Colorectal CancerSELECTEDNCT05911152
Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
An observational study of Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intracorporeal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 1 Jan 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis
Who may be able to join
- Patients voluntarily enrolled in this study and signed an informed consent form;
- Age: 18-75 years;
- Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;
- Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;
- Preoperative staging as cT1-3NanyM0;
- Underwent laparoscopic surgery.
Who cannot join
- Contraindications to laparoscopic surgery;
- Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;
- Patients with distant metastasis;
- Patients with multiple primary colorectal cancers;
- Patients with a history of malignancy;
- Patients unwilling to sign the informed consent or unwilling to follow the study protocol for follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianqiang Tang, Dr., +8613661090026, doc_tjq@hotmail.com
Jianqiang Tang, Dr.
About this study
The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?
Read the detailed description
This study is a retrospective real-world research initiated by the Chinese Academy of Medical Sciences Cancer Hospital, including Cancer Hospital of the Chinese Academy of Medical Sciences, Shenzhen Hospital and Peking University First Hospital. The study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of cT1-4aNanyM0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from April 2016 to April 2020. The patients will be divided into the intracorporeal anastomosis group (IA) and extracorporeal anastomosis group (EA) based on the surgical records. The primary endpoints of the study are 3-year disease-free survival (DFS) and 3-year overall survival (OS). The secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.
- Conditions
- Colorectal Cancer
- Being tested
- Intracorporeal anastomosis
- Keywords
- Colorectal cancer, Minimally invasive surgery, Laparoscopic surgery, Intracorporeal anastomosis
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracorporeal anastomosisProcedure or surgery
Surgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection
| Study group | Role | What they receive |
|---|---|---|
| Intracorporeal anastomosis | Patients underwent laparoscopic colorectal surgery with intracorporeal anastomosis Receives: Procedure: Intracorporeal anastomosis | |
| Extracorporeal anastomosis | Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery
Measured: 3 year
3-year overall survival
Percentage of patients who are still alive at the end of a 3-year period after surgery
Measured: 3 year
Secondary outcomes (5)
Rate of postoperative complications
Rate of postoperative complications within 30 days after surgery
Measured: 30 days
Time to first flatus after surgery
Time to first flatus after surgery
Measured: 7 days
Time to first stool after surgery
Time to first stool after surgery
Measured: 7 days
Length of stay after surgery
Length of stay after surgery
Measured: 30 days
Postoperative pain score
VAS (Visual Analog Scale) score is used to assess the postoperative pain level in patients. It is a measurement tool used to assess the intensity or severity of a subjective experience, typically related to pain or discomfort. The VAS score involves a straight line or a numerical scale ranging from 0 to 10, where 0 represents no pain or discomfort and 10 represents the worst possible pain or discomfort. Individuals are asked to indicate their level of pain or discomfort by marking a point on the scale, and the score is determined by measuring the distance from the 0 mark to the marked point. The VAS score provides a subjective assessment of pain or discomfort experienced by an individual.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start1 Jan 2016
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Peking University First Hospital
- Responsible party
- Principal investigator, Jianqiang Tang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911152
- Sponsor's protocol ID
- NCC4050
- Acronym
- SELECTED
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang M, Dong S, Wang L, Liu Z, Zhou H, Liu Q, Chen Y, Tang J, Wang X. Short-term and long-term outcomes of intracorporeal anastomosis in laparoscopic segmental left colectomy for splenic flexure cancer - a multicenter retrospective cohort study of 342 cases. Int J Surg. 2024 Mar 1;110(3):1595-1604. doi: 10.1097/JS9.0000000000000974.
PubMed 38085798
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Laparoscopic Intracorporeal Anastomosis for Colorectal Surgery- A Multiple Center Real World Study
- ClinicalTrials.gov ID
- NCT05911152
- Acronym / sponsor ID
- SELECTED / NCC4050
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Minimally invasive surgery, Laparoscopic surgery, Intracorporeal anastomosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Peking University First Hospital
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Jun 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.
The goal of this observational study is to explore the safety and feasibility of laparoscopic intracorporeal anastomosis in colorectal cancer surgery. The main questions it aims to answer are: 1. If intracorporeal anastomosis is safe in terms of short-term outcome? 2. If intracorporeal anastomosis can achieve the same oncological outcome as conventional extracorporeal anastomosis?
Detailed description
This study is a retrospective real-world research initiated by the Chinese Academy of Medical Sciences Cancer Hospital, including Cancer Hospital of the Chinese Academy of Medical Sciences, Shenzhen Hospital and Peking University First Hospital. The study aims to retrospectively analyze the clinical data of approximately 2,000 patients who underwent laparoscopic surgery with preoperative imaging staging of cT1-4aNanyM0 and pathological diagnosis of adenocarcinoma or high-grade intraepithelial neoplasia from April 2016 to April 2020. The patients will be divided into the intracorporeal anastomosis group (IA) and extracorporeal anastomosis group (EA) based on the surgical records. The primary endpoints of the study are 3-year disease-free survival (DFS) and 3-year overall survival (OS). The secondary endpoints include overall complication rate within 30 days, postoperative pain score, time to first flatus after surgery, time to first bowel movement after surgery, time to first oral intake after surgery, length of hospital stay, and postoperative quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracorporeal anastomosis | – | Procedure: Intracorporeal anastomosisPatients underwent laparoscopic colorectal surgery with intracorporeal anastomosis |
| Extracorporeal anastomosis | – | –Patients underwent laparoscopic colorectal surgery with extracorporeal anastomosis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent laparoscopic colorectal surgery with intracorporeal or extracorporeal anastomosis
Key inclusion criteria (6 listed)
- Patients voluntarily enrolled in this study and signed an informed consent form;
- Age: 18-75 years;
- Completion of colonoscopy and biopsy, with pathological confirmation of adenocarcinoma or high-grade intraepithelial neoplasia;
- Preoperative enhanced CT or MRI examination showing no evidence of distant metastasis;
- Preoperative staging as cT1-3NanyM0;
Key exclusion criteria (6 listed)
- Contraindications to laparoscopic surgery;
- Cases requiring emergency surgery due to acute bowel obstruction, perforation, or bleeding;
- Patients with distant metastasis;
- Patients with multiple primary colorectal cancers;
- Patients with a history of malignancy;
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 anastomosisSurgeons perform totally laparoscopic intracorporeal digestive reconstruction after specimen resection | Procedure or surgery | Intracorporeal anastomosis |
Primary outcome
3-year disease free survival
Time frame: 3 year
Proportion of patients who remain alive without any signs or symptoms of disease recurrence or progression for a period of 3 years after surgery
3-year overall survival
Time frame: 3 year
Percentage of patients who are still alive at the end of a 3-year period after surgery
5 secondary outcomes
Rate of postoperative complications
Time frame: 30 days
Time to first flatus after surgery
Time frame: 7 days
Time to first stool after surgery
Time frame: 7 days
Length of stay after surgery
Time frame: 30 days
Postoperative pain score
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 38085798Zhang M, Dong S, Wang L, Liu Z, Zhou H, Liu Q, Chen Y, Tang J, Wang X. Short-term and long-term outcomes of intracorporeal anastomosis in laparoscopic segmental left colectomy for splenic flexure cancer - a multicenter retrospective cohort study of 342 cases. Int J Surg. 2024 Mar 1;110(3):1595-1604. doi: 10.1097/JS9.0000000000000974.
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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 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 6 inclusion and 6 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 27 Jun 2023. 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 Mingguang Zhang, Dr. (+8613261967603, zmgslimshady@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival (time frame: 3 year). The study lists 2 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 NCT05911152, 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 Jun 2023.