Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery

Not Applicable

• Conditions: Gastrointestinal Neoplasms
• Interventions: Procedure: Laparoscopic Surgery; Device: Acupuncture treatment

• Registration Number: NCT02871245
• Lead Sponsor: Xiaonan Cui

Brief Summary

Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle section of the rectum will be as the research object. Cancer patients are diagnosed based on pathology or cell biology. The trial is randomized, parallel and open. They are randomized into 2 groups: both groups receive surgery. The experimental group receives conventional treatment combine with electroacupuncture Zusanli point .etc finish operation and the contrast receives the same conventional treatment with experimental group. Clinical evaluation includes gastrointestinal tract recovery of function, pain relief, life quality improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone, peroxidatic reaction and the ratio of immune cells.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-14
• Study First Posted: 2016-08-18
• Study Start: 2016-09-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Weight: 40kg-90kg, male and female.
• Diagnosis: imaging, cell and pathology report.
• Brain, heart, lung, liver, kidney are at good condition in 2 weeks before surgery.
• No conscious obstacle and limbs disability.

Exclusion Criteria

• Fainting during acupuncture.
• Electrolyte imbalance.
• Serious and life-threatening complications after surgery.
• In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture Therapy Group	Acupuncture treatment	Patients received gastrointestinal neoplasms laparoscopic surgery and acupuncture therapy. Finish surgery up to 24 hours electricity acupuncture treatment, treatment 1 times a day, every time lasted 30 minutes, 5 days in a row
Comparator Group	Laparoscopic Surgery	Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.
Acupuncture Therapy Group	Laparoscopic Surgery	Patients received gastrointestinal neoplasms laparoscopic surgery and acupuncture therapy. Finish surgery up to 24 hours electricity acupuncture treatment, treatment 1 times a day, every time lasted 30 minutes, 5 days in a row

Primary Outcome Measures

Name	Time	Method
Number of participants and classification with operation-related adverse events as assessed by CTCAE v4.03.	day 1, day 3, day 5, day 7 after surgery

Secondary Outcome Measures

Name	Time	Method
The quality of life questionnaire(QLQ).	day 1, day 3, day 5, day 7 after surgery	Assessing in 5 grade, mainly include appetite, sleep, pain,etc.
Stress hormone in blood.	day 2, day 7 after surgery	Estradiol (female), progesterone (female), testosterone (male)
Immune cell number ratio in blood.	day 2, day 7 after surgery	Th1/Th2, Th17/Treg

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China