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Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia

Complete Preservation of Denonvilliers' Fascia

Bing Zeng, M.D.

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.

Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study

IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function

IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function

IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function

IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function

GIQLI questionnaires are used to assess quality of life

Positive Circumferential Resection Margin Rate

Sixth Affiliated Hospital, Sun Yat-sen University

Behaviors and Mental Disorders

Quality of Life

Total mesorectal excision with intraoperative neuromonitoring of pelvic autonomic nerves.

Total mesorectal excision without intraoperative neuromonitoring of pelvic autonomic nerves.

Intraoperative neuromonitoring of pelvic autonomic nerves.

Neuromonitoring

Werner Kneist, Univ.-Prof.

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.

Intraoperative Monitoring of the Pelvic Autonomic Nerves

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.

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

Reduction of FSFI score by at least 8 points 12 months after surgery compared to the preoperative FSFI score per patient.

Reduction of IIEF score by at least 15 points 12 months after surgery compared to the preoperative IIEF score per patient.

Rates of pCRM-positive specimen (distance of tumour from circumferential resection margin (CRM) ≤ 1mm).

Macroscopic assessment of the resection specimen.

Evaluation of fecal incontinence using the Wexner-Vaizey score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer	NCT04672603	Rectal Cancer Advanced Cancer	Complete Preser...	18 Years - 71 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Intraoperative Monitoring of the Pelvic Autonomic Nerves	NCT01585727	Rectal Cancer	TME TME Neuromonitoring	18 Years - 90 Years	Johannes Gutenberg University Mainz

Spots Global Cancer Trial Database for urogenital function