Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- The postoperative voiding function assessed by IPSS questionnaire.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LNTME
Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
Intervention: LNTME (Procedure)
OTME
Open TME (OTME) is conducted in rectal cancer patients
Intervention: OTME (Procedure)
Outcomes
Primary Outcomes
The postoperative voiding function assessed by IPSS questionnaire.
Time Frame: postoperative one year
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
Time Frame: postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire
Time Frame: postoperative one year
Secondary Outcomes
- 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)
Investigators
Han-Hui YAO
M.D.
Anhui Medical University