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Completed

NCT Number: NCT06579339

Effect of Xylitol Gum Chewing on Postoperative Bowel Activity

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.

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Key information

Conditions

Xylitol Gum Chewing Control Group Non-xylitol Gum Chewing

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esra Ozkan

Giresun, Piraziz, 28000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

xylitol chewing gum

Other

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.

Primary outcomes

  1. Time to first postsurgical flatus, Time to first bowel sound after surgery, Time to first postsurgical defecation, First Mobilization time, Discharge time from hospital

    Time frame: 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 outcomes

  1. Nausea After Surgery, Vomiting After Surgery

    Time frame: Baseline

    Nausea and vomiting were evaluated and all information was recorded.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

Efficacy of Chewing Xylitol Gum on Restoring Postoperative Bowel Activity After Laparoscopic Cholecystectomy: A Three-Arm Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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