Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
NCT ID: NCT02830633
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2016-07-31
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LNTME
Laparoscopy-assisted nerve-preserved TME (LNTME) is conducted in rectal cancer patients
LNTME
Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
OTME
Open TME (OTME) is conducted in rectal cancer patients
OTME
Patients in this group received traditional open TME for treatment of rectal cancer
Interventions
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LNTME
Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
OTME
Patients in this group received traditional open TME for treatment of rectal cancer
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
MALE
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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Han-Hui YAO
M.D.
Central Contacts
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References
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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.
Other Identifiers
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LNTME-01
Identifier Type: -
Identifier Source: org_study_id
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