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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

May 25, 2010
June 27, 2011
May 2010
June 2011   (final data collection date for primary outcome measure)
Postoperative interval until the first flatus [ Time Frame: Up to 7 days after delivery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131416 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Paralytic Ileus
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
  • 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
    Intervention: Behavioral: Gum chewing
  • No Intervention: Conventional
    Conventional postoperative feeding schedule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
15 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01131416
10FEB010938
No
Kittipat Charoenkwan, M.D., Faculty of Medicine, Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Kittipat Charoenkwan, MD Faculty of Medicine, Chiang Mai University
Chiang Mai University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP