Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Procedure: conventional laparoscopic total mesentery excision
* Procedure: transanal hybrid-laparoscopic total mesentery excision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional laparoscopic<br>conventional laparoscopic total mesentery excision surgery for rectal cancer. | Procedure: conventional laparoscopic total mesentery excision<br>* conventional laparoscopic total mesentery excision<br>* Other names: LTME;|
| Experimental: Transanal hybrid-laparoscopic<br>Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer. | Procedure: transanal hybrid-laparoscopic total mesentery excision<br>* 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.<br>* Other names: TLTME;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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); | 1-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of 30-day perioperative complications including intraoperative, and postoperative complications | bleeding, injury of adjacent organs, ileus, leakage, infection | 0-30 days | 
| Incidence of long-term complications | incision hernia, | 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 | 1-6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, laparoscopic, taTME, TME