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

NCT ID: NCT02871245

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-21
• Study Completion Date: 2017-07-31

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.

Conditions

Gastrointestinal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Comparator Group

Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.

Group Type: ACTIVE_COMPARATOR

Laparoscopic Surgery

Intervention Type: PROCEDURE

Acupuncture Therapy Group

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

Group Type: EXPERIMENTAL

Laparoscopic Surgery

Intervention Type: PROCEDURE

Acupuncture treatment

Intervention Type: DEVICE

Interventions

Laparoscopic Surgery

Intervention Type: PROCEDURE

Acupuncture treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiaonan Cui

OTHER

Sponsor Role: lead

Responsible Party

Xiaonan Cui

Professor, Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaonan Cui, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Dalian Medical University

Locations

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaonan Cui, MD, PhD

Role: CONTACT

cxn23@sina.com

+8618098876725

Facility Contacts

Xiaonan Cui, MD, PhD

Role: primary

cxn23@sina.com

+8618098876725

Other Identifiers

LCKY2016-38

Identifier Type: -

Identifier Source: org_study_id