Actively Recruiting
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2024-09-04
540
Participants Needed
4
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms: * ECPS group: Echelon Circular™ Powered Stapler (n=270) * MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.
CONDITIONS
Official Title
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal representative has given informed consent
- Age 18 years or older
- Scheduled for colorectal anastomosis after left colectomy, sigmoidectomy, anterior rectal resection, or Hartmann reversal for benign or malignant disease
You will not qualify if you...
- Presence of diverting stoma
- Emergency surgery planned
- American Society of Anaesthesiologists (ASA) score of IV or higher
- Surgery using transanal total mesorectal excision approach
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, Spain, 08208
Not Yet Recruiting
2
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
3
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
4
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
V
Vicente Pla Martí
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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