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he purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic radical sigmoidectomy for sigmoid adenocarcinoma (cT2-T4a N0 M0,T1-T4a N+ M0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radical sigmoidectomy | No Intervention | radical sigmoidectomy | |
| radical sigmoidectomy combined with indocyanine green fluorescence imaging | Experimental | At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indocyanine green fluorescence imaging lymphatic tracing | Procedure | At the end of routine operation, indocyanine green was used for lymph node tracing, and further lymph node dissection was performed according to the tracer results. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival rate | odisease-free survival was defined as the time from surgery to the time of recurrence or death from any cause | 3 years after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of retrieved lymph nodes | Compare total number of retrieved lymph nodes in both group | 14 days after the surgery |
| Number of Metastasis Lymph Nodes | Compare number of positive lymph nodes in both group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen University, Sixth Affiliated Hospital | Guangzhou | Guangdong | 510655 | China |
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| 14 days after the surgery |
| The number of lymph nodes at each station | 14 days after the surgery |
| The rate of fluorescence | The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group | 14 days after the surgery |
| Positive rate | The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group | 14 days after the surgery |
| False positive rate | The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group | 14 days after the surgery |
| Negative rate | The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group | 14 days after the surgery |
| False negative rate | The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group | 14 days after the surgery |
| Morbidity rate | This is for the early postoperative complication | 30 days after the surgery |
| mortality rate | mortality, which defined as the event observed within 30 days after surgery | 30 days after the surgery |
| Pathological outcomes checklist | Quality of the mesorectum specimen, number of harvested lymph nodes, status of circumferential resection margin, and distal resection margin | 14 days after the surgery |
| 3-year Overall survival rate | Overall survival was defined as the time from surgery to death from any cause | 3 years after the surgery |
| 5-year Overall survival rate | Overall survival was defined as the time from surgery to death from any cause | 5 years after the surgery |
| 5-year Disease-free survival rate | 5 years after the surgery |
| Local recurrence rate | Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis. | 3 years after the surgery |
| Postoperative function (voiding function, sexual function) and quality of life | 3 years after the surgery |
| The correlation between the number of lymph nodes and 3-year overall survival rate and 3-year disease-free survival rate | 3 years after the surgery |
| Minimal Residual Disease, MRD | 3 years after the surgery |
| ID | Term |
|---|---|
| D012811 | Sigmoid Neoplasms |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012810 | Sigmoid Diseases |
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