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

Recovery of Bowel Function, Due to Gum Chewing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01394094
• Other study ID #: 10OCT010402
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: July 13, 2011
• Last updated: July 13, 2011
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: July 2011
• Source: ChaingMai University
• Contact: Manatsawee Manopunya, MD
• Phone: 66-89-6324916
• Email: manatsawee.m[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Recovery of Bowel Function, Due to Gum Chewing

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chiang Mai University	Amphoe Muang	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
ChaingMai University	Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first flatus		Up to 7 days after surgery	No
Secondary	Incidence and severity of postoperative nausea, vomiting and abdominal discomfort		Up to 7 days after surgery	Yes
Secondary	Incidence of postoperative complications		Up to 7 days after surgery	Yes
Secondary	Time to first regular diet		Up to 7 days after surgery	No
Secondary	Time to first defecation		Up to 7 days after surgery	No
Secondary	Hospital stay		Up to 7 days after surgery	No
Secondary	Patients's satisfaction		Up to 7 days after surgery	No