Colorectal CancerNCT03426514
Three-port Versus Conventional Laparoscopic Surgery for Colorectal Cancer
A study testing Three-port Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Three-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
- 282 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2018to Mar 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) <30 kg/m2
- Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
- Pathological colorectal carcinoma
- Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Who cannot join
- Previous gastrointestinal surgery
- History of inflammatory bowel disease
- History of familial adenomatous polyposis（FAP）
- Pregnant woman or lactating woman
- Severe mental disease
- Intolerance of surgery for severe comorbidities
- Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
- Requirement of simultaneous surgery for other disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Tao Zhang, MD, +86-13918805942, woodyhom@yahoo.com
About this study
Official title: Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Read the detailed description
At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.
- Conditions
- Colorectal Cancer
- Being tested
- Three-port Laparoscopic Surgery, Conventional Laparoscopic Surgery
- Keywords
- Colorectal cancer, Laparoscopic surgery, Three-port
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-port Laparoscopic SurgeryProcedure or surgery
Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.
Conventional Laparoscopic SurgeryProcedure or surgery
Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.
| Study group | Role | What they receive |
|---|---|---|
| Three-port Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo three-port laparoscopic surgery. Receives: Procedure: Three-port Laparoscopic Surgery |
| Conventional Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）. Receives: Procedure: Conventional Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early morbidity rate
morbidity rate 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (10)
Operative time
Operative time（minutes）
Measured: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: intraoperative
Lymph node detection
Lymph nodes harvested（numbers）
Measured: 14 days after surgery
Proximal resection margin
Length of proximal margin （centimeters，cm）
Measured: 14 days after surgery
Distal resection margin
Length of distal margin （centimeters，cm）
Measured: 14 days after surgery
Length of stay
Duration of hospital stay（days after surgery）
Measured: 1-14 days after surgery
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery）
Measured: 1-14 days after surgery
Pain score
Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge
Measured: 1-3 days after surgery
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months after surgery
5-year overall survival rate
5-year overall survival rate
Measured: 60 months 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 Feb 2018
- Study start25 Mar 2018
- Primary completionMar 2020 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Ruijin HospitalThe 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
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Tao Zhang, MD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426514
- Sponsor's protocol ID
- RJ-TLSC-2018
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tawfik Amin A, Elsaba TM, Amira G. Three ports laparoscopic resection for colorectal cancer: a step on refining of reduced port surgery. ISRN Surg. 2014 Mar 12;2014:781549. doi: 10.1155/2014/781549. eCollection 2014.
PubMed 25006515Seow-En I, Tan KY, Mohd Daud MA, Seow-Choen F. Traditional laparoscopic colorectal resections can be performed effectively using a three-port technique. Tech Coloproctol. 2011 Mar;15(1):91-3. doi: 10.1007/s10151-010-0660-6. Epub 2011 Jan 14. No abstract available.
PubMed 21234638
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Randomized Controlled Study of the Three-port Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03426514
- Acronym / sponsor ID
- RJ-TLSC-2018
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Laparoscopic surgery, Three-port
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Feb 2018 (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 is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Detailed description
At present，surgical treatments is the main means to cure colorectal cancer（CRC）.The use of four or more ports has been routine in most laparoscopic colorectal resections. However，the drawbacks are the need for added manpower, consisting of another assistant to provide counter-traction, as well as costs and the unaesthetic effects of additional ports. In order to minimize surgical trauma, improve cosmesis ,reduce manpower，single-incision laparoscopic surgery (SILS) is attracting increasing attention. But it is challenging and highly demanding techniques. Becoming proficient at three-port laparoscopic surgery can make the transition to SILS more nature.Few studies about three-port laparoscopic surgery for colorectal cancer（TLSC） have been reported currently.More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TLSC. This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 282 eligible patients will be randomly assigned to TLSC group and CLSC group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the the feasibility, safety, and potential benefits of TLSC compared with CLSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-port Laparoscopic Surgery | Experimental | Procedure: Three-port Laparoscopic SurgeryPatients with colorectal cancer undergo three-port laparoscopic surgery. |
| Conventional Laparoscopic Surgery | Experimental | Procedure: Conventional Laparoscopic SurgeryPatients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) <30 kg/m2
- Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
- Pathological colorectal carcinoma
- Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
- ECOG score is 0-1
Key exclusion criteria (8 listed)
- Previous gastrointestinal surgery
- History of inflammatory bowel disease
- History of familial adenomatous polyposis（FAP）
- Pregnant woman or lactating woman
- Severe mental disease
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 |
|---|---|---|
| Three-port Laparoscopic SurgeryPatients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery. | Procedure or surgery | Three-port Laparoscopic Surgery |
| Conventional Laparoscopic SurgeryPatients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction. | Procedure or surgery | Conventional Laparoscopic Surgery |
Primary outcome
Early morbidity rate
Time frame: 30 days after surgery
morbidity rate 30 days after surgery
10 secondary outcomes
Operative time
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
Lymph node detection
Time frame: 14 days after surgery
Proximal resection margin
Time frame: 14 days after surgery
Distal resection margin
Time frame: 14 days after surgery
Length of stay
Time frame: 1-14 days after surgery
Postoperative recovery course
Time frame: 1-14 days after surgery
Pain score
Time frame: 1-3 days after surgery
3-year disease free survival rate
Time frame: 36 months after surgery
5-year overall survival rate
Time frame: 60 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 25006515Tawfik Amin A, Elsaba TM, Amira G. Three ports laparoscopic resection for colorectal cancer: a step on refining of reduced port surgery. ISRN Surg. 2014 Mar 12;2014:781549. doi: 10.1155/2014/781549. eCollection 2014.
- Background: PubMed 21234638Seow-En I, Tan KY, Mohd Daud MA, Seow-Choen F. Traditional laparoscopic colorectal resections can be performed effectively using a three-port technique. Tech Coloproctol. 2011 Mar;15(1):91-3. doi: 10.1007/s10151-010-0660-6. Epub 2011 Jan 14. No abstract available.
- 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.
Tao Zhang, MD study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-port Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer, run by Ruijin Hospital 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 8 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 13 Feb 2020. 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 Ren Zhao, MD (+86-18917762018, rjzhaoren@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early morbidity 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?
On the ClinicalTrials.gov record for NCT03426514, which also lists 2 linked publications.
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 13 Feb 2020.