Colorectal CancermSILSCNCT03633539
Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
A study testing Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer and Colonic Neoplasms, 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 single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms
- What is being tested?
- Single-incision 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- Aug 2020to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years < age ≤85 years
- 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 8th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less
- ECOG score is 0-1
- ASA score is Ⅰ-Ⅲ
- Informed consent
Who cannot join
- Body mass index (BMI) >35 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery（except appendectomy and cholecystotomy）
- 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.
About this study
Official title: Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
This study is designed to evaluate the short-term and long-term results after single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Read the detailed description
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
- Conditions
- Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms, Colon Disease, Colon Cancer, Rectal Cancer
- Being tested
- Single-incision Laparoscopic Surgery, Conventional Laparoscopic Surgery
- Keywords
- SILS, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Colonic Diseases, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-incision Laparoscopic SurgeryProcedure or surgery
Also called SILSC
Patients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
Conventional Laparoscopic SurgeryProcedure or surgery
Also called CLSC
Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Laparoscopic Surgery | Active comparator | Patients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）. Receives: Procedure: Conventional Laparoscopic Surgery |
| Single-incision Laparoscopic Surgery | Experimental | Patients with colorectal cancer undergo single-incision laparoscopic surgery. Receives: Procedure: Single-incision Laparoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications rate 30 days after surgery
Measured: 30 days after surgery
Secondary outcomes (11)
Operative time
Operative time（minutes）
Measured: intraoperative
Intraoperative blood loss
Estimated blood loss（milliliters，ml）
Measured: intraoperative
Incision length
Incision length（centimeters，cm）
Measured: intraoperative
Lymph node detection
Lymph nodes harvested（numbers）
Measured: 14 days after surgery
Incisal margin
Length of proximal and distal margin （centimeters，cm）
Measured: 14 days after surgery
Tumor size
The diameter of tumors（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 posted16 Aug 2018
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: No research funds were raised
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 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Fudan University, RenJi Hospital
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
- Investigators
- Kun Liu, MD, Study chair, Ruijin Hospitla North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633539
- Sponsor's protocol ID
- RJ-mSILSC-2018
- Acronym
- mSILSC
- Status last verified
- Sep 2021
- First submitted
- 14 Aug 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.
PubMed 30043168
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Prospective Randomized Controlled Study of the Single-incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03633539
- Acronym / sponsor ID
- mSILSC / RJ-mSILSC-2018
- Conditions
- Colorectal Cancer, Colonic Neoplasms, Rectal Neoplasms, Colon Disease, Colon Cancer, Rectal Cancer
- Keywords
- SILS, colorectal cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No research funds were raised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Fudan University, RenJi Hospital
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Aug 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 single incision laparoscopic surgery for colorectal cancer（SILSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.
Detailed description
In order to improve cosmetic effect and reduce postoperative pain, single-incision laparoscopic surgery (SILS) is attracting increasing attention. SILS is considered to be the next major advance in the progress of minimally invasive surgical approaches to colorectal disease that is more feasible in generalized use. In most previous studies, SILS for colorectal cancer was feasible and short-term safe compared to conventional laparoscopic surgery (CLS) . However, there is still controversy over its potential better cosmetic effect and less postoperative pain. Moreover, the long-term oncologic outcomes are still inconclusive as only a few studies showed long-term survival data. Up to now, most studies were limited to their retrospective nature and small samples. So more studies, especially large-scale, randomized controlled trials are needed to establish the best indications for SILS for colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Laparoscopic Surgery | Active comparator | Procedure: Conventional Laparoscopic SurgeryPatients with colorectal cancer undergo conventional laparoscopic surgery（multi-ports）. |
| Single-incision Laparoscopic Surgery | Experimental | Procedure: Single-incision Laparoscopic SurgeryPatients with colorectal cancer undergo single-incision laparoscopic surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years < age ≤85 years
- 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 8th Edition of AJCC Cancer Staging Manual
- Tumor size of 5 cm or less
Key exclusion criteria (7 listed)
- Body mass index (BMI) >35 kg/m2
- The lower border of the tumor is located distal to the peritoneal reflection
- Pregnant woman or lactating woman
- Severe mental disease
- Previous abdominal surgery（except appendectomy and cholecystotomy）
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 |
|---|---|---|
| Single-incision Laparoscopic SurgeryAlso: SILSCPatients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery. | Procedure or surgery | Single-incision Laparoscopic Surgery |
| Conventional Laparoscopic SurgeryAlso: CLSCPatients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions. | Procedure or surgery | Conventional Laparoscopic Surgery |
Primary outcome
Postoperative complications
Time frame: 30 days after surgery
Postoperative complications rate 30 days after surgery
11 secondary outcomes
Operative time
Time frame: intraoperative
Intraoperative blood loss
Time frame: intraoperative
Incision length
Time frame: intraoperative
Lymph node detection
Time frame: 14 days after surgery
Incisal margin
Time frame: 14 days after surgery
Tumor size
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Results publication: PubMed 30043168Song Z, Li Y, Liu K, Jiang Y, Shi Y, Ji X, Zhang T, Wu H, Shi Y, Zhao R. Clinical and oncologic outcomes of single-incision laparoscopic surgery for right colon cancer: a propensity score matching analysis. Surg Endosc. 2019 Apr;33(4):1117-1123. doi: 10.1007/s00464-018-6370-2. Epub 2018 Jul 24.
- Individual participant dataSharing planned: Undecided
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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.
Kun Liu, MD study chair
Ruijin Hospitla North
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-incision Laparoscopic Surgery and Conventional Laparoscopic Surgery in people with Colorectal Cancer and Colonic Neoplasms, 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 8 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Sep 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Postoperative complications (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 NCT03633539, 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 10 Sep 2021.