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

NCT06860685 | Not Yet Recruiting Phase 1

• 1 other identifier: SCCHEC-02-2020-059
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (4)

• first flatus time

  time to the passage of first flatus

  end of surgery to first passage of flatus, up to 3 days

• first defecation time

  time to the first defecation

  end of surgery to first passage of defecation, up to 3 days

• proportion of delayed restoration of intestinal motility

  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

  up to 3 days

• length of hospital stay

  up to 30 days (till successful discharge from secondary care to home, up to 30 days)

Study Arms (2)

gum chewing in high-risk group

EXPERIMENTAL

Patients will receive enhanced recovery care and gum chewing (three times per day) on the first postoperative morning until oral dietary intake.

Dietary Supplement: gum chewing

Control in low-risk group

NO INTERVENTION

Patients only receive Enhanced recovery care, including no administration of intestinal antibiotics; normal diet until 6 hours before surgery; no nasogastric drainage; minimal perioprative intravenous fluid; patient started to ambulate and drink water on the first postoperative day

Interventions

gum chewing DIETARY_SUPPLEMENT

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.

gum chewing in high-risk group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed colorectal cancer
• Undergo open or laparoscopic colorectal surgery
• Able to give informed consent
• With normal verbal skills

You may not qualify if:

• Preoperative lower extremity dysfunction
• Dysphagia before surgery
• Patients who are discharged ,transferred to another hospital or die within 72
• hours after surgery

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

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, 610041, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Hui Yang, M.M.

CONTACT

8618908191080; yanghui1@scszlyy.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 6, 2025
• Study Start: March 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)