Trial of Chewing Gum to Reduce Post Operative Ileus in El... | NCT02372500

Studies
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

NCT02372500

Sponsor

Countess of Chester NHS Foundation Trust

Status

Unknown status

Last Update Posted

Feb 26, 2015Estimated

Enrollment

130Estimated

Phase

Not Applicable

Conditions

Colorectal Cancer
Surgery

Interventions

Chewing gum

Countries

United Kingdom

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 20, 2015

First Posted Date

Feb 26, 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

Feb 20, 2015

Last Update Posted Date

Feb 26, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dale Vimalachandran, Consultant Colorectal Surgeon, Countess of Chester NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Countess of Chester NHS Foundation TrustOTHER

Collaborators

Not provided

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

It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.

Detailed Description

Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

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

130Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chewing gum	Experimental	Patients will chew sugar free gum three times a day	Dietary Supplement: Chewing gum
Control	No Intervention	Normal post operative care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chewing gum	Dietary Supplement	Sugar free chewing gum	Chewing gum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bowel function (as assessed by questionnaire)	Time to passage of flatus	Minutes (end of surgery to first passage of flatus, measured up to 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Diet (as assessed by questionnaire)	Time to tolerating full diet	Minutes (end of surgery to first solid food, assessed by patient questionnaire up to 4 weeks from randomisation)
Length of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing elective colorectal surgery (open and laparoscopic), able to given informed consent

Exclusion Criteria:

Emergency colorectal surgery, unable to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dale Vimalachandran, MD FRCS	Contact	4401244365475		dale.vimalachandran@nhs.net
Sheila Williams	Contact			sheila.williams4@nhs.net

Overall Officials

Name	Affiliation	Role
Dale Vimalachandran, MD FRCS	Countess of Chester	Study Director
Rachel Clifford, MRCS	Countess of Chester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Countess of Chester Hospital		Chester	Cheshire	CH2 1UL	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

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