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