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

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ClinicalTrials.gov Identifier: NCT02830633
Recruitment Status : Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Han-Hui YAO, 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: LNTME Procedure: OTME Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: LNTME
Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
Procedure: LNTME
Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer

Active Comparator: OTME
Open TME (OTME) is conducted in rectal cancer patients
Procedure: OTME
Patients in this group received traditional open TME for treatment of rectal cancer




Primary Outcome Measures :
  1. Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions. [ Time Frame: postoperative 30 days ]
  2. The postoperative sexual function assessed by IIEF questionnaire [ Time Frame: postoperative one year ]
  3. The postoperative voiding function assessed by IPSS questionnaire. [ Time Frame: postoperative one year ]

Secondary Outcome Measures :
  1. Operative time [ Time Frame: an expected average of 180 minutes ]
  2. Postoperative deaths [ Time Frame: postoperative 30 days ]
  3. The length postoperative hospital stay [ Time Frame: an expected average 8 days ]
  4. C-reactive protein [ Time Frame: postoperative 7 days ]
    serum C-reactive protein level after operation



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830633


Contacts
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Contact: Han-Hui HH YAO, M.D. +86-18956087855 ruoyubaba@163.com
Contact: Liu L LIU, PhD +86-15056017712 liuwkjy@126.com

Sponsors and Collaborators
Anhui Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Han-Hui YAO, M.D., Anhui Medical University
ClinicalTrials.gov Identifier: NCT02830633    
Other Study ID Numbers: LNTME-01
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Han-Hui YAO, Anhui Medical University:
laparoscopy
rectal cancer
pelvic autonomic nerve
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases