Trial record 2 of 16 for:    Open Studies | "Defecation"

Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by ChaingMai University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Chiang Mai University
Information provided by:
ChaingMai University
ClinicalTrials.gov Identifier:
NCT01394094
First received: July 13, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

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


Condition Intervention Phase
Recovery of Bowel Function, Due to Gum Chewing
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 Benign Gynecologic Surgery: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by ChaingMai 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 ]
  • Hospital stay [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]
  • Patients's satisfaction [ Time Frame: Up to 7 days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: July 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 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 the addition to conventional postoperative feeding schedule
Other Name: Sugar free and calcium free gum
No Intervention: Conventional
Conventional postoperative feeding schedule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394094

Contacts
Contact: Manatsawee Manopunya, MD 66-89-6324916 manatsawee.m@hotmail.com

Locations
Thailand
Faculty of Medicine, Chiang Mai University Not yet recruiting
Amphoe Muang, Chiang Mai, Thailand, 50200
Contact: Manatsawee Manopunya, MD    66-89-6324916    Manatsawee.m@hotmail.com   
Principal Investigator: Manatsawee Manopunya, MD         
Sponsors and Collaborators
ChaingMai University
Chiang Mai University
Investigators
Principal Investigator: Manatsawee - Manopunya, MD Chiang Mai University, Thailand
  More Information

No publications provided

Responsible Party: Manatsawee Manopunya, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01394094     History of Changes
Other Study ID Numbers: 10OCT010402
Study First Received: July 13, 2011
Last Updated: July 13, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by ChaingMai University:
Gum chewing
Bowel function
benign gynecologic surgery

ClinicalTrials.gov processed this record on April 17, 2014