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

NCT02155153 | Completed

• 1 other identifier: cg1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (1)

• passage of flatus

  within 48 hours after the operation

Study Arms (2)

Sugar Free Chewing Gum

EXPERIMENTAL

All patients receiving sugar free gum

Other: Sugar Free Chewing Gum

Control

NO INTERVENTION

Patients receiving no intervention

Interventions

Sugar Free Chewing Gum OTHER

'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.

Also known as: 'Extra' Sugar Free Gum

Sugar Free Chewing Gum

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.
• \. Patients whose ileostomy was made for any condition other than typhoid or tuberculosis.

Sponsors & Collaborators

• Services Hospital, Lahore: lead

Study Sites (1)

Services hospital lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

• Mahmood Ayyaz, FCPS FACS

  Professor of Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 1, 2016

Record last verified: 2016-01

Locations

PA (1)