Rectal Cancer Clinical Trial
Official title:
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer
NCT number | NCT04573738 |
Other study ID # | 20200913 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | September 30, 2021 |
Verified date | November 2023 |
Source | Third Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.
Status | Completed |
Enrollment | 13 |
Est. completion date | September 30, 2021 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Pathological biopsy confirmed adenocarcinoma of the rectum. 2. Preoperative assessment of tolerance to surgery without major organ dysfunction. 3. Patients must be able to understand and voluntarily sign written informed consent. 4. The surgical method is robotic assisted transanal total mesorectal excision 5. Distance of the edge of the tumour within 8 cm Exclusion Criteria: 1. The patient cannot tolerate the operation. 2. Refusal to sign informed consent. 3. Patients with distant metastasis of rectal cancer. 4. The surgical method was changed to miles or Hartman; 5. Unable to complete the follow - up |
Country | Name | City | State |
---|---|---|---|
China | Daping hospital | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University |
China,
Atallah S, Martin-Perez B, Pinan J, Quinteros F, Schoonyoung H, Albert M, Larach S. Robotic transanal total mesorectal excision: a pilot study. Tech Coloproctol. 2014 Nov;18(11):1047-53. doi: 10.1007/s10151-014-1181-5. Epub 2014 Jun 24. — View Citation
Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219. — View Citation
Lee L, de Lacy B, Gomez Ruiz M, Liberman AS, Albert MR, Monson JRT, Lacy A, Kim SH, Atallah SB. A Multicenter Matched Comparison of Transanal and Robotic Total Mesorectal Excision for Mid and Low-rectal Adenocarcinoma. Ann Surg. 2019 Dec;270(6):1110-1116. doi: 10.1097/SLA.0000000000002862. — View Citation
Ye J, Tian Y, Wang L, Ye Y, Zhang Y, Li F, Liu B, Tong W. [Robotic-assisted transanal total mesorectal excision for lower rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Aug 25;20(8):900-903. Chinese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The local recurrence rates of rectal cancer | The incidence of local recurrence rectal cancer within two years after surgery | Two years after surgery | |
Primary | The incidence of postoperative anastomotic leakage | The incidence of postoperative anastomotic leakage within 30 days after surgery | Within 30 days after surgery | |
Primary | The five-year survival rates | The 5-year survival rates of rectal cancer | Five years after surgery | |
Primary | The distant metastasis rates of rectal cancer | The incidence of distant metastasis rectal cancer within two years after surgery | Five years after surgery |
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