NCT02871245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 21, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

August 7, 2016

Last Update Submit

April 13, 2017

Conditions

Gastrointestinal Neoplasms

Keywords

Acupuncture TherapyLaparoscopic SurgeryGastrointestinal Tract Recovery of Function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The quality of life questionnaire(QLQ).

    day 1, day 3, day 5, day 7 after surgery

  • Stress hormone in blood.

    day 2, day 7 after surgery

  • Immune cell number ratio in blood.

    day 2, day 7 after surgery

Study Arms (2)

Comparator Group

ACTIVE COMPARATOR

Patients received gastrointestinal neoplasms laparoscopic surgery but no acupuncture therapy.

Procedure: Laparoscopic Surgery

Acupuncture Therapy Group

EXPERIMENTAL

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

Procedure: Laparoscopic SurgeryDevice: Acupuncture treatment

Interventions

Laparoscopic SurgeryPROCEDURE
Acupuncture Therapy GroupComparator Group
Acupuncture treatmentDEVICE
Acupuncture Therapy Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

LaparoscopyAcupuncture Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeComplementary TherapiesTherapeutics

Study Officials

  • Xiaonan Cui, MD, PhD

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaonan Cui, MD, PhD

CONTACT

+8618098876725cxn23@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Chief physician

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 18, 2016

Study Start

September 21, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

CN(1)