A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Neoplasms
- Sponsor
- Third Military Medical University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Weidong Tong
Dr
Third Military Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Time Frame: 1-6 years
Lymph nodes number; rate of positive circumferential resection margin(CRM);
Secondary Outcomes
- Incidence of long-term complications(1-6 years)
- Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.(1-6 years)
- Incidence of 30-day perioperative complications including intraoperative, and postoperative complications(0-30 days)