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

This study has been completed.
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01131416
First received: May 25, 2010
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative interval until the first passage of stool [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: No ]
  • Clinically significant postoperative ileus [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: No ]
  • Postoperative hospital stay [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: Yes ]
  • Related complications [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: Yes ]
  • Patients' satisfaction [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   15 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kittipat Charoenkwan, M.D., Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01131416     History of Changes
Other Study ID Numbers: 10FEB010938
Study First Received: May 25, 2010
Last Updated: June 27, 2011
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on May 23, 2013