Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer

April 28, 2021 updated by: Konstantinos Kouladouros
We retrospectively analysed all TEM and TEM-ESD procedures that took place in Surgical Clinic of the Municipal Hospital of Karlsruhe and the Surgery Department of the University Hospital of Mannheim from 2007 to 2021. We evaluated the periopüerative and long-term outcomes of both procedures for adenomas, adenocarcinomas and other tumours seperately and we compared the results between the two techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We analysed all patients who underwent TEM or TEM-ESD in our centers between 2007 and 2021

Description

Inclusion Criteria:

  • Patients who underwent TEM or TEM-ESD

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TEM-Group
All patients that underwent TEM
Procedure: TEM / TEM-ESD
Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD
TEM-ESD-Group
All patients that underwent TEM-ESD
Procedure: TEM / TEM-ESD
Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Local recurrence
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
en bloc resection
Time Frame: 5 years
5 years
complete en bloc resection
Time Frame: 5 years
5 years
procedure time
Time Frame: 5 years
5 years
perioperative morbidity
Time Frame: 5 years
5 years
long-term adverse events
Time Frame: 5 years
5 years
survival
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Konstantinos Kouladouros

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMM01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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