Multicenter Study on Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

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. Open PANP (pelvic autonomic nerve preservation) TME 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 PANP TME surgery (O-PANP-TME). Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.

Official Title
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Multicenter Study on Outcomes and Protection of Urinary and Sexual Function of Laparoscopic Versus Open PANP-TME for Male Mid-low Rectal Cancer Patients

Conditions
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Rectum Neoplasms

Intervention / Treatment
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* Procedure: L-PANP-TME
* Procedure: O-PANP-TME


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 both L-PANP-TME and O-PANP-TME; 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: Women during pregnancy or breast-feeding 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 |
| --- | --- |
| Active Comparator: O-PANP-TME<br>Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients | Procedure: O-PANP-TME<br> <br> |
| Experimental: L-PANP-TME<br>Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients | Procedure: L-PANP-TME<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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