Colon CancerSTARS-CC01NCT04853784
Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
An observational study of Colon Cancer and Surgery, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Surgery, Totally Laparoscopic
- What is being tested?
- intracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 May 2023
- How long will I take part?
- 1 Month
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colon cancer
Who may be able to join
- Age: 18-80 years old, male or female;
- Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
- The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;
- 5. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.
Who cannot join
- Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Neighboring organs need to be combined with organ resection;
- New adjuvant therapy before surgery;
- ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
- Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
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- History of severe mental illness;
- Pregnant or lactating women;
- Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
This is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations
Read the detailed description
Colorectal cancer is one of the most common malignant tumors in China. With the advancement of medical science and technology, the treatment of colorectal cancer has become more mature, forming a comprehensive and individualized treatment model focusing on surgery. The promotion of the principles of TME and CME surgery has greatly standardized the operation of colorectal surgery. COLOR II, COREAN and CLASICC studies have all confirmed the safety and effectiveness of laparoscopic colorectal cancer surgery.
In traditional laparoscopic-assisted surgery, a small incision in the abdominal wall is used to assist in trimming the mesangium to remove the specimen, and the anastomosis is completed outside the abdominal wall, which will still cause postoperative incision pain and may lead to complications such as incisional infection and incisional hernia. However, in some obese patients, the mesangium is thick and short. The above operations are more difficult, and may even cause the risk of mesangial tears and bleeding, which will weaken the minimally invasive advantages of laparoscopic surgery.
The total laparoscopic radical resection of colon cancer is performed under laparoscopic free dissection and dissected reconstruction of the operation area. The small incision of the abdominal wall Trocar is used to take out the specimen, which not only guarantees a sufficient range of dissection and resection, but also avoids the troubles caused by the auxiliary abdominal wall incision. Postoperative recovery may be faster, but it also raises questions about the increased risk of infection in the surgical area. Total laparoscopic radical resection of colon cancer still lacks corresponding high-quality clinical research. In response to this problem, this study compares related surgical methods, verifies the safety and effectiveness of the corresponding surgical methods, and provides better guidance for subsequent clinical practice.
Taking laparoscopic-assisted radical resection of colon cancer as a control, the short-term and long-term effects of full laparoscopic radical resection of colon cancer were evaluated, so as to choose a more effective and safe operation method.
- Being tested
- intracorporeal anastomosis
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracorporeal anastomosisProcedure or surgery
Also called extracorporeal anastomosis
intracorporeal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Totally laparoscopic colon surgery | Totally laparoscopic colon surgery/intracorporeal anastomosis Receives: Procedure: intracorporeal anastomosis | |
| Laparoscopic-assited colon surgery | Laparoscopic-assited colon surgery/extracorporeal anastomosis Receives: Procedure: intracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
Complication incidence 30 days after operation
Measured: 30 days after operation
Secondary outcomes (9)
Operation time
the length between the beginning and the end of the whole operation
Measured: one hour after surgery
number of lymphnodes dissected
one week after surgery
Measured: During the operation
Length of surgical incision
Length of surgical incision
Measured: one week after surgery
Intraoperative blood loss
the mount of blood loss during the whole operation(ml）
Measured: one hour after surgery
Intraoperative conversion rate
Intraoperative conversion rate (conversion to open, conversion to laparoscopic-assisted surgery
Measured: one hour after surgery
Rate of complete mesentery resection (CME)
Rate of complete mesentery resection (CME)
Measured: one week after surgery
Postoperative recovery
Postoperative recovery: first exhaust, defecation time, restoring liquid diet, hospitalization days.
Measured: During the postoperative hospital stay
3-year disease-free survival
3-year disease-free survival
Measured: 3 years after operation
5-year overall survival OS
5-year overall survival OS
Measured: 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Wang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853784
- Sponsor's protocol ID
- STARS-CC01
- Acronym
- STARS-CC01
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registration Study of Totally Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery
- ClinicalTrials.gov ID
- NCT04853784
- Acronym / sponsor ID
- STARS-CC01 / STARS-CC01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 21 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 is a comparison of totally laparoscopic and laparoscopic-assisted colon cancer resection, a prospective registration study comparing the safety and benefits of the two operations
Detailed description
Colorectal cancer is one of the most common malignant tumors in China. With the advancement of medical science and technology, the treatment of colorectal cancer has become more mature, forming a comprehensive and individualized treatment model focusing on surgery. The promotion of the principles of TME and CME surgery has greatly standardized the operation of colorectal surgery. COLOR II, COREAN and CLASICC studies have all confirmed the safety and effectiveness of laparoscopic colorectal cancer surgery.
In traditional laparoscopic-assisted surgery, a small incision in the abdominal wall is used to assist in trimming the mesangium to remove the specimen, and the anastomosis is completed outside the abdominal wall, which will still cause postoperative incision pain and may lead to complications such as incisional infection and incisional hernia. However, in some obese patients, the mesangium is thick and short. The above operations are more difficult, and may even cause the risk of mesangial tears and bleeding, which will weaken the minimally invasive advantages of laparoscopic surgery.
The total laparoscopic radical resection of colon cancer is performed under laparoscopic free dissection and dissected reconstruction of the operation area. The small incision of the abdominal wall Trocar is used to take out the specimen, which not only guarantees a sufficient range of dissection and resection, but also avoids the troubles caused by the auxiliary abdominal wall incision. Postoperative recovery may be faster, but it also raises questions about the increased risk of infection in the surgical area. Total laparoscopic radical resection of colon cancer still lacks corresponding high-quality clinical research. In response to this problem, this study compares related surgical methods, verifies the safety and effectiveness of the corresponding surgical methods, and provides better guidance for subsequent clinical practice.
Taking laparoscopic-assisted radical resection of colon cancer as a control, the short-term and long-term effects of full laparoscopic radical resection of colon cancer were evaluated, so as to choose a more effective and safe operation method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Totally laparoscopic colon surgery | – | Procedure: intracorporeal anastomosisTotally laparoscopic colon surgery/intracorporeal anastomosis |
| Laparoscopic-assited colon surgery | – | Procedure: intracorporeal anastomosisLaparoscopic-assited colon surgery/extracorporeal anastomosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon cancer
Key inclusion criteria (4 listed)
- Age: 18-80 years old, male or female;
- Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
- The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;
- 5. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.
Key exclusion criteria (9 listed)
- Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
- Neighboring organs need to be combined with organ resection;
- New adjuvant therapy before surgery;
- ASA grade ≥ grade IV and/or ECOG physical status score> 2 points;
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 |
|---|---|---|
| intracorporeal anastomosisAlso: extracorporeal anastomosisintracorporeal anastomosis | Procedure or surgery | Laparoscopic-assited colon surgery, Totally laparoscopic colon surgery |
Primary outcome
Incidence of postoperative complications
Time frame: 30 days after operation
Complication incidence 30 days after operation
9 secondary outcomes
Operation time
Time frame: one hour after surgery
number of lymphnodes dissected
Time frame: During the operation
Length of surgical incision
Time frame: one week after surgery
Intraoperative blood loss
Time frame: one hour after surgery
Intraoperative conversion rate
Time frame: one hour after surgery
Rate of complete mesentery resection (CME)
Time frame: one week after surgery
Postoperative recovery
Time frame: During the postoperative hospital stay
3-year disease-free survival
Time frame: 3 years after operation
5-year overall survival OS
Time frame: 5 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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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.
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 Colon Cancer and Surgery, run by The First Hospital of Jilin University 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quan Wang, Prof. (15843073207, wquan@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: 30 days after operation). 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 21 Apr 2021.