Gum Chewing Clinical Trial
Official title:
Effect of Chewing Gum on Gastrointestinal Function Recovery After Surgery of Gynecological Cancer Patients at Rajavithi Hospital
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.
This study was conducted from September 2018-September, 2019 at Rajavithi Hospital,
Department of Gynecologic Oncology.
Female patients preparing for complete surgical staging for malignant gynecologic disease
such as endometrial cancer, cervix cancer and ovarian cancer were assessed for eligibility.
Exclusion criteria for the study included thyroid diseases, inflammatory bowel disease,
complaints of chronic constipation (defined as two or fewer bowel movements per week), a
history of prior abdominal bowel surgery, abdominal radiation, or neoadjuvant chemotherapy,
need for intensive care more that 24 h postoperatively, nasogastric tube drainage beyond the
first postoperative morning, or bowel anastomosis and upper abdominal multivisceral surgical
approaches in relation to the debulking surgery.
The study information was explained to all enrolled subjects, informed written consent
obtained and randomization performed as soon as the patients were admitted to the
investigator's gynecologic oncology service. Eligible patients were randomly assigned to one
of two groups by an investigator (I.E.E.) by consecutive opening of sequentially numbered,
opaque, sealed envelopes. Envelope randomization was performed by a blocked of four
randomization method. Group A acted as the control group and received no treatment, and Group
B received sugar-free peppermint-flavored chewing gum.
The same evidence-based protocol of perioperative management, except for chewing gum, was
used for all patients. All patients underwent total abdominal hysterectomy with systematic
pelvic and para- aortic lymph node dissection as part of their staging procedures. The same
surgical team performed all operations.
All subjects received the same postoperative care regimen, All patients were mobilized as
soon as possible in the postoperative period.
To reduce the effects of other variables, the postoperative feeding re- gime was standardized
for the study patients: 30-60 ml of water and if tolerated other liquids were started from
the first postoperative day until the first passage of flatus. Upon passing flatus, clear
fluids and if tolerated semiliquid fiberless diet was allowed. Patients were allowed to
progress to a solid diet according to the patient's toleration or the pas- sage of feces.
Group B began chewing gum on postoperative day one and chewed gum three times daily. Each
chewing lasted 30 min. The administration of therapy was implemented by nursing ward staff
and recorded in the patients file. All gum-chewing patients completed their course of gum
chewing until the return of bowel function.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05069844 -
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|
N/A | |
| Recruiting |
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Phase 4 |