Know Cancer

or
forgot password

Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.


N/A
18 Years
90 Years
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.


Inclusion Criteria:



- informed consent

- histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)

- fit for radical surgery

- total mesorectal excision

- age 18-80 years

Exclusion Criteria:

- history of operation of the urinary tract (e.g. prostatectomy)

- pacemaker

- emergency operation

- multivisceral resection in the pelvis

- partial mesorectal excision

- eligibility for local excision (TEM, intestinal wall resection)

- ongoing infection or sepsis

- severe untreated physical or mental impairment

- pregnancy or breastfeeding

- women of childbearing potential who are not using a highly effective birth control
method

- missing preoperative data on urogenital or anorectal function

- simultaneous participation in another clinical trial

- previous participation in this clinical trial

- lack of cooperation with the trial procedure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Urogenital function

Outcome Description:

Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Werner Kneist, Univ.-Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Visceral and Abdominal Surgery, University Medical Center Mainz

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2007-012

NCT ID:

NCT01585727

Start Date:

June 2012

Completion Date:

December 2015

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • total mesorectal excision
  • pelvic autonomic nerve preservation
  • neurostimulation
  • urogenital function
  • quality of life
  • Rectal Neoplasms

Name

Location