- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394094
Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery
July 13, 2011 updated by: ChaingMai University
Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial
Gum chewing can promotes the return bowel function after gynecologic surgery.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
124
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Manatsawee Manopunya, MD
- Phone Number: 66-89-6324916
- Email: Manatsawee.m@hotmail.com
Study Locations
-
-
Chiang Mai
-
Amphoe Muang, Chiang Mai, Thailand, 50200
- Faculty of Medicine, Chiang Mai University
-
Contact:
- Manatsawee Manopunya, MD
- Phone Number: 66-89-6324916
- Email: Manatsawee.m@hotmail.com
-
Principal Investigator:
- Manatsawee Manopunya, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Conventional
Conventional postoperative feeding schedule
|
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first flatus
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of postoperative complications
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Time to first regular diet
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Time to first defecation
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Incidence and severity of postoperative nausea, vomiting and abdominal discomfort
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Hospital stay
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Patients's satisfaction
Time Frame: Up to 7 days after surgery
|
Up to 7 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Manatsawee - Manopunya, MD, Chiang Mai University, Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
October 1, 2013
Study Registration Dates
First Submitted
July 13, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Estimate)
July 14, 2011
Last Update Submitted That Met QC Criteria
July 13, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10OCT010402
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Gum chewing
-
Denver Nephrologists, P.C.CM&D Pharma LimitedCompletedChronic Kidney Disease | HyperphosphatemiaUnited States
-
Medical University of ViennaCompletedGestational Diabetes Mellitus in PregnancyAustria
-
Ahmed Salah Ahmed Abd ElgalilCompletedEndotracheal Intubation | Randomized Controlled Trial | Sore Throat | Gum ChewingEgypt
-
Instituto Tecnologico y de Estudios Superiores...Completed
-
University Hospital, LimogesActive, not recruiting
-
Istanbul Demiroglu Bilim UniversityCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Ileus | Gynecologic Disease | Paralytic IleusTurkey
-
State University of New York - Upstate Medical...Terminated
-
Michael Bau MortensenUnknownPancreatic Cancer | Cancer EsophagusDenmark
-
Chiang Mai UniversityCompletedParalytic IleusThailand