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

Sponsor
Services Hospital, Lahore (Other)
Overall Status
Completed
CT.gov ID
NCT02155153
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
18
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sugar Free Chewing Gum
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Gum Chewing on the Duration of Postoperative Ileus and Total Length of Hospital Stay After Reversal of Ileostomy
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. passage of flatus [within 48 hours after the operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    1. Patients whose ileostomy was made for any condition other than typhoid or tuberculosis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Services hospital lahore Lahore Punjab Pakistan 54000

    Sponsors and Collaborators

    • Services Hospital, Lahore

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. SamiUllah, Medical Officer, Services Hospital, Lahore
    ClinicalTrials.gov Identifier:
    NCT02155153
    Other Study ID Numbers:
    • cg1
    First Posted:
    Jun 4, 2014
    Last Update Posted:
    Feb 1, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Ileus

    Study Results

    No Results Posted as of Feb 1, 2016