Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer (TAMIS)

September 10, 2018 updated by: Osama Mohammad Ali ElDamshety

Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study

Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T2 N0 low rectal cancer

Exclusion Criteria:

  • patients unfit for laparoscopic resection
  • Unwilling to share in the study

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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAMIS TME
T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.
Procedure: Transanal minimally invasive total mesorectal excision
Active Comparator: TAMIS-Local
T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.
Procedure: transanal minimally invasive locoregional resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall percent of postoperative complications.
Time Frame: 30 days
the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay
Time Frame: 30 days
Number of Days starting from the admission till discharge
30 days
Recurrence.
Time Frame: 2 years
number of local and distant recurrence
2 years

Collaborators and Investigators

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

Sponsor

Osama Mohammad Ali ElDamshety

Investigators

  • Study Director: Sherif Kotb, M.D., PhD., Professor of surgical oncology Mansoura university
  • Principal Investigator: Osama Eldamshety, PhD, surgical oncology Mansoura university
  • Principal Investigator: Adel Fathi, M.D., surgical oncology 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

June 1, 2015

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 10, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISS-TRICKR2

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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