NCT02455739

Brief Summary

The investigators aimed to assess whether postoperative gum chewing improve intestinal functions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

May 20, 2015

Last Update Submit

May 27, 2015

Conditions

Gastrointestinal Disorder Postoperative

Keywords

intestinal functionchewing gum

Outcome Measures

Primary Outcomes (1)

  • Gastrointesitinal function

    Gastrointesitinal function will be assess by bowel sound for every 2 hours and time of flatulence will be recorded

    postoperative first 48 hours

Study Arms (2)

chewing gum positive

EXPERIMENTAL

chewing gum group will chew gum

Other: chewing gum

chewing gum negative

NO INTERVENTION

chewing gum group will not chew gum

Interventions

chewing gumOTHER

postoperative gum chewing to improve gastrointestinal function

chewing gum positive

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women underwent gynecologic operation
  • Women who are eligible for gum chewing

You may not qualify if:

  • Women with previous gastrointestinal intervantion
  • Women with previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ateş Karateke, md

    Zeynep Kamil

    STUDY DIRECTOR

Central Study Contacts

enis ozkaya, md

CONTACT

905054742459enozkaya1979@gmail.com

Taylan şenol, md

CONTACT

905054037490taylan_senol@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 28, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

TU(1)