Perioperative and Long-term Outcomes of TEM and TEM-ESDNCT04870931
Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer
An observational study of Perioperative and Long-term Outcomes of TEM and TEM-ESD, run by Konstantinos Kouladouros at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative and Long-term Outcomes of TEM and TEM-ESD
- What is being tested?
- TEM / TEM-ESD
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We analysed all patients who underwent TEM or TEM-ESD in our centers between 2007 and 2021
Who may be able to join
- Patients who underwent TEM or TEM-ESD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Mannheim
Mannheim, Baden-Wurttemberg, 68167
Konstantinos Kouladouros, M.D., +497213833385, konstantinos.kouladouros@umm.de
Georg Kähler, M.D., +497213832061, georg.kaehler@umm.de
About this study
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.
- Being tested
- TEM / TEM-ESD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEM / TEM-ESDProcedure or surgery
Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD
| Study group | Role | What they receive |
|---|---|---|
| TEM-Group | All patients that underwent TEM Receives: Procedure: TEM / TEM-ESD | |
| TEM-ESD-Group | All patients that underwent TEM-ESD Receives: Procedure: TEM / TEM-ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence
Measured: 5 years
Secondary outcomes (6)
en bloc resection
Measured: 5 years
complete en bloc resection
Measured: 5 years
procedure time
Measured: 5 years
perioperative morbidity
Measured: 5 years
long-term adverse events
Measured: 5 years
survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative and Long-term Outcomes of TEM and TEM-ESDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konstantinos Kouladouros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konstantinos Kouladouros, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870931
- Sponsor's protocol ID
- UMM01
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kouladouros K, Baral J. Transanal endoscopic microsurgical submucosal dissection (TEM-ESD) for rectal adenomas: a retrospective cohort study of 145 consecutive cases. Langenbecks Arch Surg. 2022 Sep;407(6):2423-2430. doi: 10.1007/s00423-022-02562-0. Epub 2022 Jun 2.
PubMed 35652960
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer
- ClinicalTrials.gov ID
- NCT04870931
- Acronym / sponsor ID
- UMM01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Konstantinos KouladourosUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEM-Group | – | Procedure: TEM / TEM-ESDAll patients that underwent TEM |
| TEM-ESD-Group | – | Procedure: TEM / TEM-ESDAll patients that underwent TEM-ESD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We analysed all patients who underwent TEM or TEM-ESD in our centers between 2007 and 2021
Key inclusion criteria (1 listed)
- Patients who underwent TEM or TEM-ESD
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEM / TEM-ESDTransanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD | Procedure or surgery | TEM-ESD-Group, TEM-Group |
Primary outcome
Local recurrence
Time frame: 5 years
6 secondary outcomes
en bloc resection
Time frame: 5 years
complete en bloc resection
Time frame: 5 years
procedure time
Time frame: 5 years
perioperative morbidity
Time frame: 5 years
long-term adverse events
Time frame: 5 years
survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Derived from this study: PubMed 35652960Kouladouros K, Baral J. Transanal endoscopic microsurgical submucosal dissection (TEM-ESD) for rectal adenomas: a retrospective cohort study of 145 consecutive cases. Langenbecks Arch Surg. 2022 Sep;407(6):2423-2430. doi: 10.1007/s00423-022-02562-0. Epub 2022 Jun 2.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative and Long-term Outcomes of TEM and TEM-ESD, run by Konstantinos Kouladouros at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.