Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer

NCT ID: NCT01389986

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-09-30

Brief Summary

Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol 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: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

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

• Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria

• Perioperative hyperalimentation
• Recent chemotherapy (within 3 weeks before surgery)
• Previous bowel surgery
• Inflammatory bowel diseases
• 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 within 4 hours before surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chiang Mai University

OTHER

Sponsor Role: lead

Responsible Party

Kittipat Charoenkwan, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kittipat Charoenkwan, MD

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Countries

Thailand

Other Identifiers

GUM-ET/OV

Identifier Type: -

Identifier Source: org_study_id