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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
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paralytic Ileus

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

First Posted
May 25, 2010
Last Updated
June 27, 2011
Sponsor
Chiang Mai University
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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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