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

Anhui Medical University

Status and phase: Unknown; Phase 2

Conditions: Rectal Cancer

Treatments: Procedure: OTME; Procedure: LNTME

Study type: Interventional

Funder types: Other

Identifiers

NCT02830633

LNTME-01

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

LNTME

Experimental group

Description:

Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients

Treatment:

Procedure: LNTME

OTME

Active Comparator group

Description:

Open TME (OTME) is conducted in rectal cancer patients

Treatment:

Procedure: OTME