Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy

January 29, 2016 updated by: Dr. SamiUllah, Services Hospital, Lahore

The Effect of Gum Chewing on the Duration of Postoperative Ileus and Total Length of Hospital Stay After Reversal of Ileostomy

Postoperative ileus is generally referred to as the transient impairment of bowel motility after abdominal or other surgery and diagnosed by postoperative abdominal pain vomiting constipation and distension.

The potential complications of prolonged POI include increased postoperative pain, increased nausea and vomiting, pulmonary complications, poor wound healing, delay in resuming oral intake, delay in postoperative mobilization, prolonged hospitalization, and increased health-care costs. The estimated economic impact of POI in the United States is $7.5 billion per year, excluding the expenses of work loss.

In view of these complications and economic burden a number of pharmacologic and non-pharmacologic strategies have been adopted by the doctors all over the world to reduce the burden of postoperative ileus.These programs involve transverse or curved surgical incisions, removal of nasogastric tubes at the end of anesthesia, intraoperative and postoperative analgesia, early postoperative feeding, mobilization, and gum chewing.

The use of gum chewing has emerged as a new and simple modality for decreasing POI. And reviews have concluded that there is consistent benefit for patients from gum chewing after the intestinal surgery; colonic surgery and gynecological surgery.

This study is based on the hypothesis that postoperative gum chewing is beneficial in prevention of postoperative ileus after reversal of ileostomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Hospital Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of either gender with age ranging from 15 to 60 years.
  2. Patients whose ileostomies were made for typhoid or tuberculous perforation
  3. Patients with no distal obstruction on loopogram.

Exclusion Criteria:

- 1. Patients with age less than 15 years and greater than 60. 2. Patients having co-morbid factors such as diabetes and ischemic heart disease.

3. Patients whose ileostomy was made for any condition other than typhoid or tuberculosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugar Free Chewing Gum
All patients receiving sugar free gum
Other: Sugar Free Chewing Gum
'Extra' sugar free gum will be used as an intervention. Patients will be required to chew a gum for 30 min at intervals of 6 hours for first 48 hours post operatively or until they pass flatus.
Other Names:
  • 'Extra' Sugar Free Gum
No Intervention: Control
Patients receiving no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
passage of flatus
Time Frame: within 48 hours after the operation
within 48 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Hospital, Lahore

Investigators

  • Study Director: Mahmood Ayyaz, FCPS FACS, Professor of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 1, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cg1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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