An interventional study of TME and TME in Rectal Cancer, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Prevention
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 517 are open to participants now.
This study's enrollment of 188 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Johannes Gutenberg University Mainz is the lead sponsor of 153 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.
Procedure: TME · Procedure: Neuromonitoring
Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.
Procedure: TME
Total mesorectal excision
Total mesorectal excision
Intraoperative neuromonitoring of pelvic autonomic nerves.
Urogenital function
Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient
Time frame: 12 months
Sexual function (females)
Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.
Time frame: 12 months
Sexual function (males)
Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.
Time frame: 12 months
Adverse events
Occurrence of adverse events.
Time frame: 12 months
Oncological safety
Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).
Time frame: 12 months
Quality of mesorectal excision
Macroscopic assessment of the resection specimen.
Time frame: 1 day after the surgery
Fecal incontinence
Evaluation of fecal incontinence using the Wexner-Vaizey score
Time frame: 12 months
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Johannes Gutenberg University Mainz