Effect of Xylitol Gum Chewing on Postoperative Bowel Activity

Not Applicable

Completed

• Conditions: Xylitol Gum Chewing; Non-xylitol Gum Chewing; Control Group
• Interventions: Other: xylitol chewing gum

• Registration Number: NCT06579339
• Lead Sponsor: Giresun University

Brief Summary

Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. First flatus, first bowel movement, first defecation, first mobilization time, and discharge time from hospital were recorded. Symptoms included nausea, and vomiting.

Detailed Description

Purpose: Laparoscopic cholecystectomy (LC) has become the standard treatment for gallbladder surgery due to its advantages over open surgery. However, postoperative ileus (POI) remains a common complication. Gum chewing has been proposed to stimulate bowel function post-surgery, but it's unclear whether xylitol in gum influences outcomes. Our objective was to evaluate the effects of postoperative xylitol gum chewing on gastrointestinal functional recovery after laparoscopy.

Design: A Three-Arm Randomized Controlled Trial Methods: Altogether, 75 patients undergoing elective laparoscopy cholecystectomy were randomly divided into 3 groups (final numbers, xylitol chewing gum: 24 controls, xylitol free chewing gum:25 and control 25 patients). Controls underwent a routine postoperative regimen. Both groups chewed gum 3 times a day except the control group. Other postoperative management was routine. The first flatus, first bowel movement, first defecation, first mobilization time, and discharge time from the hospital were recorded. Symptoms included nausea and vomiting.

Study Timeline

• Study Start: 2023-05-05
• Primary Completion: 2024-02-10
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Turkish-speaking,
• Verbal communication,
• Cognitive abilities are normal,
• No psychiatric diagnosis,
• 40 to 65 years old,
• He's having a laparoscopic cholecystectomy,
• ASA (American Society of Anaesthesiologists) Score-I and II,
• who has no problem chewing gum,
• who's going to have scheduled surgery,
• The prescribed duration of surgery not exceeding 100 minutes,
• Patients whose oral intake was to be opened after 6 hours.

Exclusion Criteria

• Having emergency surgery,
• Liver failure,
• Kidney failure,
• Muscle disease
• Those with a known allergy to the anesthesia drugs used and morbidly obese,
• The one with the walking problem,
• The one with the jaw problem,
• Patients who cannot be contacted,
• With a post-operative nasogastric tube,
• Patients whose oral intake would be opened less than 6 hours were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chewing gum with xylitol	xylitol chewing gum	Chewing gum with xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.
Chewing gum with non-xylitol	xylitol chewing gum	Chewing gum with non-xylitol was chewed 3 times a day for 15 minutes. A new chewing gum was chewed by the researcher in each chewing period, chewing gum was stopped at the end of 15 minutes and each quadrant was listened for 15 seconds. The onset of bowel movement was evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the oral cavity at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.

Primary Outcome Measures

Name	Time	Method
Time to first postsurgical flatus, Time to first bowel sound after surgery, Time to first postsurgical defecation, First Mobilization time, Discharge time from hospital	Baseline	The onset of time to first postsurgical flatus, time to first bowel sound after surgery, Time to first postsurgical defecation, first mobilization time, discharge time from hospital were evaluated and all information was recorded in the patient information form and follow-up form. Patients who were discharged without stool output were telephoned and their stool output was questioned. Gum chewing was performed at the 2nd hour, 4th hour and 6th hour postoperatively (due to the opening of the feeding at 6 hours) and the collection of patient data was continued by telephone until discharge and afterwards.

Secondary Outcome Measures

Name	Time	Method
Nausea After Surgery, Vomiting After Surgery	Baseline	Nausea and vomiting were evaluated and all information was recorded.

Trial Locations

Locations (1)

Esra Ozkan; 🇹🇷 Giresun, Piraziz, Turkey