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A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied.
To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy.
In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a high ligation of IMA | Experimental | total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery |
|
| a low ligation of IMA | Active Comparator | total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a high ligation of IMA | Procedure | total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis leakage rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomosis bleeding rate | 30 days | |
| disease-free survival | 5 years | |
| local recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueming Sun, PhD | Contact | 02568306026 | jssym@vip.sina.com | |
| Fumin Zhang, Professor | Contact | 02568306026 |
| Name | Affiliation | Role |
|---|---|---|
| Yueming Sun, PhD | The First Affiliated Hospital with Nanjing Medical University | Study Director |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| a low ligation of IMA | Procedure | total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery |
|
| 5 years |
| operative time | 1 day |
| number of lymph nodes retrieved | 1 day |
| postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire | Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQC30 questionnaire | 5 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |