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

This study is not yet open for participant recruitment.

Verified July 2011 by ChaingMai University

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

Tracking Information

First Received Date ^ICMJE

July 13, 2011

Last Updated Date

July 13, 2011

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to first flatus [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial

Brief Summary

Gum chewing can promotes the return bowel function after gynecologic surgery.

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 ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Recovery of Bowel Function, Due to Gum Chewing

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Behavioral: Gum chewing
No Intervention: Conventional
Conventional postoperative feeding schedule

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

124

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Manatsawee Manopunya, MD

66-89-6324916

manatsawee.m@hotmail.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01394094

Other Study ID Numbers ^ICMJE

10OCT010402

Has Data Monitoring Committee

Yes

Responsible Party

Manatsawee Manopunya, Chiang Mai University

Study Sponsor ^ICMJE

ChaingMai University

Collaborators ^ICMJE

Chiang Mai University

Investigators ^ICMJE

Principal Investigator:

Manatsawee - Manopunya, MD

Chiang Mai University, Thailand

Information Provided By

ChaingMai University

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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