NCT07796529

Brief Summary

This randomized controlled trial was conducted to evaluate the effect of menthol chewing gum on postoperative nausea and vomiting, bowel function, and recovery in patients undergoing laparoscopic colorectal surgery. A total of 50 patients were randomly assigned to an intervention group (n=25) or a control group (n=25). Participants in the intervention group received menthol chewing gum in addition to standard postoperative care, while participants in the control group received standard postoperative care only. Nausea, bowel function, and postoperative recovery were assessed during the first three postoperative days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 26, 2026

Last Update Submit

August 28, 2026

Conditions

Keywords

Menthol Chewing GumChewing GumLaparoscopic Colorectal SurgeryPostoperative Nausea and VomitingBowel FunctionSurgical RecoveryNonpharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Postoperative Nausea and Vomiting Frequency

    The frequency of postoperative nausea and vomiting was recorded for each participant during the first three postoperative days. Higher values indicate a greater frequency of nausea and vomiting.

    Postoperative days 1, 2, and 3

Secondary Outcomes (1)

  • Postoperative Gas Passage Frequency

    Postoperative days 1, 2, and 3

Other Outcomes (2)

  • Postoperative Defecation Frequency

    [Time Frame: Postoperative days 1, 2, and 3]

  • Postoperative Recovery Status

    Postoperative days 1, 2, and 3

Study Arms (2)

1

EXPERIMENTAL

Menthol Chewing Gum Group

Behavioral: Menthol Chewing Gum

2

NO INTERVENTION

Control Group

Interventions

Participants chewed menthol gum for 30 minutes, followed by a second 30-minute chewing session three hours later. This intervention was repeated on postoperative days 1, 2, and 3 in addition to standard postoperative care.

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60 years
  • Willing to participate in the study
  • At least literate
  • Able to communicate without cognitive, sensory, or verbal impairment
  • No diagnosed psychiatric disorder
  • No vertigo
  • Undergoing elective surgery
  • Not using sedative, anxiolytic, or similar medications
  • Able to speak Turkish
  • Able to chew gum
  • No allergy to menthol or mint
  • No history of jaw or oral surgery

You may not qualify if:

  • Absence of teeth
  • Unwilling to chew gum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Medical Park Gaziosmanpasa Hospital

Istanbul, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either the menthol chewing gum group or the standard care control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 1, 2026

Study Start

January 15, 2024

Primary Completion

April 25, 2024

Study Completion

April 25, 2024

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations