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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155153
• Other study ID #: cg1
• Status: Completed
• Phase: N/A
• First received: June 1, 2014
• Last updated: January 29, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ileus
• Postoperative Ileus

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Services hospital lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	passage of flatus		within 48 hours after the operation	No