Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2016
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedJuly 13, 2016
July 1, 2016
Same day
June 12, 2016
July 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
postoperative 30 days
The postoperative sexual function assessed by IIEF questionnaire
postoperative one year
The postoperative voiding function assessed by IPSS questionnaire.
postoperative one year
Secondary Outcomes (4)
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
Study Arms (2)
LNTME
EXPERIMENTALLaparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
OTME
ACTIVE COMPARATOROpen TME (OTME) is conducted in rectal cancer patients
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Distant cancer metastasis
- History of abdominal surgery
- With other type of malignancy
- Preoperative voiding dysfunction
- Preoperative sexual dysfunction
- Refusing to attend this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29682715DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
June 12, 2016
First Posted
July 13, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2016
Study Completion
July 1, 2020
Last Updated
July 13, 2016
Record last verified: 2016-07