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

• Sponsor: Konstantinos Kouladouros (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04870931
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 13.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative and Long-term Outcomes of TEM and TEM-ESD	Procedure: TEM / TEM-ESD

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Local recurrence [5 years]

Secondary Outcome Measures

1. en bloc resection [5 years]

2. complete en bloc resection [5 years]

3. procedure time [5 years]

4. perioperative morbidity [5 years]

5. long-term adverse events [5 years]

6. survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who underwent TEM or TEM-ESD

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Mannheim	Mannheim	BW	Germany	68167

Sponsors and Collaborators

• Konstantinos Kouladouros

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Konstantinos Kouladouros, Dr. med. Konstantinos Kouladouros, Universitätsmedizin Mannheim
• ClinicalTrials.gov Identifier: NCT04870931
• Other Study ID Numbers: UMM01
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of May 4, 2021