Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

Study Overview
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Brief Summary
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TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME). In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.

Official Title
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Preservation Versus Excision of Denonvilliers Fascia in Laparoscopic Pelvic Autonomic Nerve Preserving Surgery for Male Mid-low Rectal Cancer Patients: a Randomized Controlled Clinical Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Preservation of Denonvilliers Fascia
* Procedure: Excision of Denonvilliers Fascia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from over 20 to under 60 years; Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy; Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition; Expected curative resection through L-PANP; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale; ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent; Urinary and sexual function normal preoperatively Exclusion Criteria: Severe mental disorder; History of previous pelvic surgery; Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging; History of other malignant disease within past five years; History of unstable angina or myocardial infarction within past six months; History of cerebrovascular accident within past six months; History of continuous systematic administration of corticosteroids within one month; Contraindication of heart, brain, lung, etc dysfunction; Requirement of simultaneous surgery for other disease; Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer; Rectal cancer invades surrounding tissues; Existence of genuine incontinence or severe stress incontinence preoperatively

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservation of Denonvilliers Fascia<br>Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients | Procedure: Preservation of Denonvilliers Fascia<br>* In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia<br>|
| Active Comparator: Excision of Denonvilliers Fascia<br>Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients | Procedure: Excision of Denonvilliers Fascia<br>* In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 30 days | 
| Sexual function | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function | 30 days | 
| 3-year disease free survival rate |  | 36 months | 
| 5-year disease free survival rate |  | 60 months | 
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 36 months | 
| Sexual function | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity |  | 30 days | 
| 3-year overall survival rate |  | 36 months | 
| 3-year recurrence pattern |  | 36 months | 
| Mortality |  | 30 days | 
| Morbidity |  | 36 months | 
| Mortality |  | 36 months | 
| 5-year overall survival rate |  | 60 months | 
| 5-year recurrence pattern |  | 60 months |