Operation FindingLCMENCT01628250
Laparoscopic Complete Mesocolic Excision on Colon Cancer
A study testing laparoscopic complete mesocolic excision and D3-laparoscopic colectomy in people with Operation Finding and Complications, run by Bo Feng at 1 site in China.
Trial summary
Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Operation Finding, Complications, Pathology
- What is being tested?
- laparoscopic complete mesocolic excision and D3-laparoscopic colectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed colon cancer
- Signed consent
Who cannot join
- History of malignancy
- Intestinal obstruction or perforation
- Evidence of metastasis by preoperative examinations
- Deformity of spine
- Emergency case
- BMI > 29
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study
Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.
- Being tested
- laparoscopic complete mesocolic excision, D3-laparoscopic colectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic complete mesocolic excisionProcedure or surgery
Also called laparoscopic CME, Complete Medial Approach (CMA), Hybrid Medial Approach (HMA)
laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.
D3-laparoscopic colectomyProcedure or surgery
Also called D3 laparoscopic colectomy
D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic complete mesocolic excision | Active comparator | Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision Receives: Procedure: laparoscopic complete mesocolic excision |
| D3 laparoscopic colectomy | Active comparator | Randomized group of patients receiving laparoscopic colectomy with D3-resection Receives: Procedure: D3-laparoscopic colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological Outcomes Obtained Through the Surgeries
number of lymph nodes retrieved
Measured: 14 days after the surgery
Secondary outcomes (1)
Survival Rate
The follow up to the patients after the surgery to evaluate the oncological results of the technique
Measured: 3 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Operation FindingStudies of the same condition, open and under way.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Feng, Ruijin Hospital
- Investigators
- Bo Feng, MD/PhD, Principal investigator, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628250
- Sponsor's protocol ID
- SH-MIS
- Acronym
- LCME
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2012
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01628250
- Acronym / sponsor ID
- LCME / SH-MIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bo FengUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Posted 29 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic complete mesocolic excision | Active comparator | Procedure: laparoscopic complete mesocolic excisionRandomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision |
| D3 laparoscopic colectomy | Active comparator | Procedure: D3-laparoscopic colectomyRandomized group of patients receiving laparoscopic colectomy with D3-resection |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with pathologically confirmed colon cancer
- Signed consent
Key exclusion criteria (6 listed)
- History of malignancy
- Intestinal obstruction or perforation
- Evidence of metastasis by preoperative examinations
- Deformity of spine
- Emergency case
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 |
|---|---|---|
| laparoscopic complete mesocolic excisionAlso: laparoscopic CME, Complete Medial Approach (CMA), Hybrid Medial Approach (HMA)laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized. | Procedure or surgery | laparoscopic complete mesocolic excision |
| D3-laparoscopic colectomyAlso: D3 laparoscopic colectomyD3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. | Procedure or surgery | D3 laparoscopic colectomy |
Primary outcome
Histopathological Outcomes Obtained Through the Surgeries
Time frame: 14 days after the surgery
number of lymph nodes retrieved
1 secondary outcome
Survival Rate
Time frame: 3 years after the surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bo Feng, MD/PhD principal investigator
Shanghai Minimally Invasive Surgery Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic complete mesocolic excision and D3-laparoscopic colectomy in people with Operation Finding and Complications, run by Bo Feng 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 2 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: finished, as of the sponsor's last update on 15 Nov 2022. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Histopathological Outcomes Obtained Through the Surgeries (time frame: 14 days after the surgery). 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 15 Nov 2022.