Trial of Gum Chewing to Enhance the Restoration of Intestinal Motility in Colorectal Cancer Surgery

NCT06860685 · tracked via the Priya Life Science China tracker

Sponsor

Sichuan Cancer Hospital and Research Institute

Phase

Phase 1/2

Started

2025-03-01

Last updated

2025-03-06

Condition(s) studied

Colorectal Cancer (CRC)

Investigational drug(s) / intervention(s)

gum chewing

gum chewing: Participants allocated to chewing gum will be instructed to chew commercially available sugar-free gum (Extra \& Reg, Wm. Wrigley Jr. Co., Ltd., Shanghai, China) three times daily from the first postoperative morning until oral dietary intake. They were instructed to chew the piece of gum for at least 10 minutes.

Study summary

Surgery is one of the most frequent treatments of colorectal cancer. However, delayed restoration of intestinal motility is a common phenomenon in patients who undergo colorectal surgery, and may reduce comfort, prevent the early hospital discharge of patients and increase healthcare costs. Gum chewing is a kind of safe and easily accessible sham feeding to stimulate intestinal motility. In addition, prediction models were used to estimate the risk of delayed restoration of intestinal motility after colorectal surgery. Thus, this study is an External Controlled trial that will determine whether stratified application of gum chewing by risk prediction model will enhance restoration of intestinal motility and reduce healthcare costs in paitents undergoing open or laparoscopic colorectal surgery.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * Patients with newly diagnosed colorectal cancer * Undergo open or laparoscopic colorectal surgery * Able to give informed consent * With normal verbal skills Exclusion Criteria: * Preoperative lower extremity dysfunction * Dysphagia before surgery * Patients who are discharged ,transferred to another hospital or die within 72 * hours after surgery

Primary outcome measure(s)

first flatus time — end of surgery to first passage of flatus, up to 3 days
time to the passage of first flatus
first defecation time — end of surgery to first passage of defecation, up to 3 days
time to the first defecation
proportion of delayed restoration of intestinal motility — up to 3 days
The proportion of delayed restoration of intestinal motility will be caculated as the number of participants with delayed restoration of intestinal motility divided by the total number of participants enrolled in the study
length of hospital stay — up to 30 days (till successful discharge from secondary care to home, up to 30 days)

Trial sites (1)

Facility	City	Region	Status
Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China	Chengdu	Sichuan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06860685 on ClinicalTrials.gov ↗ ← All trials in China