Intraoperative Monitoring of the Pelvic Autonomic Nerves

NCT ID: NCT01585727

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TME with neuromonitoring

Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.

Group Type: EXPERIMENTAL

TME

Intervention Type: PROCEDURE

Total mesorectal excision

Neuromonitoring

Intervention Type: PROCEDURE

Intraoperative neuromonitoring of pelvic autonomic nerves.

TME without neuromontoring

Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.

Group Type: ACTIVE_COMPARATOR

TME

Intervention Type: PROCEDURE

Total mesorectal excision

Interventions

TME

Total mesorectal excision

Intervention Type: PROCEDURE

TME

Total mesorectal excision

Intervention Type: PROCEDURE

Neuromonitoring

Intraoperative neuromonitoring of pelvic autonomic nerves.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Werner Kneist

Senior physician, Department of Visceral and Abdominal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Werner Kneist, Univ.-Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Visceral and Abdominal Surgery, University Medical Center Mainz

Locations

Department of General and Visceral Surgery, University Medical Center Mainz

Mainz, , Germany

Countries

Germany

References

Kauff DW, Kronfeld K, Gorbulev S, Wachtlin D, Lang H, Kneist W. Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial. BMC Cancer. 2016 May 21;16:323. doi: 10.1186/s12885-016-2348-4.

Reference Type: DERIVED

PMID: 27209237 (View on PubMed)

Other Identifiers

2007-012

Identifier Type: -

Identifier Source: org_study_id

KN 930/1-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id