Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

  • STATUS
    Recruiting
  • End date
    May 13, 2023
  • participants needed
    100
  • sponsor
    Third Military Medical University
Updated on 13 May 2022
cancer
rectal carcinoma
pelvic mri
adenocarcinoma
low anterior resection
adenocarcinoma of rectum
total mesorectal excision

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.

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.

Details
Condition Rectal Neoplasms
Treatment conventional laparoscopic total mesentery excision, transanal hybrid-laparoscopic total mesentery excision
Clinical Study IdentifierNCT02252250
SponsorThird Military Medical University
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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