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

University of Electronic Science and Technology of China (UESTC)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Colorectal Cancer (CRC)

Treatments: Dietary Supplement: gum chewing

Study type: Interventional

Funder types: Other

Identifiers

NCT06860685

SCCHEC-02-2020-059

Details and patient eligibility

About

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.

Full description

Background:

Identifying patients at high risk of delayed restoration of intestinal motility at an early stage and adopting individualized interventions is crucial. The risk prediction model can provide a highly accurate, individualized evidence-based risk estimation by identifying risk factors and creating a risk stratification system. In addition, gum chewing is a kind of sham feeding that has been reported to stimulate intestinal motility and emerged as a popular, simple, safe, effective method for enhancing restoration intestinal motility. Thus, this study combines risk prediction model and gum chewing, aiming to use pre- and intraoperative risk factors to predict the risk of delayed restoration of intestinal motility. After creating a risk stratification system, patients with colorectal surgery will be stratified to high-risk group or low-risk group of delayed restoration of intestinal motility.

Objective:

To compare the efficacy and economics of gum chewing in patients undergoing open or laparoscopic colorectal surgery after stratification by a risk prediction model.

Design:

This is a single-center, two-arm, prospective study and non-randomized external controlled trial.

Subjects:

Two hundred and ninety-two consecutive patients undergoing open or laparoscopic colorectal surgery will be recruited in experiment group, which includes high-risk group and low-risk group.

Interventions:

The low-risk group will only receive enhanced recovery care and the high-risk group will be instructed to chew gum as well as receive enhanced recovery care. The enhanced recovery care consists of no administration of intestinal antibiotics and normal diet until 6 hours before surgery; no nasogastric drainage and minimal perioperative introvenous fluid on the day of surgery; patients start to ambulate and drink water on the first postoperative day. Patients in high-risk group are instructed to chew the piece of sugar-free gum three times (at least 10 minutes) a day from the first postoperative morning until oral dietary intake.

Outcome measures:

The outcomes are first flatus time、first defecation time、Proportion of delayed restoration of intestinal motility、length of hospital stay. All the patients will be assisted to fill in "Patient Log" about the first flatus time and first defecation time after surgery until the oral dietary intake.

Enrollment: 292 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 2 patient groups

gum chewing in high-risk group

Experimental group

Description:

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

Treatment:

Dietary Supplement: gum chewing

Control in low-risk group

No Intervention group

Description:

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