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

NCT01389986 | Withdrawn Phase 2

• 1 other identifier: GUM-ET/OV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to first flatus

  Up to 7 days after surgery

Secondary Outcomes (7)

• 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

Study Arms (2)

Gum chewing

EXPERIMENTAL

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

Conventional

NO INTERVENTION

Conventional postoperative feeding schedule

Interventions

Gum chewing 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

Gum chewing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Faculty of Medicine, Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kittipat Charoenkwan, MD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

TH (1)