The Effects of Gum Chewing on Bowel Function Recovery Fol... | NCT01131416

Studies
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section

NCT01131416

Sponsor

Chiang Mai University

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

Paralytic Ileus

Interventions

Gum chewing

Countries

Thailand

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 25, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 27, 2010Estimated

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

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.

Detailed Description

Not provided

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

Phase 2Phase 3

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
Gum chewing	Experimental	Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule	Behavioral: Gum chewing
Conventional	No Intervention	Conventional postoperative feeding schedule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gum chewing	Behavioral	Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative interval until the first flatus		Up to 7 days after delivery

Secondary Outcomes

Measure	Description	Time Frame
Postoperative interval until the first passage of stool		Up to 7 days after delivery
Clinically significant postoperative ileus		Up to 7 days after delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women undergoing cesarean delivery

Exclusion Criteria:

Perioperative hyperalimentation
Recent chemotherapy
Concurrent bowel surgery
Previous bowel surgery
Concurrent bowel obstruction
History of inflammatory bowel diseases
Previous abdominal/pelvic radiation
Postoperative placement of endotracheal tube/nasogastric tube
Postoperative admission to intensive care unit

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kittipat Charoenkwan, MD	Faculty of Medicine, Chiang Mai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Chiang Mai University		Chiang Mai	Chiang Mai	50200	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007418	Intestinal Pseudo-Obstruction

Ancestor Terms

ID	Term
D045823	Ileus
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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