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

Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Paralytic Ileus
• Intervention / Treatment: Behavioral: Gum chewing

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Faculty of Medicine, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
No Intervention: Conventional; Conventional postoperative feeding schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first flatus	Up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort	Up to 7 days after surgery
Incidence of postoperative complications	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
Postoperative analgesics requirement	Up to 7 days after surgery
Hospital stay	On the day of hospital discharge, an expected average of 7 days
Patients' satisfaction	Up to 7 days after surgery

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Kittipat Charoenkwan, MD, Chiang Mai University

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus; Intestinal Pseudo-Obstruction
• Other Study ID Numbers: GUM-ET/OV