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

Phase 2

Withdrawn

• Conditions: Paralytic Ileus
• Interventions: Behavioral: Gum chewing

• Registration Number: NCT01389986
• Lead Sponsor: Chiang Mai University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gum chewing	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

Primary Outcome Measures

Name	Time	Method
Time to first flatus	Up to 7 days after surgery

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	Up to 7 days after surgery
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort	Up to 7 days after surgery
Time to first regular diet	Up to 7 days after surgery
Time to first defecation	Up to 7 days after surgery
Hospital stay	On the day of hospital discharge, an expected average of 7 days
Incidence of postoperative complications	Up to 7 days after surgery
Postoperative analgesics requirement	Up to 7 days after surgery

Trial Locations

Locations (1)

Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand