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

This study is currently recruiting participants.
Verified January 2012 by Chiang Mai University
Sponsor:
Information provided by (Responsible Party):
Kittipat Charoenkwan, M.D., Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01389986
First received: July 5, 2011
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Paralytic Ileus
 Behavioral: Gum chewing
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • Time to first flatus [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: Yes ]
  • Incidence of postoperative complications [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: Yes ]
  • Time to first regular diet [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
  • Time to first defecation [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
  • Postoperative analgesics requirement [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: On the day of hospital discharge, an expected average of 7 days ] [ Designated as safety issue: Yes ]
  • Patients' satisfaction [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389986

Contacts
Contact: Kittipat Charoenkwan, MD 66-81-9920845 kicharoe@med.cmu.ac.th

Locations
Thailand
Faculty of Medicine, Chiang Mai University Recruiting
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Kittipat Charoenkwan, MD Chiang Mai University
  More Information

No publications provided

Responsible Party: Kittipat Charoenkwan, M.D., Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01389986     History of Changes
Other Study ID Numbers: GUM-ET/OV
Study First Received: July 5, 2011
Last Updated: January 4, 2012
Health Authority: Thailand: Research Ethics Committee, Faculty of Medicine, Chiang Mai University

Additional relevant MeSH terms:
Ovarian Neoplasms
Intestinal Pseudo-Obstruction
Adenoma
Ileus
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2013