Colorectal CancerNCT04834661
Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution
An observational study of Colorectal Cancer and Gastric Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer
- What is being tested?
- surgery inside the primary institution and surgery outside the primary institution
- How many people
- 1,130 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: colorectal cancer and gastric cancer
Who may be able to join
- Age between 18 and 100 years
- diagnosed as colorectal cancer or gastric cancer
- undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng
Who cannot join
- Emergency procedure
- without histopathological result of malignancy
- conventional open surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Colorectal Cancer, Gastric Cancer
- Being tested
- surgery inside the primary institution, surgery outside the primary institution
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery inside the primary institutionOther
to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution
surgery outside the primary institutionOther
to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution
| Study group | Role | What they receive |
|---|---|---|
| inside group | laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution Receives: Other: surgery inside the primary institution | |
| outside group | laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution Receives: Other: surgery outside the primary institution |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall postoperative complication rate
postoperative complications evaluated according to Clavin-Dindo classification
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start20 Oct 2021
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
- Investigators
- Zhenghao Cai, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834661
- Sponsor's protocol ID
- multi-sites practice surgery
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04834661
- Acronym / sponsor ID
- multi-sites practice surgery
- Conditions
- Colorectal Cancer, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inside group | – | Other: surgery inside the primary institutionlaparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution |
| outside group | – | Other: surgery outside the primary institutionlaparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- colorectal cancer and gastric cancer
Key inclusion criteria (3 listed)
- Age between 18 and 100 years
- diagnosed as colorectal cancer or gastric cancer
- undergoing laparoscopic surgery between 2016-2020 performed by Dr Feng
Key exclusion criteria (3 listed)
- Emergency procedure
- without histopathological result of malignancy
- conventional open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery inside the primary institutionto perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution | Other | inside group |
| surgery outside the primary institutionto perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution | Other | outside group |
Primary outcome
overall postoperative complication rate
Time frame: 30 days after surgery
postoperative complications evaluated according to Clavin-Dindo classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenghao Cai, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Gastric Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall postoperative complication rate (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.