NCT00831246

Brief Summary

This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

January 27, 2009

Last Update Submit

August 18, 2018

Conditions

Ileus

Keywords

Ileus,Gynecologic surgery,Post-operative,Flatus

Outcome Measures

Primary Outcomes (1)

  • Incidence of ileus

    Until ileus formation or first flatus post-op

Study Arms (2)

1

EXPERIMENTAL

Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.

Other: chewing gum - Extra Winterfresh

2

SHAM COMPARATOR

Patients are given standard post-op care with clear liquid diet as tolerated .

Other: Standard Post-Op Care

Interventions

chewing gum - Extra WinterfreshOTHER

Patients are given standard post-op care with clear liquid diet as tolerated plus chewing gum q8 for 30minute chewing intervals.

1
Standard Post-Op CareOTHER

Patients are given standard post-op care with clear liquid diet as tolerated.

2

Eligibility Criteria

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

You may qualify if:

  • All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.

You may not qualify if:

  • Patient deemed legally incompetent to sign their own consent
  • Women under the age of 18
  • Patients lacking their own or a false set of teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

MeSH Terms

Conditions

IleusFlatulence

Condition Hierarchy (Ancestors)

Intestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Hopkins, MD

    Aultman Health Foundation

    STUDY CHAIR

  • James M Clark, MD

    Aultman Health Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

US(1)