Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer. (ISR-TME)

June 9, 2015 updated by: Osama Mohammad Ali ElDamshety, Mansoura University

Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic group
Procedure: laparoscopic intersphincteric resection
laparoscopic intersphincteric resection for low rectal cancer
Active Comparator: Open group
Procedure: open intersphincteric resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease Free survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Local recurrence
Time Frame: 5 years
5 years
Distant metstasis
Time Frame: 5 years
5 years
5 year survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Osama Eldamshety, PhD, MD, Oncology centre of mansoura university
  • Principal Investigator: Sherif Kotb, PhD, MD, Oncology centre of mansoura university
  • Principal Investigator: Nazem Shams, PhD, MD, Oncology centre of mansoura university
  • Principal Investigator: Ashraf Khater, Phd, MD, Oncology centre of mansoura university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

June 7, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISR-TME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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