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

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
LNTME
OTME
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring laparoscopy, rectal cancer, pelvic autonomic nerve

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LNTME

    OTME

    Arm Description

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

    Open TME (OTME) is conducted in rectal cancer patients

    Outcomes

    Primary Outcome Measures

    Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
    The postoperative sexual function assessed by IIEF questionnaire
    The postoperative voiding function assessed by IPSS questionnaire.

    Secondary Outcome Measures

    Operative time
    Postoperative deaths
    The length postoperative hospital stay
    C-reactive protein
    serum C-reactive protein level after operation

    Full Information

    First Posted
    June 12, 2016
    Last Updated
    July 9, 2016
    Sponsor
    Anhui Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02830633
    Brief Title
    Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2016 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Anhui Medical University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer
    Keywords
    laparoscopy, rectal cancer, pelvic autonomic nerve

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LNTME
    Arm Type
    Experimental
    Arm Description
    Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
    Arm Title
    OTME
    Arm Type
    Active Comparator
    Arm Description
    Open TME (OTME) is conducted in rectal cancer patients
    Intervention Type
    Procedure
    Intervention Name(s)
    LNTME
    Intervention Description
    Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    OTME
    Intervention Description
    Patients in this group received traditional open TME for treatment of rectal cancer
    Primary Outcome Measure Information:
    Title
    Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
    Time Frame
    postoperative 30 days
    Title
    The postoperative sexual function assessed by IIEF questionnaire
    Time Frame
    postoperative one year
    Title
    The postoperative voiding function assessed by IPSS questionnaire.
    Time Frame
    postoperative one year
    Secondary Outcome Measure Information:
    Title
    Operative time
    Time Frame
    an expected average of 180 minutes
    Title
    Postoperative deaths
    Time Frame
    postoperative 30 days
    Title
    The length postoperative hospital stay
    Time Frame
    an expected average 8 days
    Title
    C-reactive protein
    Description
    serum C-reactive protein level after operation
    Time Frame
    postoperative 7 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Han-Hui HH YAO, M.D.
    Phone
    +86-18956087855
    Email
    ruoyubaba@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liu L LIU, PhD
    Phone
    +86-15056017712
    Email
    liuwkjy@126.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29682715
    Citation
    He Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese.
    Results Reference
    derived

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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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