Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: LNTME
* Procedure: OTME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients From 18 years old to 60 years old Normal sexual function Tumor located in rectum (defined as 5- to 12-cm from the anal verge) Pathological confirmed rectal cancer Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual Tumor size < 5 cm ASA score was I-II Informed consent was written Exclusion Criteria: Distant cancer metastasis History of abdominal surgery With other type of malignancy Preoperative voiding dysfunction Preoperative sexual dysfunction Refusing to attend this trial

Ages Eligible for Study
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Minimum Age: 18 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: LNTME<br>Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients | Procedure: LNTME<br>* Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer<br>|
| Active Comparator: OTME<br>Open TME (OTME) is conducted in rectal cancer patients | Procedure: OTME<br>* Patients in this group received traditional open TME for treatment of rectal cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions. |  | postoperative 30 days | 
| The postoperative sexual function assessed by IIEF questionnaire |  | postoperative one year | 
| The postoperative voiding function assessed by IPSS questionnaire. |  | postoperative one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | an expected average of 180 minutes | 
| Postoperative deaths |  | postoperative 30 days | 
| The length postoperative hospital stay |  | an expected average 8 days | 
| C-reactive protein | serum C-reactive protein level after operation | postoperative 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, rectal cancer, pelvic autonomic nerve