Colorectal CancerSoMiniCRCNCT03843398
Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
A study testing Colorectal cancer resection via minilaparotomy and Laparoscopic colorectal cancer resection in people with Colorectal Cancer, run by Changhai Hospital.
Trial summary
The primary aim of this study is to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy.. Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colorectal cancer resection via minilaparotomy and Laparoscopic colorectal cancer resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal cancer with pathological results.
- Colorectal cancer preliminary diagnosed during colonoscopy.
- No confirmed metastasis.
- No comorbidity of other malignancy.
- The primary tumor is less than 10 cm.
- No organ dysfunction.
- The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.
Who cannot join
- Diagnosed with any other malignancy within 5 years.
- Comorbidity of emergent conditions like perforation.
- Former colorectal surgery history which may affects digestive tract reconstruction.
- Need combined organ resection.
- ASA grade IV or V.
- Pregnant or lactating Women.
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- Severe mental diseases.
- Severe cardiopulmonary diseases which reduce operation tolerance.
- Systematic steroid therapy lasting for more than 1 month.
- Intolerant of laparoscopy.
- No written informed consent form signed.
Trial locations and contacts
No sites are listed yet.
About this study
The primary aim of this study is
- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..
Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.
- 3-year disease free survival, 3y DFS
- 5-year overall survival, 5y OS
- 5-year disease free survival, 5y DFS
- Local recurrence rate, LRR
- Postoperative complications Incidence and mortality at 30 days
- Conditions
- Colorectal Cancer
- Being tested
- Colorectal cancer resection via minilaparotomy, Laparoscopic colorectal cancer resection
- Keywords
- Colorectal Cancer, Minilaparotomy, Survival
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal cancer resection via minilaparotomyProcedure or surgery
Also called Minilaparotomy
According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.
Laparoscopic colorectal cancer resectionProcedure or surgery
Also called Laparoscopy
This is one of the routine procedures used for colorectal cancer resection.
| Study group | Role | What they receive |
|---|---|---|
| Minilaparotomy Group | Experimental | Participants in this arm undergo colorectal cancer resection via minilaparotomy. Receives: Procedure: Colorectal cancer resection via minilaparotomy |
| Laparoscopy Group | Active comparator | Participants in this arm undergo laparoscopic colorectal cancer resection. Receives: Procedure: Laparoscopic colorectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival, 3y OS
3y OS
Measured: 3 years after the follow up of the last patient enrolled.
Secondary outcomes (6)
5-year overall survival, 5y OS
5y OS
Measured: 5 years after the follow up of the last patient enrolled.
3-year disease free survival, 3y DFS
3y DFS
Measured: 3 years after the follow up of the last patient enrolled.
5-year disease free survival, 3y DFS
5y DFS
Measured: 5 years after the follow up of the last patient enrolled.
Local recurrence rate, LRR
LRR
Measured: 3 years after the follow up of the last patient enrolled.
Postoperative complications Incidence at 30 days
PCI30
Measured: 30 days after the operation of the last patient enrolled.
Postoperative mortality at 30 days
PM30
Measured: 30 days after the operation of the last patient enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2026 (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 Changhai 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
- 992 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
- Investigators
- En-Da YU, MBBS, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843398
- Sponsor's protocol ID
- SINOCOLO2019C
- Acronym
- SoMiniCRC
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang XD, Huang MJ, Yang CH, Li K, Li L. Minilaparotomy to rectal cancer has higher overall survival rate and earlier short-term recovery. World J Gastroenterol. 2012 Oct 7;18(37):5289-94. doi: 10.3748/wjg.v18.i37.5289.
PubMed 23066325Ishida H, Ishiguro T, Ohsawa T, Okada N, Kumamoto K, Ishibashi K, Haga N, Yokoyama M, Nakada H, Gonda T. Oncologic outcome of stages II/III colon cancer treated via minilaparotomy. Int Surg. 2011 Apr-Jun;96(2):127-34. doi: 10.9738/1384.1.
PubMed 22026303
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03843398
- Acronym / sponsor ID
- SoMiniCRC / SINOCOLO2019C
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Minilaparotomy, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 992 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 Feb 2019 (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 primary aim of this study is
- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..
Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.
- 3-year disease free survival, 3y DFS
- 5-year overall survival, 5y OS
- 5-year disease free survival, 5y DFS
- Local recurrence rate, LRR
- Postoperative complications Incidence and mortality at 30 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minilaparotomy Group | Experimental | Procedure: Colorectal cancer resection via minilaparotomyParticipants in this arm undergo colorectal cancer resection via minilaparotomy. |
| Laparoscopy Group | Active comparator | Procedure: Laparoscopic colorectal cancer resectionParticipants in this arm undergo laparoscopic colorectal cancer resection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Colorectal cancer with pathological results.
- Colorectal cancer preliminary diagnosed during colonoscopy.
- No confirmed metastasis.
- No comorbidity of other malignancy.
- The primary tumor is less than 10 cm.
Key exclusion criteria (11 listed)
- Diagnosed with any other malignancy within 5 years.
- Comorbidity of emergent conditions like perforation.
- Former colorectal surgery history which may affects digestive tract reconstruction.
- Need combined organ resection.
- ASA grade 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 |
|---|---|---|
| Colorectal cancer resection via minilaparotomyAlso: MinilaparotomyAccording to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined. | Procedure or surgery | Minilaparotomy Group |
| Laparoscopic colorectal cancer resectionAlso: LaparoscopyThis is one of the routine procedures used for colorectal cancer resection. | Procedure or surgery | Laparoscopy Group |
Primary outcome
3-year overall survival, 3y OS
Time frame: 3 years after the follow up of the last patient enrolled.
3y OS
6 secondary outcomes
5-year overall survival, 5y OS
Time frame: 5 years after the follow up of the last patient enrolled.
3-year disease free survival, 3y DFS
Time frame: 3 years after the follow up of the last patient enrolled.
5-year disease free survival, 3y DFS
Time frame: 5 years after the follow up of the last patient enrolled.
Local recurrence rate, LRR
Time frame: 3 years after the follow up of the last patient enrolled.
Postoperative complications Incidence at 30 days
Time frame: 30 days after the operation of the last patient enrolled.
Postoperative mortality at 30 days
Time frame: 30 days after the operation of the last patient enrolled.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 23066325Wang XD, Huang MJ, Yang CH, Li K, Li L. Minilaparotomy to rectal cancer has higher overall survival rate and earlier short-term recovery. World J Gastroenterol. 2012 Oct 7;18(37):5289-94. doi: 10.3748/wjg.v18.i37.5289.
- Background: PubMed 22026303Ishida H, Ishiguro T, Ohsawa T, Okada N, Kumamoto K, Ishibashi K, Haga N, Yokoyama M, Nakada H, Gonda T. Oncologic outcome of stages II/III colon cancer treated via minilaparotomy. Int Surg. 2011 Apr-Jun;96(2):127-34. doi: 10.9738/1384.1.
- PubMed linkLink provided by the sponsor.
- PubMed linkLink provided by the sponsor.
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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.
En-Da YU, MBBS principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal cancer resection via minilaparotomy and Laparoscopic colorectal cancer resection in people with Colorectal Cancer, run by Changhai Hospital.
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 11 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Zi-Ye ZHAO, MD (8618699629177, yemenzhao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival, 3y OS (time frame: 3 years after the follow up of the last patient enrolled.). 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 NCT03843398, 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 18 Feb 2019.