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

NCT ID: NCT02155153

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sugar Free Chewing Gum

All patients receiving sugar free gum

Group Type: EXPERIMENTAL

Sugar Free Chewing Gum

Intervention Type: 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.

Control

Patients receiving no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

'Extra' Sugar Free Gum

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Services Hospital, Lahore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. SamiUllah

Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmood Ayyaz, FCPS FACS

Role: STUDY_DIRECTOR

Professor of Surgery

Locations

Services hospital lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

cg1

Identifier Type: -

Identifier Source: org_study_id