Colorectal NeoplasmNCT05953662
Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer
A study testing Reduced-port laparoscopic surgery and conventional laparoscopic surgery in people with Colorectal Neoplasm, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- Reduced-port laparoscopic surgery and conventional laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 18-80 years old;
- Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma);
- Eastern Cooperative Oncology Group (ECOG) is 0-1 points;
- Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis;
- No other multiple primary tumors;
- No organ dysfunction;
- The patient and his/her family are able to understand the study protocol and are willing to participate in the study and sign informed consent.
Who cannot join
- Age < 18, or > 80 years old;
- Combined with simultaneous or heterogeneous (within 5 years) malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery;
- Joint organ resection is required;
- ASA Class IV or V;
- Suffering from a serious mental illness;
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- Patients with severe emphysema, interstitial pneumonia or ischemic heart disease, etc. who cannot tolerate surgery;
- Continuous systemic steroid therapy within 1 months;
- Patients or families are unable to understand the conditions and objectives of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong
About this study
Official title: Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer --an Open Label, Multicenter, Prospective Phase Ⅱ Study
Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.
Read the detailed description
Colorectal cancer is the third most common malignant tumor. In 2020, there were nearly 1.9 million new cases worldwide, accounting for about 10% of all new malignant tumors, and the related death exceeded 900,000. In recent years, the incidence of colorectal cancer in our country has been rising rapidly year by year, with more than 400,000 new cases each year, leading China to the largest number of colorectal cancer cases in the world. For resectable non-metastatic colorectal cancer, radical surgical resection is the mainstay of treatments. Compared with the open surgery, the laparoscopic colorectal cancer resection has smaller wounds, faster postoperative recovery, and shorter hospital stay. The 10-year results of the COLOR trial showed similar DFS, OS, and recurrence rates between open and laparoscopic surgery for colon cancer. In another trial (COST study), 872 patients with colon cancer were randomly assigned to open surgery or laparoscopic-assisted colectomy for curative colon cancer. After a median follow-up of 7 years, the 5-year recurrence rates and the 5-year OS rates were similar.
Traditional laparoscopic colorectal cancer resection can be carried out smoothly by close cooperation between the surgeon and the assistant. However, inexperienced assistants are likely to cause parainjuries due to the opposite field of the view and the narrow operating space. In recent years, single-port laparoscopy gradually goes into service. However, it is easy to cause instrument conflicts, straight-line viewing angles, and lack of traction. Therefore, single-port surgery is extremely unergonomic and difficult for the surgeon. Reduced-port laparoscopic surgery has been selectively used in some colon cancer anticipants. Reduced-port laparoscopic surgery reduces or completely eliminates the assistant's operating ports, and the surgeon mainly relies on himself/herself to complete the exposure of the operative field. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery is completed by the left and right hands of the surgeon, which is easier to coordinate, avoiding the prolongation of the operation time or even concomitant injury caused by the poor cooperation of the inexperienced assistant and the surgeon. Reduced-port laparoscopy reduces some surgical incisions, and extreme minimally invasive may result in less pain and faster recovery. From an economic point of view, the reduced-port laparoscopy reduces some surgical consumables and human resouce, leading to reduced cost of surgery.
In order to further explore the application of reduced-port laparoscopic surgery in patients with resectable colorectal cancer, the center plans to carry out a clinical study of 'reduced-port laparoscopic surgery versus traditional laparoscopic surgery for resectable colorectal cancer', aiming to evaluate the complications associated with perioperative surgery, R0 resection rate, 3-year disease-free survival rate, and 3-year overall survival rate.
- Conditions
- Colorectal Neoplasm
- Being tested
- Reduced-port laparoscopic surgery, conventional laparoscopic surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced-port laparoscopic surgeryProcedure or surgery
compare different operational styles of colon and upper rectal cancer
conventional laparoscopic surgeryProcedure or surgery
conventional laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Reduced-port laparoscopic surgery | Experimental | locations of trocars: A 10mm trocar is placed in the supraumbilical or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar on the ipsilateral side of the patient according to the intraoperative situation, as the main operation port and the secondary operation port, and the positions of the trocars follow the principle that the lesion is located at the triangular apex of the two trocars. Receives: Procedure: Reduced-port laparoscopic surgery |
| conventional laparoscopic surgery | Active comparator | locations of trocars: A 10mm trocar is placed in the supraumbilicus or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar in a suitable position according to the intraoperative situation as the main operation port and the secondary operation port. The assistant places two 5mm trocars in the appropriate position as the assistant operation port. Receives: Procedure: conventional laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS rate
Disease-free survival rate
Measured: 1 year
Secondary outcomes (7)
Total opertaion time
Time from surgery started to surgery ended
Measured: through opertation completion, an average of 2 hours
Intraoperative blood loss
Blood loss during operation
Measured: through study completion, an average of 50 ml
Postoperative hospital stay
Day from operation finished to patient discharged
Measured: through anticipants discharged, an average of 7 days
Postoperative complication rate
Any complication associated with operation based on Clavien-Dindo classification
Measured: 30 days
Postoperative mortality
Death associated with operation
Measured: 30 days
3 years DFS Rate
Disease-free survival rate
Measured: 3 years
3 years OS Rate
Overall survival rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Sep 2023
- Primary completion1 Apr 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Huang, MD, Principal investigator, six affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953662
- Sponsor's protocol ID
- E2023044
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2023
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer --an Open Label, Multicenter, Prospective Phase Ⅱ Study
- ClinicalTrials.gov ID
- NCT05953662
- Acronym / sponsor ID
- E2023044
- Conditions
- Colorectal Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 Jul 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.
