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Endoscopic (EID) Versus Surgical (TAMIS) Local Excision for Early Stage Rectal Cancer

Study acronym: ENSURE
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
In this clinical trial, we compare the endoscopic technique, endoscopic intermuscular dissection (EID), with the surgical technique, transanal minimally invasive surgery (TAMIS) for the treatment of early stage rectal cancer. The aim of this study is to investigate whether one of them leads to better outcomes. Researchers will focus particularly on: * How effectively each technique completely removes the cancer * How quickly patients recover after treatment and whether complications occur * Outcomes after three years (does the cancer go away, or does it come back?) * The impact of both techniques on bowel function and quality of life Participants will: * Be randomly assigned to receive either surgical or endoscopic treatment for their rectal cancer * Keep a diary twice a day to record pain symptoms and recovery during the first 30 days after treatment and complete questionnaires within a 3 year period * Visit the clinic for follow-up appointments within a 3 year period
Trial Details
NCT Number NCT07846046
Lead Sponsor Amsterdam UMC, location VUmc
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions
(from sponsor)
Rectal Cancer Stage I
Related terms Rectal Neoplasms
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov