- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04834661
Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution
April 15, 2022 updated by: Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
Safety and Feasibility of Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution Under Multi-sites Practice (MSP) Policy, a Retrospective Comparative Study
This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy.
This is a single practitioner, retrospective comparative study.
The endpoints are peri-operative outcomes, pathological results, and medical costs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1130
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
-
-
Shanghai
-
Shanghai, Shanghai, China, 200020
- Ruijin Hospital
-
-
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
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
colorectal cancer and gastric cancer
Description
Inclusion Criteria:
- Age between 18 and 100 years
- diagnosed as colorectal cancer or gastric cancer
- undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng
Exclusion Criteria:
- Emergency procedure
- without histopathological result of malignancy
- conventional open surgery
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
inside group
laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution
|
to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution
|
outside group
laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution
|
to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall postoperative complication rate
Time Frame: 30 days after surgery
|
postoperative complications evaluated according to Clavin-Dindo classification
|
30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhenghao Cai, MD, Ruijin Hospital
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 (Actual)
October 20, 2021
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 4, 2021
First Submitted That Met QC Criteria
April 4, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2022
Last Update Submitted That Met QC Criteria
April 15, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- multi-sites practice surgery
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.
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