- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447106
Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection. (Cooladvrsigcr)
February 28, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University
An Analysis of Costs and Outcomes Based on the Open, Laparoscopic, and Da Vinci Robotic Approach for Gastric Cancer Resection.
Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment.
Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer.
Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy.
In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer.
Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect.
The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group.
Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- First Affiliated Hospital of Xi'an Jiaotong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients without contraindications gastroscope,surgery and anesthesia;
- There is no history of abdominal surgery, no severe abdominal cavity adhesion
- Patients signed informed consent
Exclusion Criteria:
- Patients with preoperative assessment of distant metastasis;
- Patients with preoperative radiation and chemotherapy or hormone therapy;
- Patients with acute obstruction, bleeding or perforation of the emergency surgery
- Patients with a history of abdominal trauma or abdominal surgery.
- Patients with contraindications gastroscope,surgery and anesthesia;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open
|
This is a kind of traditional surgical method.
|
Experimental: Laparoscopic
|
laparoscopic surgery
|
Experimental: Robotic
|
the Da Vinci robot assisted gastric resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor recurrence rate
Time Frame: 2 years
|
2 years
|
cost of treatment
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the operation time
Time Frame: one hour-six hours
|
one hour-six hours
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jun Jun She, M.D; PhD, First Affiliated Hospital Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 28, 2018
Primary Completion (Anticipated)
February 28, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
February 21, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
March 2, 2018
Last Update Submitted That Met QC Criteria
February 28, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU1AF-CRF-2018-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stomach Neoplasms
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
Chinese University of Hong KongUnknown
-
Chinese University of Hong KongUnknown
-
National Cancer Center, KoreaUnknownSubmucosal Tumor of StomachKorea, Republic of
-
Chinese University of Hong KongRecruiting
-
Universitätsklinikum Hamburg-EppendorfOvesco Endoscopy AGSuspendedSubmucosal Tumor of StomachGermany
-
Xijing Hospital of Digestive DiseasesCompletedStomach Cancer | Esophageal Cancer | Esophageal Dysplasia | Stomach DysplasiaChina
-
Soonchunhyang University HospitalCompletedMalignant Neoplasm of Stomach | Benign Neoplasm of StomachKorea, Republic of
-
Federation Francophone de Cancerologie DigestiveEli Lilly and CompanyActive, not recruitingStomach Cancer | Gastric Cancer | Gastroesophageal Junction Adenocarcinoma | Stomach NeoplasmFrance
-
MedImmune LLCCompletedHER2 Expressing Breast or Gastric/Stomach CancersUnited States
Clinical Trials on laparotomy
-
The University of Texas Health Science Center,...National Center for Advancing Translational Sciences (NCATS)CompletedOther Injury of Other Intra-abdominal Organs, Initial EncounterUnited States
-
Karolinska InstitutetUniversity of StellenboschCompletedPenetrating Abdominal TraumaSouth Africa
-
Inonu UniversityUnknownSmall/Large Bowel
-
University Hospital, GhentJohnson & JohnsonCompleted
-
University of CambridgeNot yet recruitingAbdominal Trauma
-
Assistance Publique - Hôpitaux de ParisRecruitingPreterm Birth | Enterocolitis, NecrotizingFrance
-
Shengjing HospitalNot yet recruiting
-
Turku University HospitalUniversity of Turku; Hormos Medical; VTT Technical Research Centre of Finland; The... and other collaboratorsRecruiting
-
Cardiff and Vale University Health BoardNHS Greater Glasgow and Clyde; The Royal College of Surgeons of EnglandActive, not recruiting
-
EZH EAHCompletedEndometrioma | Endometriosis Ovary | Ruptured EndometriomaTurkey