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The purpose of this study is to compare the safety and efficacy of laparoscopic resection with natural orifice specimen extraction versus conventional laparoscopic surgery for sigmoid colon or rectal cancer.
Further study details as provided by Chinese Academy of Medical Sciences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transrectal specimen extraction | Experimental | Laparoscopic colorectal resection with natural orifice specimen extraction will be performed for patients in this group. |
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| Conventional laparoscopic surgery | Active Comparator | Conventional laparoscopic surgery for colorectal cancer will be performed for patients in this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transrectal specimen extraction | Procedure | After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Early morbidity rate | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the intervention | Duration of surgery. | 1 day |
| Peritoneal bacterial contamination | Peritoneal fluid samples were collected under sterile conditions at the end of the procedure and sent for gram stain as well as anaerobic, aerobic, and fungal cultures.We assess the contamination rate of peritoneal fluid in the two interventions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhixiang Zhou, M.D. | Contact | +86-139-1123-2981 | Dr_zhouzx@163.com | |
| Jianwei Liang, M.D. | Contact | +86-130-7119-7461 | liangjw1976@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhixiang Zhou, M.D. | Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Conventional laparoscopic surgery | Procedure | High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection. |
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| 1 day |
| Pain score | Recording of the needed analgesia guided by pain score | 14 days |
| 3-year disease free survival rate | A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test. | 3 years |
| 5-year overall survival rate | A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test. | 5 years |
| Plasma levels of several cytokines after colorectal cancer surgery | We have measured and compared perioperative plasma levels of interleukin-2, interleukin-6, interleukin-8, C-reactive protein and procalcitonin in the two group sample. | 7 days |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D012002 | Rectal Diseases |
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