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

Sponsor:

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

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:

MedlinePlus related topics: Bowel Movement

U.S. FDA Resources

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
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

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

No publications provided


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 February 27, 2015

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