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Clinical Trials/NCT01394094
NCT01394094UnknownPhase 2

Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery: a Randomized Controlled Trial

Chiang Mai University1 site in 1 country124 target enrollmentStarted: July 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Enrollment
124
Locations
1
Primary Endpoint
Time to first flatus

Study Overview

Brief Summary

Gum chewing can promotes the return bowel function after gynecologic surgery.

Detailed Description

Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria

  • •Perioperative hyperalimentation
  • •Recent chemotherapy (within 3 weeks before surgery)
  • •Previous bowel surgery
  • •Inflammatory bowel disease
  • •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 with in 4 hours before surgery

Arms & Interventions

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

Intervention: Gum chewing (Behavioral)

Conventional

No Intervention

Conventional postoperative feeding schedule

Outcomes

Primary Outcomes

Time to first flatus

Time Frame: Up to 7 days after surgery

Secondary Outcomes

  • Time to first defecation(Up to 7 days after surgery)
  • Hospital stay(Up to 7 days after surgery)
  • Patients's satisfaction(Up to 7 days after surgery)
  • 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)

Investigators

Sponsor Class
Other

Study Sites (1)

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