The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section (GUM01)

June 27, 2011 updated by: Chiang Mai University

The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial

Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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, 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

13 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women undergoing cesarean delivery

Exclusion Criteria:

  • Perioperative hyperalimentation
  • Recent chemotherapy
  • Concurrent bowel surgery
  • Previous bowel surgery
  • Concurrent bowel obstruction
  • History of inflammatory bowel diseases
  • Previous abdominal/pelvic radiation
  • Postoperative placement of endotracheal tube/nasogastric tube
  • Postoperative admission to intensive care unit

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 addition to conventional postoperative feeding schedule
No Intervention: Conventional
Conventional postoperative feeding schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative interval until the first flatus
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative interval until the first passage of stool
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery
Clinically significant postoperative ileus
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery
Postoperative hospital stay
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery
Related complications
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery
Patients' satisfaction
Time Frame: Up to 7 days after delivery
Up to 7 days after delivery

Collaborators and Investigators

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

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Kittipat Charoenkwan, MD, Faculty of Medicine, Chiang Mai University

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

May 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10FEB010938

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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