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The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium & low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.
Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).
We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR | Active Comparator |
| |
| Non-PR | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor Reconstruction | Procedure | Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer | 30 days after surgery | |
| Re-operation rate after anastomotic leakage | 30 days after surgery | |
| The rate of general complications | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operation day | |
| Postoperative hospital stay | 1 year after surgery | |
| Incidence of defecation dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tang Bo, MD | Contact | +862368754167 | tangtbo@sina.com | |
| Li Chuan, MD | Contact | +862368754167 | 79168391@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery Center of PLA | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
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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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| From the date of operation until the date of complication,assessed up to 3 years |
| 3-year local recurrence rate | From date of operation until the date of local-recurrence (up to 3 years) |
| 5-year disease-free survival | From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire | 1 year after operation |
| Blood loss | Operation day |
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample | 1 days after surgery |
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample | 3 days after surgery |
| White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample | 5 days after surgery |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |