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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed colorectal cancer

Undergo open or laparoscopic colorectal surgery

Able to give informed consent

With normal verbal skills

Disqualifiers

Preoperative lower extremity dysfunction

Dysphagia before surgery

Patients who are discharged ,transferred to another hospital or die within 72

hours after surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

292 Participants
are divided into 2 treatment groups
Group A: gum chewing in high-risk groupExperimental treatment 1 intervention
Group B: Control in low-risk groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

first flatus time

time to the passage of first flatus

Time frame
end of surgery to first passage of flatus, up to 3 days
2

first defecation time

time to the first defecation

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

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

Time frame
up to 3 days
4

length of hospital stay

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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