NCT06579339

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

August 30, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

August 27, 2024

Last Update Submit

August 28, 2024

Conditions

Keywords

Laparoscopic cholecystectomypostoperative bowel activityxylitol gum chewing

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

EXPERIMENTAL

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.

Other: xylitol chewing gum

Chewing gum with non-xylitol

PLACEBO COMPARATOR

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.

Other: xylitol chewing gum

Control group

NO INTERVENTION

to 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.

Chewing gum with non-xylitolChewing gum with xylitol

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 31609137BACKGROUND
  • 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.

    PMID: 27749790BACKGROUND
  • 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.

    PMID: 26119606BACKGROUND
  • 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.

    PMID: 26757238BACKGROUND
  • 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

    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.

    PMID: 9175983BACKGROUND
  • 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.

    PMID: 37086524BACKGROUND
  • 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

    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.

    PMID: 27588405BACKGROUND
  • 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.

    PMID: 29469195BACKGROUND
  • 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

    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

    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

    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

    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.

    PMID: 27495346BACKGROUND
  • 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.

    PMID: 30863926BACKGROUND
  • Gül 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

Locations