Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by ChaingMai University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
ChaingMai University
Collaborator:
Chiang Mai University
Information provided by:
ChaingMai University
ClinicalTrials.gov Identifier:
NCT01394094
First received: July 13, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
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Purpose
Gum chewing can promotes the return bowel function after gynecologic surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Recovery of Bowel Function, Due to Gum Chewing |
Behavioral: Gum chewing |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by ChaingMai University:
Primary Outcome Measures:
- Time to first flatus [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence and severity of postoperative nausea, vomiting and abdominal discomfort [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: Yes ]
- Incidence of postoperative complications [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: Yes ]
- Time to first regular diet [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
- Time to first defecation [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
- Hospital stay [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
- Patients's satisfaction [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 the addition to conventional postoperative feeding schedule
Other Name: Sugar free and calcium free gum
|
|
No Intervention: Conventional
Conventional postoperative feeding schedule
|
Detailed Description:
Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital
Exclusion Criteria:
- Perioperative hyperalimentation
- Recent chemotherapy (within 3 weeks before surgery)
- Previous bowel surgery
- Inflammatory bowel disease
- 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 with in 4 hours before surgery
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394094
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394094
Contacts
| Contact: Manatsawee Manopunya, MD | 66-89-6324916 | manatsawee.m@hotmail.com |
Locations
| Thailand | |
| Faculty of Medicine, Chiang Mai University | Not yet recruiting |
| Amphoe Muang, Chiang Mai, Thailand, 50200 | |
| Contact: Manatsawee Manopunya, MD 66-89-6324916 Manatsawee.m@hotmail.com | |
| Principal Investigator: Manatsawee Manopunya, MD | |
Sponsors and Collaborators
ChaingMai University
Chiang Mai University
Investigators
| Principal Investigator: | Manatsawee - Manopunya, MD | Chiang Mai University, Thailand |
More Information
| Responsible Party: | Manatsawee Manopunya, Chiang Mai University |
| ClinicalTrials.gov Identifier: | NCT01394094 History of Changes |
| Other Study ID Numbers: | 10OCT010402 |
| Study First Received: | July 13, 2011 |
| Last Updated: | July 13, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by ChaingMai University:
|
Gum chewing Bowel function benign gynecologic surgery |
ClinicalTrials.gov processed this record on September 27, 2016