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

Paralytic Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01389986
• Other study ID #: GUM-ET/OV
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: July 5, 2011
• Last updated: August 29, 2016
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: August 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Research Ethics Committee, Faculty of Medicine, Chiang Mai University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intestinal Pseudo-Obstruction
• Ovarian Neoplasms
• 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	Time to first flatus		Up to 7 days after surgery	No
Secondary	Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort		Up to 7 days after surgery	Yes
Secondary	Incidence of postoperative complications		Up to 7 days after surgery	Yes
Secondary	Time to first regular diet		Up to 7 days after surgery	No
Secondary	Time to first defecation		Up to 7 days after surgery	No
Secondary	Postoperative analgesics requirement		Up to 7 days after surgery	No
Secondary	Hospital stay		On the day of hospital discharge, an expected average of 7 days	Yes
Secondary	Patients' satisfaction		Up to 7 days after surgery	No