NCT06029790

Brief Summary

False feeding refers to promoting gastrointestinal peristalsis by seeing, smelling, chewing, and tasting food, not getting food into the gastrointestinal tract. Postoperative sham feeding uses gum to promote the healing of gastrointestinal peristalsis. Although not fully understood, the physiological theory underlying gum chewing (fake feeding) to stimulate peristalsis and reduce postoperative intestinal recovery time is that the oral and chewing stimulation provided by chewing gum stimulates a neurohumoral reflex that increases gastrointestinal fluid secretion. This increases gastrointestinal motility. In addition, oral stimulation and chewing can stimulate the vagus nerve, which is also involved in promoting peristalsis. Finally, none of the existing theories adequately explain the effect of chewing/gum chewing on reducing postoperative inflammation in the gut, which may result in a reduced incidence of postoperative infection. In previous studies, physiological changes associated with gum appear to promote normal gastrointestinal function and subsequent postoperative/anesthetic recovery. Although many studies have been conducted to examine the effectiveness of chewing gum in patients undergoing colorectal resection, the results have been inconsistent. This can be attributed to differences in intestinal injuries affecting bowel function, differences in time under anesthesia and differences in anesthetics or pain control agents used for pain control affecting bowel function, and recovery time of peristalsis. Given the many factors known to affect postoperative ileus, chewing gum as an intervention remains a safe, accessible, and inexpensive option that remains to be explored.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

August 28, 2023

Last Update Submit

March 12, 2026

Conditions

Keywords

postsurgical ileuschewing gumcolorectal surgery

Outcome Measures

Primary Outcomes (2)

  • prevention of postoperative ileus

    The first postoperative gas removal time and the first postoperative stool removal time will be questioned by the researcher. There is no standard scale for this.

    72 hours

  • Prevention of nausea-vomiting.

    Nausea and Vomiting Evaluation Form. In our study, PONV status will be evaluated as "Yes/No" at 0, 2, 4, 8, 12 and 24 hours using the Nausea and Vomiting Evaluation Form.

    72 saat

Study Arms (2)

gum chewing

EXPERIMENTAL

All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. For the patients in the experimental group, sugar-free xylitol gum containing 1.2-1.37 grams of xylitol per piece, available in the market, will be used. Participants in the experimental group will start chewing gum on the first postoperative day and will be allowed to chew a single piece of gum 3 times a day at 9:00, 14:00 and 19:00, respectively, for 15 minutes. The gum will be given to the participants regularly by a researcher until the first reported flatulence.

Other: gum chewing

control group

NO INTERVENTION

All participants will receive standard postoperative care, 2 L/min of oxygen delivered via nasal cannula if oxygen saturation is below 95%. In addition, participants will be encouraged to use the incentive spirometer 10 times per hour to prevent respiratory complications such as pneumonia. In the postoperative period, all participants will be removed from bed and mobilized as soon as possible. The control group will receive only standard care.

Interventions

For the patients in the experimental group, sugar-free xylitol gum containing 1.2-1.37 grams of xylitol per piece, available in the market, will be used. Participants in the experimental group will start chewing gum on the first postoperative day and will be allowed to chew a single piece of gum 3 times a day at 9:00, 14:00 and 19:00, respectively, for 15 minutes. The gum will be given to the participants regularly by a researcher until the first reported flatulence.

gum chewing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To have applied for elective colorectal surgery,
  • Having undergone laparoscopic colorectal surgery,
  • Not having a nasogastric insertion,
  • Not having a vision-hearing problem,
  • ECOG performance score to be between 0-2,

You may not qualify if:

  • Performing emergency surgical intervention,
  • Open colorectal surgery
  • Need for intensive care after surgery,
  • Stoma has been opened

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

Related Publications (12)

  • van den Heijkant TC, Costes LM, van der Lee DG, Aerts B, Osinga-de Jong M, Rutten HR, Hulsewe KW, de Jonge WJ, Buurman WA, Luyer MD. Randomized clinical trial of the effect of gum chewing on postoperative ileus and inflammation in colorectal surgery. Br J Surg. 2015 Feb;102(3):202-11. doi: 10.1002/bjs.9691. Epub 2014 Dec 18.

    PMID: 25524125BACKGROUND
  • Yang P, Long WJ, Wei L. Chewing Xylitol Gum could Accelerate Bowel motility Recovery after Elective Open Proctectomy for Rectal Cancer. Rev Invest Clin. 2018;70(1):53-58. doi: 10.24875/RIC.18002428.

    PMID: 29513303BACKGROUND
  • Liu Q, Jiang H, Xu D, Jin J. Effect of gum chewing on ameliorating ileus following colorectal surgery: A meta-analysis of 18 randomized controlled trials. Int J Surg. 2017 Nov;47:107-115. doi: 10.1016/j.ijsu.2017.07.107. Epub 2017 Sep 1.

    PMID: 28867465BACKGROUND
  • Hsu YC, Szu SY. Effects of Gum Chewing on Recovery From Postoperative Ileus: A Randomized Clinical Trail. J Nurs Res. 2022 Oct 1;30(5):e233. doi: 10.1097/jnr.0000000000000510.

    PMID: 35951432BACKGROUND
  • Lee JT, Hsieh MH, Cheng PJ, Lin JR. The Role of Xylitol Gum Chewing in Restoring Postoperative Bowel Activity After Cesarean Section. Biol Res Nurs. 2016 Mar;18(2):167-72. doi: 10.1177/1099800415592966. Epub 2015 Jul 7.

    PMID: 26156002BACKGROUND
  • Forrester DA, Doyle-Munoz J, McTigue T, D'Andrea S, Natale-Ryan A. The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial. J Wound Ostomy Continence Nurs. 2014 May-Jun;41(3):227-32. doi: 10.1097/WON.0000000000000019.

    PMID: 24621587BACKGROUND
  • Kobayashi T, Masaki T, Kogawa K, Matsuoka H, Sugiyama M. Efficacy of Gum Chewing on Bowel Movement After Open Colectomy for Left-Sided Colorectal Cancer: A Randomized Clinical Trial. Dis Colon Rectum. 2015 Nov;58(11):1058-63. doi: 10.1097/DCR.0000000000000452.

    PMID: 26445178BACKGROUND
  • Suh SY, Leblanc TW, Shelby RA, Samsa GP, Abernethy AP. Longitudinal patient-reported performance status assessment in the cancer clinic is feasible and prognostic. J Oncol Pract. 2011 Nov;7(6):374-81. doi: 10.1200/JOP.2011.000434.

    PMID: 22379420BACKGROUND
  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PMID: 7165009BACKGROUND
  • Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

    PMID: 10485781BACKGROUND
  • Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

    PMID: 30426190BACKGROUND
  • Gezer D, Alptekin D, Yalav O, Eray IC. Effect of gum chewing on the return of bowel sounds, time to first flatus, and defecation after colorectal cancer surgery: A prospective, randomized controlled trial. Eur J Oncol Nurs. 2025 Dec;79:103039. doi: 10.1016/j.ejon.2025.103039. Epub 2025 Nov 7.

Related Links

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a prospective, single-blind, parallel-group, randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profesor

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 8, 2023

Study Start

January 10, 2024

Primary Completion

June 20, 2024

Study Completion

August 19, 2024

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Results on the effects of chewing gum on nausea, vomiting and bowel functions after colorectal surgery will be shared. However, personal information will not be shared.

Locations