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NCT04834661 Clinical Trial

Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution

Colorectal Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04834661
Other study ID # multi-sites practice surgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date December 31, 2021

Study information
Verified date April 2022
Source Shanghai Minimally Invasive Surgery Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1130
Est. completion date December 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• surgery inside the primary institution
to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution
• surgery outside the primary institution
to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution

Locations
Country Name City State
China Ruijin Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Minimally Invasive Surgery Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall postoperative complication rate postoperative complications evaluated according to Clavin-Dindo classification 30 days after surgery
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