Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

Third Military Medical University70 enrolled

Overview

To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Neoplasms

Interventions

conventional laparoscopic total mesentery excisionPROCEDURE

conventional laparoscopic total mesentery excision

transanal hybrid-laparoscopic total mesentery excisionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Daping hospital

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.

Lymph nodes number; rate of positive circumferential resection margin(CRM);

Time frame: 1-6 years

Secondary Outcomes

Incidence of 30-day perioperative complications including intraoperative, and postoperative complications

bleeding, injury of adjacent organs, ileus, leakage, infection

Time frame: 0-30 days

Incidence of long-term complications

incision hernia,

Time frame: 1-6 years

Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.

overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate

Time frame: 1-6 years

Data from ClinicalTrials.gov

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