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A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Peritonization | Experimental |
| |
| Without Pelvic Peritonization | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure of the pelvic peritoneum | Procedure | Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade III-IV complications | The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reoperation | The rate of reoperation after leakage | 30 days |
| Detection of inflammation markers | C-reactive protein(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) |
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Inclusion Criteria:
Exclusion Criteria:
Elimination criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tang Bo, MD | Contact | +8613883902288 | tangtbo@sina.cn | |
| Li Chuan | Contact | +86-18323479228 | lee_tran@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery Center of PLA | Recruiting | Chongqing | 400038 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Nonclosure of the pelvic peritoneum | Procedure | Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner. |
|
| 7 days |
| The rate of anastomotic leakage | Clinical diagnostic criteria for anastomotic leakage: 1. Abdominal and systemic infection symptoms: abdominal pain, bloating, fever, elevated white blood cells, PCT, CRP and other inflammation indicators; 2. Gas, pus, feces passing through the pelvic drainage tube, abdominal incision, etc. | 30 days |
| Hospital time | Comparison of hospital stay between the two groups | 30 days |
| Overall complication rate | Overall complication rate include I-IV grade | 30days |
| Estimated blood loss | Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation | 1 day |
| Operation time | The time from start to end of surgery | 1 day |
| Postoperative bleeding | Postoperative intra-abdominal bleeding | 7 days |
| Intestinal obstruction | Incidence of intestinal obstruction caused by various reasons after surgery | 30 days |
| Readmission rate | Rate of hospital readmissions due to complications after discharge | 30 days |
| LARS | Low Anterior resection syndrome caused by rectal surgery | 12 months |
| Acute inflammatory Response | Procalcitonin(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) | 7 days |
| Acute inflammatory Response | Check Neutrophils(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) | 7 days |
| Detection of other inflammation markers | interleukin-6(1, 3, 5, 7 days after operation, and 1 day before discharge, all blood drawn is venous blood) | 7 days |
| Treatment cost | Comparison of cost between the two groups | 30 days |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |