The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
GUM01
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 28, 2011
June 1, 2011
1.1 years
May 25, 2010
June 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative interval until the first flatus
Up to 7 days after delivery
Secondary Outcomes (5)
Postoperative interval until the first passage of stool
Up to 7 days after delivery
Clinically significant postoperative ileus
Up to 7 days after delivery
Postoperative hospital stay
Up to 7 days after delivery
Related complications
Up to 7 days after delivery
Patients' satisfaction
Up to 7 days after delivery
Study Arms (2)
Gum chewing
EXPERIMENTALGum 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
Conventional
NO INTERVENTIONConventional postoperative feeding schedule
Interventions
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
Eligibility Criteria
You may qualify if:
- Pregnant women undergoing cesarean delivery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kittipat Charoenkwan, MD
Faculty of Medicine, Chiang Mai University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 27, 2010
Study Start
May 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06