Gum Chewing and Postoperative Intestinal Function After G... | NCT02455739

Studies
Gum Chewing and Postoperative Intestinal Function After Gynecolgic Operations

NCT02455739

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status

Unknown status

Last Update Posted

May 28, 2015Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Gastrointestinal Disorder Postoperative

Interventions

chewing gum

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

May 27, 2015

First Posted Date

May 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

enis ozkaya, medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training HospitalPrincipal Investigator

Lead Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

We will randomize patients into two groups after gynecologic operations. One group will chew gum, the other group not and we will assess the gastrointestinal function functions.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
chewing gum	Other	postoperative gum chewing to improve gastrointestinal function	chewing gum positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women underwent gynecologic operation
Women who are eligible for gum chewing

Exclusion Criteria:

Women with previous gastrointestinal intervantion
Women with previous abdominal surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
enis ozkaya, md	Contact	905054742459		enozkaya1979@gmail.com
Taylan şenol, md	Contact	905054037490		taylan_senol@hotmail.com

Overall Officials

Name	Affiliation	Role
Ateş Karateke, md	Zeynep Kamil	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zeynep Kamil	Recruiting	Istanbul			Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D002638	Chewing Gum

Ancestor Terms

ID	Term
D053149	Plant Gums
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

Not provided

Browse Branches

Not provided