Rectal Neoplasms
Conditions
Keywords
rectal cancer, laparoscopic, taTME, TME
Brief summary
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Detailed description
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.
Interventions
PROCEDUREconventional laparoscopic total mesentery excision
conventional laparoscopic total mesentery excision
PROCEDUREtransanal hybrid-laparoscopic total mesentery excision
transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
Sponsors
Third Military Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven adenocarcinoma of the rectum * Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma * Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI * Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI * Rectal cancer located 3-10 cm from the anal verge
Exclusion criteria
* Metastasis * Obstructing rectal cancer * Synchronous colon cancer * T4 rectal cancer not treated preoperatively with full-course chemoradiation * Pregnant or breast-feeding * Receiving any other study agents * Fecal incontinence * History of prior colorectal cancer * History of inflammatory bowel disease * History of pelvic radiation * BMI \> 40 * Large uterine fibroids * Uncontrolled intercurrent illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens. | 1-6 years | Lymph nodes number; rate of positive circumferential resection margin(CRM); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of 30-day perioperative complications including intraoperative, and postoperative complications | 0-30 days | bleeding, injury of adjacent organs, ileus, leakage, infection |
| Incidence of long-term complications | 1-6 years | incision hernia, |
| Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision. | 1-6 years | overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| sexual functional outcomes | 1-6 years | 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) |
| Quality of life outcomes evaluation | 1-6 years | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) . |
| defecating functional outcomes | 1-6 years | constipation score and incontinence score |
Countries
China
Outcome results
None listed