Colorectal cancer is the third most common malignant tumor. Radical resection is the mainstay of treatments for non-metastatic colorectal cancer. In case of traditional laparoscopic surgery, inexperienced assistants are likely to cause side injuries and interfere surgeon due to limited operating space. Reduced-port laparoscopic surgery has only 3 ports for surgeon and observer, and the surgeon completes the surgery independently, which increases the difficulty of the operation. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery avoids the prolongation of the operation time and parainjury caused by inexperienced assistant. Reduced-port laparoscopy reduces some surgical incisions, resulting in less pain and faster recovery. Reduced-port laparoscopy also reduces the consumables, human resources and medical expenses. This study aims to evaluate the curative effect and safety of reduced-port laparoscopic surgery versus conventional laparoscopic surgery for resectable colorectal cancer.
Detailed description
Colorectal cancer is the third most common malignant tumor. In 2020, there were nearly 1.9 million new cases worldwide, accounting for about 10% of all new malignant tumors, and the related death exceeded 900,000. In recent years, the incidence of colorectal cancer in our country has been rising rapidly year by year, with more than 400,000 new cases each year, leading China to the largest number of colorectal cancer cases in the world. For resectable non-metastatic colorectal cancer, radical surgical resection is the mainstay of treatments. Compared with the open surgery, the laparoscopic colorectal cancer resection has smaller wounds, faster postoperative recovery, and shorter hospital stay. The 10-year results of the COLOR trial showed similar DFS, OS, and recurrence rates between open and laparoscopic surgery for colon cancer. In another trial (COST study), 872 patients with colon cancer were randomly assigned to open surgery or laparoscopic-assisted colectomy for curative colon cancer. After a median follow-up of 7 years, the 5-year recurrence rates and the 5-year OS rates were similar.
Traditional laparoscopic colorectal cancer resection can be carried out smoothly by close cooperation between the surgeon and the assistant. However, inexperienced assistants are likely to cause parainjuries due to the opposite field of the view and the narrow operating space. In recent years, single-port laparoscopy gradually goes into service. However, it is easy to cause instrument conflicts, straight-line viewing angles, and lack of traction. Therefore, single-port surgery is extremely unergonomic and difficult for the surgeon. Reduced-port laparoscopic surgery has been selectively used in some colon cancer anticipants. Reduced-port laparoscopic surgery reduces or completely eliminates the assistant's operating ports, and the surgeon mainly relies on himself/herself to complete the exposure of the operative field. However, reduced-port laparoscopy has some potential advantages and applications. Reduced-port laparoscopic surgery is completed by the left and right hands of the surgeon, which is easier to coordinate, avoiding the prolongation of the operation time or even concomitant injury caused by the poor cooperation of the inexperienced assistant and the surgeon. Reduced-port laparoscopy reduces some surgical incisions, and extreme minimally invasive may result in less pain and faster recovery. From an economic point of view, the reduced-port laparoscopy reduces some surgical consumables and human resouce, leading to reduced cost of surgery.
In order to further explore the application of reduced-port laparoscopic surgery in patients with resectable colorectal cancer, the center plans to carry out a clinical study of 'reduced-port laparoscopic surgery versus traditional laparoscopic surgery for resectable colorectal cancer', aiming to evaluate the complications associated with perioperative surgery, R0 resection rate, 3-year disease-free survival rate, and 3-year overall survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced-port laparoscopic surgery | Experimental | Procedure: Reduced-port laparoscopic surgerylocations of trocars: A 10mm trocar is placed in the supraumbilical or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar on the ipsilateral side of the patient according to the intraoperative situation, as the main operation port and the secondary operation port, and the positions of the trocars follow the principle that the lesion is located at the triangular apex of the two trocars. |
| conventional laparoscopic surgery | Active comparator | Procedure: conventional laparoscopic surgerylocations of trocars: A 10mm trocar is placed in the supraumbilicus or subumbilicus as an observation port, and the surgeon inserts a 10mm trocar and a 5mm trocar in a suitable position according to the intraoperative situation as the main operation port and the secondary operation port. The assistant places two 5mm trocars in the appropriate position as the assistant operation port. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years old;
- Pathological diagnosis of colorectal adenocarcinoma (including high, medium and low-differentiated adenocarcinoma, excluded: mucinous adenocarcinoma, signet ring cell carcinoma);
- Eastern Cooperative Oncology Group (ECOG) is 0-1 points;
- Chest, whole abdomen, pelvic enhanced CT confirm colon or upper rectal cancer, without distant metastasis;
- No other multiple primary tumors;
Key exclusion criteria (9 listed)
- Age < 18, or > 80 years old;
- Combined with simultaneous or heterogeneous (within 5 years) malignant tumors;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who require emergency surgery;
- Joint organ resection is required;
- ASA Class IV or V;
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 |
|---|---|---|
| Reduced-port laparoscopic surgerycompare different operational styles of colon and upper rectal cancer | Procedure or surgery | Reduced-port laparoscopic surgery |
| conventional laparoscopic surgeryconventional laparoscopic surgery | Procedure or surgery | conventional laparoscopic surgery |
Primary outcome
DFS rate
Time frame: 1 year
Disease-free survival rate
7 secondary outcomes
Total opertaion time
Time frame: through opertation completion, an average of 2 hours
Intraoperative blood loss
Time frame: through study completion, an average of 50 ml
Postoperative hospital stay
Time frame: through anticipants discharged, an average of 7 days
Postoperative complication rate
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
3 years DFS Rate
Time frame: 3 years
3 years OS Rate
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Jun Huang, MD principal investigator
six affiliated hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced-port laparoscopic surgery and conventional laparoscopic surgery in people with Colorectal Neoplasm, run by Sixth Affiliated Hospital, Sun Yat-sen 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 7 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
DFS rate (time frame: 1 year). 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 27 Apr 2026.