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

Countess of Chester NHS Foundation Trust

Status: Unknown

Conditions: Surgery; Colorectal Cancer

Treatments: Dietary Supplement: Chewing gum

Study type: Interventional

Funder types: Other

Identifiers

NCT02372500

Surg050/14

Details and patient eligibility

About

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.

Full 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)

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Emergency colorectal surgery, unable to consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Chewing gum

Experimental group

Description:

Patients will chew sugar free gum three times a day

Treatment:

Dietary Supplement: Chewing gum

Control

No Intervention group

Description:

Normal post operative care