Effect of Chewing Gum on Gastrointestinal Function Recovery After Surgery of Gynecological Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Gum Chewing
• Intervention / Treatment: Drug: Gum

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• 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 postopera- tive morning, or bowel anastomosis and upper abdominal multivisceral surgical approaches in relation to the debulking surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gum chewing; Gum 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.	Drug: Gum; no gum
NO_INTERVENTION: Control group; no gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	an expected average of 3 weeks ]

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): January 13, 2020

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (ACTUAL): September 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: RJchewinggum

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No