Effect of Xylitol Gum Chewing on Postoperative Bowel Activity

NCT ID: NCT06579339

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2024-04-01

Brief Summary

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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

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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.

Conditions

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Xylitol Gum Chewing Non-xylitol Gum Chewing Control Group

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chewing gum with xylitol

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.

Group Type EXPERIMENTAL

xylitol chewing gum

Intervention Type 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.

Chewing gum with non-xylitol

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.

Group Type PLACEBO_COMPARATOR

xylitol chewing gum

Intervention Type 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.

Control group

to standardize the control group patients, all the procedures applied in the intervention group were applied, only the gum was not chewed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Esra Ozkan

Giresun, Piraziz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31609137 (View on PubMed)

Edsberg 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.

Reference Type BACKGROUND
PMID: 27749790 (View on PubMed)

Brenner 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.

Reference Type BACKGROUND
PMID: 26119606 (View on PubMed)

Nelson 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.

Reference Type BACKGROUND
PMID: 26757238 (View on PubMed)

Khalooeifard 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

Reference Type BACKGROUND

Kehlet 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.

Reference Type BACKGROUND
PMID: 9175983 (View on PubMed)

Nelson 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.

Reference Type BACKGROUND
PMID: 37086524 (View on PubMed)

Urcanoglu 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

Reference Type BACKGROUND

Song 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.

Reference Type BACKGROUND
PMID: 27588405 (View on PubMed)

Chapman 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.

Reference Type BACKGROUND
PMID: 29469195 (View on PubMed)

Arshad 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

Reference Type BACKGROUND

Tinoco 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

Reference Type BACKGROUND

Ilkaz 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

Reference Type BACKGROUND

Yaprak 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

Reference Type BACKGROUND

Strosberg 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.

Reference Type BACKGROUND
PMID: 27495346 (View on PubMed)

Barutcu 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.

Reference Type BACKGROUND
PMID: 30863926 (View on PubMed)

Gül A, Cengiz- Açıl H, Aygin D. Current Approaches in Minimally Invasive Surgery. Selçuk Health Journal. 2022;3(1).

Reference Type BACKGROUND

Other Identifiers

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Xylitol12345

Identifier Type: -

Identifier Source: org_study_id

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