Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

NCT ID: NCT02468362

Last Updated: 2015-06-10

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2019-10-31

Brief Summary

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Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.

Detailed Description

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Conditions

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Low Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laparoscopic group

Group Type ACTIVE_COMPARATOR

laparoscopic intersphincteric resection

Intervention Type PROCEDURE

laparoscopic intersphincteric resection for low rectal cancer

Open group

Group Type ACTIVE_COMPARATOR

open intersphincteric resection

Intervention Type PROCEDURE

Interventions

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laparoscopic intersphincteric resection

laparoscopic intersphincteric resection for low rectal cancer

Intervention Type PROCEDURE

open intersphincteric resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Low rectal cancer below 5 cm from the anal verge
* Fit for laparoscopic total mesorectal excsion
* T2, T3 rectal cancer
* No distant metstasis

Exclusion Criteria

* T1, AND T4
* Distant metastasis
* Tumor infiltrating the dentate line
* unwilling to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Osama Mohammad Ali ElDamshety

surgical oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Eldamshety, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology centre of mansoura university

Sherif Kotb, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology centre of mansoura university

Nazem Shams, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology centre of mansoura university

Ashraf Khater, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology centre of mansoura university

Other Identifiers

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ISR-TME

Identifier Type: -

Identifier Source: org_study_id

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