The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section

Paralytic Ileus Clinical Trial

— GUM01  

Official title:

The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01131416
• Other study ID #: 10FEB010938
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 25, 2010
• Last updated: June 27, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant women undergoing cesarean delivery

Exclusion Criteria:

• Perioperative hyperalimentation

• Recent chemotherapy

• Concurrent bowel surgery

• Previous bowel surgery

• Concurrent bowel obstruction

• History of inflammatory bowel diseases

• Previous abdominal/pelvic radiation

• Postoperative placement of endotracheal tube/nasogastric tube

• Postoperative admission to intensive care unit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralytic Ileus

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 addition to conventional postoperative feeding schedule

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative interval until the first flatus		Up to 7 days after delivery	No
Secondary	Postoperative interval until the first passage of stool		Up to 7 days after delivery	No
Secondary	Clinically significant postoperative ileus		Up to 7 days after delivery	No
Secondary	Postoperative hospital stay		Up to 7 days after delivery	Yes
Secondary	Related complications		Up to 7 days after delivery	Yes
Secondary	Patients' satisfaction		Up to 7 days after delivery	No