Clinical trial NCT02252250: Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
Official title: A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Keywords: rectal cancer
laparoscopic
taTME
TME
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* BMI \> 40
* Large uterine fibroids
* Uncontrolled intercurrent illness

Primary outcomes:
measure: Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
timeFrame: 1-6 years
Secondary outcomes:
measure: Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
timeFrame: 0-30 days
measure: Incidence of long-term complications
timeFrame: 1-6 years
measure: Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
timeFrame: 1-6 years
Other outcomes:
measure: defecating functional outcomes
timeFrame: 1-6 years
measure: sexual functional outcomes
timeFrame: 1-6 years
measure: Quality of life outcomes evaluation
timeFrame: 1-6 years
Locations:
city: Chongqing
country: China
facility: Daping hospital
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: Weidong Tong, Prof
role: PRINCIPAL_INVESTIGATOR
References: