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Clinical Trials/NL-OMON32240
NL-OMON32240
Recruiting
Phase 3

TRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS - TREND study

Academisch Medisch Centrum0 sites186 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
rectal adenoma
Sponsor
Academisch Medisch Centrum
Enrollment
186
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • (1\) Diagnosed with a large non\-pedunculated rectal adenoma with a largest diameter of at least 3cm.
  • (2\) The lower and upper borders of the adenoma are located at \>1cm and \<15cm from the anal verge, respectively.
  • (3\) Biopsies of the lesion did not show invasive cancer.
  • (4\) No endoscopic or endoscopic ultrasonographic suspicion for invasive cancer
  • (5\) Synchronous colonic adenomas or cancers are excluded by colonoscopy first.
  • (6\) The general health condition of the patient permits general/spinal anesthesia (ASA I\-III).
  • (7\) Absence of non\-correctable coagulopathy
  • (8\) Patient age of 18 years or older.

Exclusion Criteria

  • (1\) Suspicion for invasive cancer during endoscopy or endoscopic ultrasonography
  • (2\) Proven invasive cancer with biopsies (histology)

Outcomes

Primary Outcomes

Not specified

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