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This study is designed to evaluate the short-term and long-term results after transanal total mesorectal excision (TaTME) for the resection of mid and low rectal cancer compared with laparoscopic total mesorectal excision（LaTME）.
Colorectal cancer (CRC) including rectal cancer is one of the most common gastrointestinal tumors, and its incidence is third in the world. At present，surgical treatments is the main means to cure CRC. Total mesorectal excision (TME) is the gold standard for rectal cancer surgery. Transanal total mesorectal excision (TaTME) was recently developed to overcome technical difficulties associated with LaTME and open TME. Most reports are retrospective studies. More studies, especially large-scale, randomized controlled trials are needed to establish the best indications for TaTME for mid and low rectal cancer.This is a single-center, open-label, non-inferiority, randomized controlled trial. A total of 120 eligible patients will be randomly assigned to TaTME group and LaTME group at a 1:1 ratio. It will provide valuable clinical evidence for the objective assessment of the oncological safety，efficacy and potential benefits of TaTME compared with LaTME for mid and low rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TaTME | Experimental | Patients with mid or low rectal cancer undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） |
|
| LaTME | Active Comparator | Patients with mid or low rectal cancer undergo laparoscopic total mesorectal excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal total mesorectal excision | Procedure | Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA） |
|
| Measure | Description | Time Frame |
|---|---|---|
| Circumferential resection margin (CRM) | Positive rate of circumferential resection margin (pathological assessment) | 14 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of mesorectum | Pathological assessment of completeness of the TME specimen（complete, near | 14 days after surgery |
| Lymph node detection | Lymph nodes harvested（numbers） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yimei Jiang, MD | Ruijin Hospitla North | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital North | Shanghai | Shanghai Municipality | 201821 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26466751 | Background | Simillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151. | |
| 25185463 | Background | Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865. |
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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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| Laparoscopic total mesorectal excision | Procedure | Patients undergo Laparoscopic total mesorectal excision. |
|
| 14 days after surgery |
| Distal safety margin | Length of distal margin （millimeter，mm） | 14 days after surgery |
| Operative time | Operative time（minutes） | Intraoperative |
| Intraoperative blood loss | Estimated blood loss（milliliters，ml） | Intraoperative |
| Length of stay | Duration of hospital stay（days after surgery） | 1-30 days after surgery |
| Postoperative recovery course | Time to first ambulation, flatus, liquid diet and soft diet （hours after surgery） | 1-14 days after surgery |
| Early morbidity rate | Morbidity rate 30 days after surgery | 30 days |
| Pain score | Postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3 and the day of discharge | 1-3 days after surgery |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months after surgery |
| 5-year overall survival rate | 5-year overall survival rate | 60 months after surgery |
| 26537907 | Background | Deijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |