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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic complete mesocolic excision | Active Comparator | Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision |
|
| D3 laparoscopic colectomy | Active Comparator | Randomized group of patients receiving laparoscopic colectomy with D3-resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic complete mesocolic excision | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological Outcomes Obtained Through the Surgeries | number of lymph nodes retrieved | 14 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | The follow up to the patients after the surgery to evaluate the oncological results of the technique | 3 years after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Feng, MD/PhD | Shanghai Minimally Invasive Surgery Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Complete Mesocolic Excision | Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision laparoscopic complete mesocolic excision: 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. |
| FG001 | D3 Laparoscopic Colectomy | Randomized group of patients receiving laparoscopic colectomy with D3-resection D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laparoscopic Complete Mesocolic Excision | Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision laparoscopic complete mesocolic excision: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Histopathological Outcomes Obtained Through the Surgeries | number of lymph nodes retrieved | Posted | Mean | Standard Deviation | nodes | 14 days after the surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laparoscopic Complete Mesocolic Excision | Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision laparoscopic complete mesocolic excision: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vessel-related complication | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bo Feng | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | 021-64458887 | fengbo2022@163.com |
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|
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| D3-laparoscopic colectomy | Procedure | D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. |
|
|
| BG001 | D3 Laparoscopic Colectomy | Randomized group of patients receiving laparoscopic colectomy with D3-resection D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Randomized group of patients receiving laparoscopic colectomy with D3-resection
D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
|
|
| Secondary | Survival Rate | The follow up to the patients after the surgery to evaluate the oncological results of the technique | Not Posted | 3 years after the surgery | Participants |
| 12 |
| 49 |
| 0 |
| 49 |
| EG001 | D3 Laparoscopic Colectomy | Randomized group of patients receiving laparoscopic colectomy with D3-resection D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. | 19 | 50 | 0 | 50 |
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