR

no gum chewing

Other: no gum chewing

Interventions

gum chewingOTHER

gum chewing three times a day for up to 20 minutes

Gum chewing
no gum chewingOTHER

no gum chewing

no gum chewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to Unit 2600
  • Age 18-100 years of age
  • Alert and oriented
  • Post-operative open or laparoscopic colon resection
  • English speaking.

You may not qualify if:

  • Confused, or with cognitive disabilities that render the patient unable to answer questions about bowel motility.
  • Admitted to any other unit except 2600
  • Use of an epidural catheter for pain control post-operatively
  • Documented history of irritable bowel syndrome
  • Colostomy (new or old)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Julie A Sabo, RN Mn CNS-BC

    United Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2012

First Posted

June 7, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

April 22, 2014

Record last verified: 2014-04

Locations

US(1)