Rectal Neoplasms
Conditions
Keywords
transanal surgery, robotic surgery, total mesorectal excision
Brief summary
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.
Detailed description
Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in rectal cancer surgery. However, the narrow angle and limited space of the operation restrict the wide spread of this technique. Da Vinci robotic system has achieved good results in rectal cancer surgery. Robotics may help to overcome technical difficulties in TaTME. The purpose of this study was to explore the availability of Da Vinci robotic-assisted transanal total mesorectal excision(R-TaTME) This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.
Interventions
PROCEDURER-TME
Conventional Robotic Total Mesentery Excision
PROCEDURER-TaTME
Robotic Transanal Total Mesentery Excision
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adenocarcinoma of the rectum by biopsy * the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy * tumor diameter less than 4cm * baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7) * tolerable to surgery * be able to understand and willing to participate in this trial with signature
Exclusion criteria
* history of malignant colorectal neoplasia * recent diagnosis with other malignancies * patients requiring emergency surgery such as obstruction，perforation and bleeding * tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer * preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis * participating in other clinical trails * History of pelvic radiation * BMI \> 40 * Large uterine fibroids * can not tolerate the surgery * history of serious mental illness * pregnancy or lactating women * preoperative uncontrolled infection * the researchers believe the patients should not enrolled in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive rate of circumferential resection margin (CRM) of the specimens | 10 days after surgery | Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while \>1mm is negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hospital stay | 3 years after surgery | recovery information. |
| disease free survival rate | 3 years after surgery | the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. |
| overall survival rate | 3 years after surgery | the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not. |
| the rate of postoperative complications | 30 days after surgery | preoperative safety containing operation information, complication information. |
| The grade score of the specimens integrity | 10 days after surgery | the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see \>5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3. |
| The distance between lower tumor margin and the lower reaction margin | 10 days after surgery | the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life outcomes evaluation | 2 years rafter surgery | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36). |
| defecating functional outcomes | 3 years after surgery | Wexner scale |
| sexual functional outcomes | 2 years after surgery | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF) |
Contacts
Primary Contactfan li, MD.
Outcome results
None listed