Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

NCT ID: NCT02455752

Last Updated: 2015-07-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

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The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

Detailed Description

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This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach.

Data will be registered prospectively and the perioperative outcomes will be assessed.

Conditions

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Total Mesorectal Excision Laparoscopic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reroperitoneal Group

LE-TME

Group Type ACTIVE_COMPARATOR

LE-TME

Intervention Type PROCEDURE

Retroperitoneal approach for total mesorectal excision

Interventions

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LE-TME

Retroperitoneal approach for total mesorectal excision

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery

Exclusion Criteria

* contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West oncologic center, Nantes, France

UNKNOWN

Sponsor Role collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role collaborator

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Osama Mohammad Ali ElDamshety

Assisstant Lecturer of surgical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Eldamshety, PhD

Role: PRINCIPAL_INVESTIGATOR

1-Assistant lecturer of surgical oncology, Mansoura university Egypt. 2-Research Fellow, Policlinico Umberto primo, LA SAPIENZA, Roma, Italy.

Frédéric Dumont, M.D.

Role: PRINCIPAL_INVESTIGATOR

1- Department of Digestive Oncological surgery, West oncologic center, Nantes, France 2- Department of digestive Oncological surgery, Gustave Roussy Cancer Campus, Villejuif, France

Locations

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Oncology center of mansoura university

Al Mansurah, Eldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RTME-200315

Identifier Type: -

Identifier Source: org_study_id

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