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NOT YET RECRUITING
NCT07846046
NA

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

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

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

Official title: Endoscopic Intermuscular Dissection Versus Transanal Minimally Invasive Surgery for Local Excision of Early Rectal Cancer: a Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

246

Start Date

2026-09-01

Completion Date

2032-09-01

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic Intermuscular Dissection (EID)

EID is an endoscopic local excision technique used for the resection of early-stage rectal tumours. The procedure uses a flexible endoscope to dissect between the inner (circular) and outer (longitudinal) muscles of the m. propria leaving the outer rectal wall layers intact. It is performed under conscious sedation by a gastroenterologist.

PROCEDURE

Transanal Minimally Invasive Surgery (TAMIS)

TAMIS is a minimally invasive transanal surgical technique used for the local excision of early-stage rectal tumours. A transanal platform is inserted into the anus to allow access with laparoscopic instruments. The procedure may be performed using a full-thickness or an intermuscular approach, based on tumour characteristics and surgical planning. The procedure is performed under general anesthesia by surgeons.

Locations (19)

NoordWest Ziekenhuisgroep

Alkmaar, Netherlands

Flevoziekenhuis

Almere Stad, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

Antoni Van Leeuwenhoek

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Ijsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Deventer Ziekenhuis

Deventer, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Spaarne Gasthuis

Haarlem, Netherlands

Dijklander Ziekenhuis

Hoorn, Netherlands

Leiden Universitair Medisch Centrum

Leiden, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Laurentius Ziekenhuis

Roermond, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Haaglanden Medisch Centrum

The Hague, Netherlands

University Medical Center Utrecht

Utrecht, Netherlands

Isala

Zwolle, Netherlands