Clinical trial NCT06579339: Effect of Xylitol Gum Chewing on Postoperative Bowel Activity
Official title: Efficacy of Chewing Xylitol Gum on Restoring Postoperative Bowel Activity After Laparoscopic Cholecystectomy: A Three-Arm Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xylitol Gum Chewing
Non-xylitol Gum Chewing
Control Group
Keywords: Laparoscopic cholecystectomy
postoperative bowel activity
xylitol gum chewing
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to first postsurgical flatus, Time to first bowel sound after surgery, Time to first postsurgical defecation, First Mobilization time, Discharge time from hospital
timeFrame: Baseline
Secondary outcomes:
measure: Nausea After Surgery, Vomiting After Surgery
timeFrame: Baseline
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Esra Ozkan
state: Piraziz
Study officials:
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