NCT07425249

Brief Summary

Postoperative ileus (POI) is a frequent complication after abdominal surgery, leading to delayed gastrointestinal motility, prolonged hospital stay, and increased patient discomfort. Chewing gum, as a form of sham feeding, has been proposed to stimulate gut motility through vagal stimulation and increased gastrointestinal secretions. This randomized controlled trial aims to assess the effect of chewing gum on early recovery of gastrointestinal motility in patients undergoing open gastrointestinal surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress55%
Jan 2026Oct 2026

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

Postoperative IleusGastrointestinal MotilityEnhanced Recovery After Surgery (ERAS)Postoperative Recovery

Outcome Measures

Primary Outcomes (2)

  • Time to First Passage of Flatus

    Time interval (in hours) from the end of surgery to the first postoperative passage of flatus, assessed by patient self-report and clinical evaluation.

    Within 48 hours postoperatively

  • Time to First Defecation

    Time interval (in hours) from the end of surgery to the first postoperative bowel movement (defecation), assessed by patient self-report and clinical evaluation.

    Within 48 hours postoperatively

Study Arms (2)

Chewing Gum Intervention Group

EXPERIMENTAL

Participants will receive glucose/carbohydrate-containing chewing gum starting 6 hours after surgery. Patients will chew gum for 15 minutes, three times daily, for 48 hours or until first passage of flatus or stool, in addition to standard postoperative care.

Behavioral: Chewing Gum

Standard Care Control Group

NO INTERVENTION

Participants will receive standard postoperative care without chewing gum intervention.

Interventions

Chewing GumBEHAVIORAL

Participants will chew glucose/carbohydrate-containing chewing gum for 15 minutes, three times daily, starting 6 hours after surgery and continuing for 48 hours or until the first passage of flatus or stool, in addition to standard postoperative care.

Chewing Gum Intervention Group

Eligibility Criteria

Age17 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 17 and 85 years.
  • Patients of either gender.
  • Undergoing open gastrointestinal surgical procedures (elective or emergency).
  • Willing to participate and able to provide informed consent.

You may not qualify if:

  • Patients with metabolic or endocrine disorders (diabetes mellitus, hypothyroidism, or hyperthyroidism).
  • Patients with renal disease or electrolyte imbalance.
  • Patients with chronic constipation or neuromuscular disorders.
  • Patients with substance abuse or drug addiction.
  • Patients receiving medications affecting gut motility (calcium channel blockers or antiepileptic drugs).
  • Patients with dental prosthesis or undergoing laparoscopic gastrointestinal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

Related Publications (5)

  • Wells CI, Milne TGE, Seo SHB, Chapman SJ, Vather R, Bissett IP, O'Grady G. Post-operative ileus: definitions, mechanisms and controversies. ANZ J Surg. 2022 Jan;92(1-2):62-68. doi: 10.1111/ans.17297. Epub 2021 Oct 22.

    PMID: 34676664BACKGROUND
  • Ge W, Chen G, Ding YT. Effect of chewing gum on the postoperative recovery of gastrointestinal function. Int J Clin Exp Med. 2015 Aug 15;8(8):11936-42. eCollection 2015.

    PMID: 26550107BACKGROUND
  • 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
  • Lew SL, Cheng LJ, Yap SY, Liaw YQ, Park J, Lau ST. Effect of chewing gum on clinical outcomes and postoperative recovery in adult patients after gastrointestinal surgery: an umbrella review. Int J Surg. 2025 May 1;111(5):3481-3493. doi: 10.1097/JS9.0000000000002332.

    PMID: 40072350BACKGROUND
  • Roslan F, Kushairi A, Cappuyns L, Daliya P, Adiamah A. The Impact of Sham Feeding with Chewing Gum on Postoperative Ileus Following Colorectal Surgery: a Meta-Analysis of Randomised Controlled Trials. J Gastrointest Surg. 2020 Nov;24(11):2643-2653. doi: 10.1007/s11605-019-04507-3. Epub 2020 Feb 26.

    PMID: 32103455BACKGROUND

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dr Ali Raza, MBBS

    Khyber Teaching Hospital

    PRINCIPAL INVESTIGATOR
  • Dr Munir Ahmed, FCPS

    Khyber Teaching Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Ali Raza, MBBS

CONTACT

Dr Munir Ahmed, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study. Neither participants nor investigators are blinded due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to two parallel groups. An intervention group receiving chewing gum and a control group receiving standard postoperative care without chewing gum.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 20, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

October 29, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) related to study outcomes, baseline characteristics, and statistical analyses will be shared with qualified researchers upon reasonable request, after publication of the primary study results. Data will be shared to promote transparency and facilitate further research while ensuring participant confidentiality.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access Criteria
Access to de-identified IPD will be granted to researchers who provide a methodologically sound research proposal, with approval from the principal investigator and institutional ethical review board. A data use agreement will be required prior to data sharing.

Locations