ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01394094
Recruitment Status : Unknown
Verified July 2011 by ChaingMai University.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2011
Last Update Posted : July 14, 2011
Sponsor:
Collaborator:
Chiang Mai University
Information provided by:
ChaingMai University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Gum chewing can promotes the return bowel function after gynecologic surgery.

Condition or disease Intervention/treatment Phase
Recovery of Bowel Function, Due to Gum Chewing Behavioral: Gum chewing Phase 2 Phase 3

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 Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : July 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Time to first flatus [ Time Frame: Up to 7 days after surgery ]

Secondary Outcome Measures :
  1. Incidence and severity of postoperative nausea, vomiting and abdominal discomfort [ Time Frame: Up to 7 days after surgery ]
  2. Incidence of postoperative complications [ Time Frame: Up to 7 days after surgery ]
  3. Time to first regular diet [ Time Frame: Up to 7 days after surgery ]
  4. Time to first defecation [ Time Frame: Up to 7 days after surgery ]
  5. Hospital stay [ Time Frame: Up to 7 days after surgery ]
  6. Patients's satisfaction [ Time Frame: Up to 7 days after surgery ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Manatsawee Manopunya, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01394094     History of Changes
Other Study ID Numbers: 10OCT010402
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: July 14, 2011
Last Verified: July 2011

Keywords provided by ChaingMai University:
Gum chewing
Bowel function
benign gynecologic surgery