Status:

UNKNOWN

Robotic Assisted Transanal Total Mesorectal Excision Surgery for Rectal Cancer in Low Site

Lead Sponsor:

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Conditions:

Rectal Neoplasms

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

To investigates the feasibility, practicability, safety and subjective as well as functional outcome of Robotic transanal total mesentery excision for rectal cancer in low site.

Detailed Description

Transanal total mesorectal excision (TaTME) may offer a better way to achieve radical resection and functional protection for lower rectal cancer, which have been regarded as challenging situations in...

Eligibility Criteria

Inclusion

  • adenocarcinoma of the rectum by biopsy
  • the lower edge of the tumor from the anal margin less than 8cm according to MRI or rigid endoscopy
  • tumor diameter less than 4cm
  • baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
  • tolerable to surgery
  • be able to understand and willing to participate in this trial with signature

Exclusion

  • history of malignant colorectal neoplasia
  • recent diagnosis with other malignancies
  • patients requiring emergency surgery such as obstruction,perforation and bleeding
  • tumor involving adjacent organs, anal sphincter, or levator ani muscle muti-focal colorectal cancer
  • preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence history of inflammatory bowel disease or familial adenomatous polyposis
  • participating in other clinical trails
  • History of pelvic radiation
  • BMI \> 40
  • Large uterine fibroids
  • can not tolerate the surgery
  • history of serious mental illness
  • pregnancy or lactating women
  • preoperative uncontrolled infection
  • the researchers believe the patients should not enrolled in

Key Trial Info

Start Date :

February 15 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2023

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03422835

Start Date

February 15 2018

End Date

December 30 2023

Last Update

February 6 2018

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