Effect of Chewing Gum on Gastrointestinal Function Recovery After Surgery of Gynecological Cancer Patients
1 other identifier
interventional
80
1 country
1
Brief Summary
A total patients undergoing abdominal complete surgical staging for various gynecological cancers were randomized into a gum-chewing group or a control group. The patients chewed sugarless gum three times from the first postoperative morning until the first passage of flatus. Each chewing session lasted 30 min. Total abdominal hysterectomy with systematic pelvic and para-aortic lymphad- enectomy was performed on all patients as part of complete staging surgery. Groups were compared in terms of time to first bowel movement time, first flatus and feces pass time, Total length of hospital stay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
October 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedJanuary 14, 2020
October 1, 2018
9 months
September 6, 2018
January 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative flatus pass time
The main outcome variable of the study was postoperative flatus pass time (hours from end of operation). Participants will be followed for the duration of the flatus pass time,
an expected average of 48 hours
Secondary Outcomes (1)
duration of hospital stay
an expected average of 3 weeks ]
Study Arms (2)
Gum chewing
EXPERIMENTALGum type was standardized with all subjects receiving sugar-free peppermint-flavored gum. The patients in the chewing gum group, gum chewing began the morning of postoperative day 1. Patients chewed gum (one stick) 3 times daily in the morning, afternoon, and evening at 30 min. The administration of the therapy was implemented by ward nursing staff and recorded in the patients file. All gum-chewing patients completed their course of gum chewing until bowel function.
Control group
NO INTERVENTIONno gum
Interventions
Eligibility Criteria
You may qualify if:
- Female patients preparing for complete surgical staging for malig- nant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer were assessed for eligibility.
- age 18-60 yr
- good consciousness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajavithi hospital
Bangkok, 10400, Thailand
Related Publications (1)
Ertas IE, Gungorduk K, Ozdemir A, Solmaz U, Dogan A, Yildirim Y. Influence of gum chewing on postoperative bowel activity after complete staging surgery for gynecological malignancies: a randomized controlled trial. Gynecol Oncol. 2013 Oct;131(1):118-22. doi: 10.1016/j.ygyno.2013.07.098. Epub 2013 Jul 29.
PMID: 23906657RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double (Participant, Investigator)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 13, 2018
Study Start
October 6, 2018
Primary Completion
June 30, 2019
Study Completion
January 13, 2020
Last Updated
January 14, 2020
Record last verified: 2018-10