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To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.
To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.
A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the caudal-to-cranial approach | Experimental | Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein（SMV）and Superior mesenteric artery（SMA）and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein（SMV）. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called caudal-to-cranial approach. |
|
| the medial-to-lateral approach | Active Comparator | First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein（SMV）to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the caudal-to-cranial approach | Procedure | Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach. |
| Measure | Description | Time Frame |
|---|---|---|
| the operation time | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| the total blood loss | up to 36 months | |
| the number of lymph nodes dissected | up to 36 months | |
| the average time of ground activities |
| Measure | Description | Time Frame |
|---|---|---|
| the 3-year and 5-year Disease-free survival（DFS） | up to 3 years and 5 years | |
| 3-year and 5-year Overall survival（OS） | up to 3 years and 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liao-nan Zou, MD. | Contact | 0086-020-13423663496 | 13423663496@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liao-nan Zou, professor | GI surgery,Guangdong Province Hospital of Chinese Medicine | Principal Investigator |
| Jin Wan, PhD | GI surgery,Guangdong Province Hospital of Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI surgery,Guangdong Province Hospital of Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26616807 | Result | Zou L, Xiong W, Li H, He Y, Diao D, Zheng Y, Luo L, Tan P, Wang W, Wan J. [Efficacy analysis of laparoscopic radical right hemicolectomy using caudal-to-cranial approach]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Nov;18(11):1124-7. Chinese. | |
| 27072997 | Result | Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12. |
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|
| the medial-to-lateral approach | Procedure | First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach |
|
| up to 36 months |
| the time to first flatus | up to 36 months |
| the intra-operative complication and the post-operative complication | up to 36 months |
| 27318491 | Result | Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18. |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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