Colorectal CancerC-PelvEx-01NCT05707598
Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches
An observational study of Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 638 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 11 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. The patients were diagnosed with colorectal cancer and the tumor was considered to have invaded the adjacent organs before surgery. 2. The patient experienced multivisceral resection for surgical T4b colorectal cancer from January 2010 to December 2021. 3. All of the operations were performed with either open or laparoscopic surgery.
Who may be able to join
- The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation.
- All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation.
- All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation.
Who cannot join
- Patients with distant metastasis or recurrent colorectal cancer were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
This study attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.
Read the detailed description
Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer.
This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.
- Conditions
- Colorectal Cancer
- Being tested
- Laparoscopic surgery
- Keywords
- Colorectal cancer, Multivisceral resection, Laparoscope
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic surgeryProcedure or surgery
The laparoscopic approach was used for the treatment of clinical T4b colorectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic multivisceral resection group | Patients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer Receives: Procedure: Laparoscopic surgery | |
| Open multivisceral resection group | Patients who underwent open multivisceral resection for clinical T4b colorectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Measured: Until the end of the operation, an average of 8 hours.
Complications
Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Measured: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Hospital stay after surgery
Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days.
Measured: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Secondary outcomes (2)
Overall survival
Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.
Measured: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Disease-free survival
Disease-free survival is defined as the time from the surgery to disease recurrence or last follow-up, which was measured in months.
Measured: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Jan 2023
- Primary completion5 Jan 2023
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707598
- Sponsor's protocol ID
- NCC-2023
- Acronym
- C-PelvEx-01
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Sun J, Liu J, Mei S, Quan J, Hu G, Li B, Zhuang M, Wang X, Tang J. Comparison of short- and long-term outcomes between laparoscopic and open multivisceral resection for clinical T4b colorectal cancer: A multicentre retrospective cohort study in China. Eur J Surg Oncol. 2024 Jan;50(1):107316. doi: 10.1016/j.ejso.2023.107316. Epub 2023 Dec 7.
PubMed 38086316
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivisceral Radical Resection for Surgical T4b Colorectal Cancer: Propensity Score-matched Study Comparing the the Laparoscopic and Open Approaches
- ClinicalTrials.gov ID
- NCT05707598
- Acronym / sponsor ID
- C-PelvEx-01 / NCC-2023
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Multivisceral resection, Laparoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 1 Feb 2023 (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 attempts to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b Colorectal cancer.
Detailed description
Laparoscopic surgery is controversial for patients with T4b colorectal cancer who require multivisceral resection. With the expansion of the indications for laparoscopic surgery in recent years, surgeons try to perform laparoscopic multivisceral resection for the treatment of clinical T4b colorectal cancer. In this study, investigators attempted to compare safety and long-term oncological outcomes between laparoscopic surgery and open surgery in the treatment of clinical T4b colorectal cancer.
This study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization. According to the operation method, the patients were divided into laparoscopic multivisceral resection group(patients who underwent laparoscopic surgery or conversion to open surgery) and open multivisceral resection group(patients who underwent open surgery directly). The short-term and long-term result was compared between groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic multivisceral resection group | – | Procedure: Laparoscopic surgeryPatients who underwent laparoscopic multivisceral resection for clinical T4b colorectal cancer |
| Open multivisceral resection group | – | –Patients who underwent open multivisceral resection for clinical T4b colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. The patients were diagnosed with colorectal cancer and the tumor was considered to have invaded the adjacent organs before surgery. 2. The patient experienced multivisceral resection for surgical T4b colorectal cancer from January 2010 to December 2021. 3. All of the operations were performed with either open or laparoscopic surgery.
Key inclusion criteria (3 listed)
- The patient was pathologically diagnosed as colorectal adenocarcinoma by endoscopic biopsy before operation.
- All patients were considered to have tumors invading adjacent organs after preoperative radiographic evaluation.
- All patients were recommended to undergo radical surgery after preoperative multidisciplinary consultation.
Key exclusion criteria (1 listed)
- Patients with distant metastasis or recurrent colorectal cancer were excluded.
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 |
|---|---|---|
| Laparoscopic surgeryThe laparoscopic approach was used for the treatment of clinical T4b colorectal cancer | Procedure or surgery | Laparoscopic multivisceral resection group |
Primary outcome
Blood loss
Time frame: Until the end of the operation, an average of 8 hours.
Blood loss is defined as intraoperative blood loss and measured in milliliters(ml).
Complications
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Complications are defined as all surgery-related adverse events postoperatively, such as anastomotic leak, infection, which are measured in frequency.
Hospital stay after surgery
Time frame: Until the patient recovered and was discharged from the hospital, an average of 10 days.
Hospital stay after surgery is defined as the length of time from the end of surgery to the discharge of patient, which is measured in days.
2 secondary outcomes
Overall survival
Time frame: The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.
Disease-free survival
Time frame: The endpoint of the disease-free survival assessment is the last follow-up or disease recurrence. Follow-up time is up to 72 months.
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 27 Dec 2024.
- Derived from this study: PubMed 38086316Zhang J, Sun J, Liu J, Mei S, Quan J, Hu G, Li B, Zhuang M, Wang X, Tang J. Comparison of short- and long-term outcomes between laparoscopic and open multivisceral resection for clinical T4b colorectal cancer: A multicentre retrospective cohort study in China. Eur J Surg Oncol. 2024 Jan;50(1):107316. doi: 10.1016/j.ejso.2023.107316. Epub 2023 Dec 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 1 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 27 Dec 2024. 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?
Blood loss (time frame: Until the end of the operation, an average of 8 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707598, which also lists 1 linked publication.
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 27 Dec 2024.