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Endoscopic (EID) Versus Surgical (TAMIS) Local Excision for Early Stage Rectal Cancer
Sponsor: Amsterdam UMC, location VUmc
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
Conditions
Interventions
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.
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