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

NCT ID: NCT02372500

Last Updated: 2015-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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)

Conditions

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Colorectal Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Chewing gum

Patients will chew sugar free gum three times a day

Group Type EXPERIMENTAL

Chewing gum

Intervention Type DIETARY_SUPPLEMENT

Sugar free chewing gum

Control

Normal post operative care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chewing gum

Sugar free chewing gum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Emergency colorectal surgery, unable to consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Countess of Chester NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dale Vimalachandran

Consultant Colorectal Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dale Vimalachandran, MD FRCS

Role: STUDY_DIRECTOR

Countess of Chester

Rachel Clifford, MRCS

Role: PRINCIPAL_INVESTIGATOR

Countess of Chester

Locations

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Countess of Chester Hospital

Chester, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Dale Vimalachandran, MD FRCS

Role: CONTACT

4401244365475

Sheila Williams

Role: CONTACT

Other Identifiers

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Surg050/14

Identifier Type: -

Identifier Source: org_study_id

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