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

Phase 2

• Conditions: Rectal Cancer
• Interventions: Procedure: OTME; Procedure: LNTME

• Registration Number: NCT02830633
• Lead Sponsor: Anhui Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-12
• Status Verified: 2016-07
• Study Start: 2016-07
• Primary Completion: 2016-07
• Study First Submitted QC: 2016-07-09
• Last Update Submitted: 2016-07-09
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

1. Male patients
2. From 18 years old to 60 years old
3. Normal sexual function
4. Tumor located in rectum (defined as 5- to 12-cm from the anal verge)
5. Pathological confirmed rectal cancer
6. Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
7. Tumor size < 5 cm
8. ASA score was I-II
9. Informed consent was written

Exclusion Criteria

1. Distant cancer metastasis
2. History of abdominal surgery
3. With other type of malignancy
4. Preoperative voiding dysfunction
5. Preoperative sexual dysfunction
6. Refusing to attend this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTME	OTME	Open TME (OTME) is conducted in rectal cancer patients
LNTME	LNTME	Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	postoperative 7 days	serum C-reactive protein level after operation