Effect of Xylitol Gum Chewing on Postoperative Bowel Activity
Efficacy of Chewing Xylitol Gum on Restoring Postoperative Bowel Activity After Laparoscopic Cholecystectomy: A Three-Arm Randomised Controlled Trial
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedAugust 30, 2024
April 1, 2024
9 months
August 27, 2024
August 28, 2024
Conditions
Keywords
Outcome Measures
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
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.
Baseline
Secondary Outcomes (1)
Nausea After Surgery, Vomiting After Surgery
Baseline
Study Arms (3)
Chewing gum with xylitol
EXPERIMENTALChewing 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
PLACEBO COMPARATORChewing 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.
Control group
NO INTERVENTIONto standardize the control group patients, all the procedures applied in the intervention group were applied, only the gum was not chewed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Turkish-speaking,
- Verbal communication,
- Cognitive abilities are normal,
- No psychiatric diagnosis,
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Esra Ozkan
Giresun, Piraziz, 28000, Turkey (Türkiye)
Related Publications (17)
Turkay U, Yavuz A, Hortu I, Terzi H, Kale A. The impact of chewing gum on postoperative bowel activity and postoperative pain after total laparoscopic hysterectomy. J Obstet Gynaecol. 2020 Jul;40(5):705-709. doi: 10.1080/01443615.2019.1652891. Epub 2019 Oct 14.
PMID: 31609137BACKGROUNDEdsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
PMID: 27749790BACKGROUNDBrenner P, Kautz DD. Postoperative Care of Patients Undergoing Same-Day Laparoscopic Cholecystectomy. AORN J. 2015 Jul;102(1):16-29; quiz 30-2. doi: 10.1016/j.aorn.2015.04.021.
PMID: 26119606BACKGROUNDNelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PMID: 26757238BACKGROUNDKhalooeifard R, Alemrajabi M, Yazdani SO, Hosseini S. Nutrition Care Process of Surgical Patients in the Context of Enhanced Recovery after Surgery. Nutrition Today. 2022;57(3):145-158. doi:10.1097/NT.0000000000000541
BACKGROUNDKehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PMID: 9175983BACKGROUNDNelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
PMID: 37086524BACKGROUNDUrcanoglu OB, Yildiz T. Effects of Gum Chewing on Early Postoperative Recovery After Laparoscopic Cholecystectomy Surgery: a Randomized Controlled Trial. Indian Journal of Surgery. 2021;83(5):1203-1209. doi:10.1007/s12262-020-02628-7
BACKGROUNDSong GM, Deng YH, Jin YH, Zhou JG, Tian X. Meta-analysis comparing chewing gum versus standard postoperative care after colorectal resection. Oncotarget. 2016 Oct 25;7(43):70066-70079. doi: 10.18632/oncotarget.11735.
PMID: 27588405BACKGROUNDChapman SJ, Pericleous A, Downey C, Jayne DG. Postoperative ileus following major colorectal surgery. Br J Surg. 2018 Jun;105(7):797-810. doi: 10.1002/bjs.10781. Epub 2018 Feb 22.
PMID: 29469195BACKGROUNDArshad R, Bajwa K, Sikander M, Rashid R. The Effectiveness of Bupivacaine Instillation on Postoperative Pain after Elective Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial. the Ulutas Medical Journal. 2019;5(1):26. doi:10.5455/umj.20190130080233
BACKGROUNDTinoco R, Tinoco A, Netto MPS, et al. Iatrogenic Bile Duct Injuries after Cholecystectomy, Is the Laparoscopic Approach a Good Idea? Surgical Science. 2022;13(7):343-351. doi:10.4236/SS.2022.137043
BACKGROUNDIlkaz N, Acavut G, Gençbaş D, Ünal N, Aykan B. Determination of Nursing Diagnoses and Factors Associated with Infections after Laparoscopic Cholecystectomy. University of Health Sciences Journal of Nursing. 2023;5(1):37-44. doi:10.48071/sbuhemsirelik.1203090
BACKGROUNDYaprak M, Doğru V, Mesci A, Akbaş M. Pain Management After Laparoscopic Cholecystectomy. Akdeniz Medical Journal. 2019;5(2):336-341. doi:10.17954/amj.2019.1906
BACKGROUNDStrosberg DS, Nguyen MC, Muscarella P 2nd, Narula VK. A retrospective comparison of robotic cholecystectomy versus laparoscopic cholecystectomy: operative outcomes and cost analysis. Surg Endosc. 2017 Mar;31(3):1436-1441. doi: 10.1007/s00464-016-5134-0. Epub 2016 Aug 5.
PMID: 27495346BACKGROUNDBarutcu AG, Klein D, Kilian M, Biebl M, Raakow R, Pratschke J, Raakow J. Long-term follow-up after single-incision laparoscopic surgery. Surg Endosc. 2020 Jan;34(1):126-132. doi: 10.1007/s00464-019-06739-5. Epub 2019 Mar 12.
PMID: 30863926BACKGROUNDGül A, Cengiz- Açıl H, Aygin D. Current Approaches in Minimally Invasive Surgery. Selçuk Health Journal. 2022;3(1).
BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 30, 2024
Study Start
May 5, 2023
Primary Completion
February 10, 2024
Study Completion
April 1, 2024
Last Updated
August 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share