Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery

July 13, 2011 updated by: ChaingMai University

Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial

Gum chewing can promotes the return bowel function after gynecologic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Amphoe Muang, Chiang Mai, Thailand, 50200
        • Faculty of Medicine, Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

  • Perioperative hyperalimentation
  • Recent chemotherapy (within 3 weeks before surgery)
  • Previous bowel surgery
  • Inflammatory bowel disease
  • Previous abdominal or pelvic radiation
  • Need for immediate postoperative endotracheal intubation
  • Need for postoperative admission to intensive care unit
  • Undergoing emergency surgery with oral intake of fluid or food with in 4 hours before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional
Conventional postoperative feeding schedule
Experimental: Gum Chewing
Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
Behavioral: Gum chewing
Gum chewing(30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in the addition to conventional postoperative feeding schedule
Other Names:
  • Sugar free and calcium free gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first flatus
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative complications
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery
Time to first regular diet
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery
Time to first defecation
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery
Incidence and severity of postoperative nausea, vomiting and abdominal discomfort
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery
Hospital stay
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery
Patients's satisfaction
Time Frame: Up to 7 days after surgery
Up to 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ChaingMai University

Collaborators

Chiang Mai University

Investigators

  • Principal Investigator: Manatsawee - Manopunya, MD, Chiang Mai University, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 13, 2011

First Posted (Estimate)

July 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10OCT010402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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