The Role of TCM on ERAS of Rectal Cancer Patients

Peking University Cancer Hospital & Institute264 enrolled

Overview

This study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients.

The hypothesis is that TCM can decrease the postoperative complications for rectal cancer. So the study is to investigate the role of traditional Chinese medicine (TCM) on the postoperative recovery of rectal cancer patients. Patients enrolled in this study will be randomized into two groups with TCM intervention or placebo. The intervention will be described below. Primary endpoint is postoperative complications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

264

Conditions

Rectal Cancer

Interventions

acupoint with TCMCOMBINATION_PRODUCT

The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.

acupoint with placeboCOMBINATION_PRODUCT

The placebo acupoint application was made of black beans and honey, which shares the similar shape and smell of the experiment group, applied at the same acupoints.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written consent form; * Age from 18 to 75 years old; * Pathological diagnosis as rectal adenocarcinoma; * undergo laparoscopic curative surgery; * Patients' TCM syndrome accords with thoses of spleen deficiency syndrome; Exclusion Criteria: * Patients undergo non-curative surgeries; * Participants with skin allergy, skin ulceration and diabetes mellitus with poor glycemic control; * Participants with severe dysfunction of heart, liver and kidney, who could not receive TCM treatment; * Women who are pregnant or breastfeeding; * Participants have mental illness or have difficulty in language communication and are unable to complete the study; * Participants could not cooperate with this researcher for other reasons.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Postoperative complications

Rates of the complications after curative surgery

Time frame: from operation to 30 days after operation

Secondary Outcomes

recovery of urinary function

The rates of urinary retention after removal of urinary catheter

Time frame: from removal of urinary catheter to 30 days after operation

Recovery of fart and bowel function

The time of the first tart and first defecation after operation in days

Time frame: 7 days after operation

The European Organization of Quality of Life Questionnaire-colorectal-29

Cancer Quality of Life Questionnaire-Colorectal-29, with scale from 1 to 4 for each items as QOL becomes poorer.

Time frame: 30 days after operation

Changes of TCM symptoms

Changes of traditional Chinese medicine symptoms: all symptoms were recorded by 10 simple questions and then will be categorized in 4 different groups. The aim of study tries to show the relationship with TCM application with the symptoms.

Time frame: 30 days after operation

Length of hospital stay

Time of hospital stay in days

Time frame: 30 days after operation

Central Contacts

Nan Chen, M.D.;Ph.D

CONTACT

+86 18911956939 chennanpku@126.com

Data from ClinicalTrials.gov

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