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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01131416
First Posted: May 27, 2010
Last Update Posted: June 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chiang Mai University
  Purpose

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.


Condition Intervention Phase
Paralytic Ileus Behavioral: Gum chewing Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Postoperative interval until the first flatus [ Time Frame: Up to 7 days after delivery ]

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

Estimated Enrollment: 100
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131416


Locations
Thailand
Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Kittipat Charoenkwan, MD Faculty of Medicine, Chiang Mai University
  More Information

Responsible Party: Kittipat Charoenkwan, M.D., Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01131416     History of Changes
Other Study ID Numbers: 10FEB010938
First Submitted: May 25, 2010
First Posted: May 27, 2010
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases