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

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

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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