Back to resultsEffects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
Primary Purpose
Paralytic Ileus
Status
Withdrawn
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Gum chewing
Sponsored by
About this trial
This is an interventional supportive care trial for Paralytic Ileus
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital
Exclusion Criteria:
- Perioperative hyperalimentation
- Recent chemotherapy (within 3 weeks before surgery)
- Previous bowel surgery
- Inflammatory bowel diseases
- Previous abdominal or pelvic radiation
- Need for immediate postoperative endotracheal intubation
- Need for postoperative admission to intensive care unit
- Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery
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
Time to first flatus
Secondary Outcome Measures
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort
Incidence of postoperative complications
Time to first regular diet
Time to first defecation
Postoperative analgesics requirement
Hospital stay
Patients' satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01389986
Brief Title
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
Official Title
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol 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
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
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
Time to first flatus
Time Frame
Up to 7 days after surgery
Secondary Outcome Measure Information:
Title
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort
Time Frame
Up to 7 days after surgery
Title
Incidence of postoperative complications
Time Frame
Up to 7 days after surgery
Title
Time to first regular diet
Time Frame
Up to 7 days after surgery
Title
Time to first defecation
Time Frame
Up to 7 days after surgery
Title
Postoperative analgesics requirement
Time Frame
Up to 7 days after surgery
Title
Hospital stay
Time Frame
On the day of hospital discharge, an expected average of 7 days
Title
Patients' satisfaction
Time Frame
Up to 7 days after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital
Exclusion Criteria:
Perioperative hyperalimentation
Recent chemotherapy (within 3 weeks before surgery)
Previous bowel surgery
Inflammatory bowel diseases
Previous abdominal or pelvic radiation
Need for immediate postoperative endotracheal intubation
Need for postoperative admission to intensive care unit
Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipat Charoenkwan, MD
Organizational Affiliation
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
Learn more about this trial
Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
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