The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section (GUM01)
Primary Purpose
Paralytic Ileus
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Gum chewing
Sponsored by
About this trial
This is an interventional treatment trial for Paralytic Ileus
Eligibility 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
Sites / Locations
- Faculty of Medicine, Chiang Mai University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gum chewing
Conventional
Arm Description
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
Conventional postoperative feeding schedule
Outcomes
Primary Outcome Measures
Postoperative interval until the first flatus
Secondary Outcome Measures
Postoperative interval until the first passage of stool
Clinically significant postoperative ileus
Postoperative hospital stay
Related complications
Patients' satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01131416
Brief Title
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
Acronym
GUM01
Official Title
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralytic Ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gum chewing
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional
Arm Type
No Intervention
Arm Description
Conventional postoperative feeding schedule
Intervention Type
Behavioral
Intervention Name(s)
Gum chewing
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative interval until the first flatus
Time Frame
Up to 7 days after delivery
Secondary Outcome Measure Information:
Title
Postoperative interval until the first passage of stool
Time Frame
Up to 7 days after delivery
Title
Clinically significant postoperative ileus
Time Frame
Up to 7 days after delivery
Title
Postoperative hospital stay
Time Frame
Up to 7 days after delivery
Title
Related complications
Time Frame
Up to 7 days after delivery
Title
Patients' satisfaction
Time Frame
Up to 7 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipat Charoenkwan, MD
Organizational Affiliation
Faculty of Medicine, Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
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The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
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