Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy
Primary Purpose
Postoperative Ileus
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sugar Free Chewing Gum
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Ileus
Eligibility Criteria
Inclusion Criteria:
- Patients of either gender with age ranging from 15 to 60 years.
- Patients whose ileostomies were made for typhoid or tuberculous perforation
- 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.
Sites / Locations
- Services hospital lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sugar Free Chewing Gum
Control
Arm Description
All patients receiving sugar free gum
Patients receiving no intervention
Outcomes
Primary Outcome Measures
passage of flatus
Secondary Outcome Measures
Full Information
NCT ID
NCT02155153
First Posted
June 1, 2014
Last Updated
January 29, 2016
Sponsor
Services Hospital, Lahore
1. Study Identification
Unique Protocol Identification Number
NCT02155153
Brief Title
Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy
Official Title
The Effect of Gum Chewing on the Duration of Postoperative Ileus and Total Length of Hospital Stay After Reversal of Ileostomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Services Hospital, Lahore
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar Free Chewing Gum
Arm Type
Experimental
Arm Description
All patients receiving sugar free gum
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receiving no intervention
Intervention Type
Other
Intervention Name(s)
Sugar Free Chewing Gum
Other Intervention Name(s)
'Extra' Sugar Free Gum
Intervention Description
'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.
Primary Outcome Measure Information:
Title
passage of flatus
Time Frame
within 48 hours after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either gender with age ranging from 15 to 60 years.
Patients whose ileostomies were made for typhoid or tuberculous perforation
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmood Ayyaz, FCPS FACS
Organizational Affiliation
Professor of Surgery
Official's Role
Study Director
Facility Information:
Facility Name
Services hospital lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
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Role of Chewing Gum in Reducing Post Operative Ileus After Reversal of Ileostomy
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