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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LNTME

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

Group Type EXPERIMENTAL

LNTME

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

OTME

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

OTME

Patients in this group received traditional open TME for treatment of rectal cancer

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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Han-Hui YAO

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Han-Hui HH YAO, M.D.

Role: CONTACT

+86-18956087855

Liu L LIU, PhD

Role: CONTACT

+86-15056017712

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.

Reference Type DERIVED
PMID: 29682715 (View on PubMed)

Other Identifiers

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LNTME-01

Identifier Type: -

Identifier Source: org_study_id

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