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

NCT ID: NCT01131416

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-06-30

Brief 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.

Conditions

Paralytic Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Gum chewing

Intervention Type: BEHAVIORAL

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

Conventional

Conventional postoperative feeding schedule

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Faculty of Medicine, Chiang Mai University

Principal Investigators

Kittipat Charoenkwan, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiang Mai University

Locations

Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Countries

Thailand

Other Identifiers

10FEB010938

Identifier Type: -

Identifier Source: org_study_id