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

A

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)

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

Trial contacts and locations

0

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Central trial contact

Han-Hui HH YAO, M.D.; Liu L LIU, PhD

Data sourced from clinicaltrials.gov

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