Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04573738
• Other study ID #: 20200913
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2023
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Perioperative Complication
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Robotic assisted transanal total mesorectal excision
Robotic assisted transanal total mesorectal excision for rectal cancer patients
• Laparoscopic assisted transanal total mesorectal excision
Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients

Locations

Country	Name	City	State
China	Daping hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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