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| ID | Type | Description | Link |
|---|---|---|---|
| KN 930/1-1 | Other Grant/Funding Number | German Research Foundation (DFG) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TME with neuromonitoring | Experimental | Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves. |
|
| TME without neuromontoring | Active Comparator | Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TME | Procedure | Total mesorectal excision |
| |
| TME |
| Measure | Description | Time Frame |
|---|---|---|
| Urogenital function | Increase of IPSS score by at least 5 points observed 12 months after surgery compared to the preoperative IPSS score per patient | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function (females) | Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Kneist, Univ.-Prof. | Department of Visceral and Abdominal Surgery, University Medical Center Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General and Visceral Surgery, University Medical Center Mainz | Mainz | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27209237 | Derived | 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. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Procedure |
Total mesorectal excision |
|
| Neuromonitoring | Procedure | Intraoperative neuromonitoring of pelvic autonomic nerves. |
|
| 12 months |
| Adverse events | Occurrence of adverse events. | 12 months |
| Oncological safety | Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm). | 12 months |
| Quality of mesorectal excision | Macroscopic assessment of the resection specimen. | 1 day after the surgery |
| Fecal incontinence | Evaluation of fecal incontinence using the Wexner-Vaizey score | 12 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |