Perioperative Complication, Rectal Cancer
Conditions
Keywords
Rectal Cancer, Robotic surgery
Brief 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.
Detailed 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.
Interventions
PROCEDURERobotic assisted transanal total mesorectal excision
Robotic assisted transanal total mesorectal excision for rectal cancer patients
Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
Sponsors
Third Military Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The local recurrence rates of rectal cancer | Two years after surgery | The incidence of local recurrence rectal cancer within two years after surgery |
| The incidence of postoperative anastomotic leakage | Within 30 days after surgery | The incidence of postoperative anastomotic leakage within 30 days after surgery |
| The five-year survival rates | Five years after surgery | The 5-year survival rates of rectal cancer |
| The distant metastasis rates of rectal cancer | Five years after surgery | The incidence of distant metastasis rectal cancer within two years after surgery |
Countries
China
Outcome results
None listed