Intraoperative Monitoring of the Pelvic Autonomic Nerves (NEUROS)

J

Johannes Gutenberg University (JGU)

Status

Completed

Conditions

Rectal Cancer

Treatments

Procedure: TME
Procedure: Neuromonitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT01585727
2007-012
KN 930/1-1 (Other Grant/Funding Number)

Details and patient eligibility

About

One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME). The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.

Enrollment

188 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

188 participants in 2 patient groups

TME with neuromonitoring
Experimental group
Description:
Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
Treatment:
Procedure: Neuromonitoring
Procedure: TME
TME without neuromontoring
Active Comparator group
Description:
Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
Treatment:
Procedure: TME

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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