Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
NCT06578065 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540
Last updated 2024-09-04
Summary
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
- Colorectal Anastomosis
Interventions
- DEVICE
-
Echelon Circular™ Powered Stapler
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
- DEVICE
-
2-row circular staplers manual
2-row circular staplers manual will be used in colorectal anastomosis.
Sponsors & Collaborators
-
Fundación para la Investigación del Hospital Clínico de Valencia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-27
- Primary Completion
- 2025-09-01
- Completion
- 2026-09-01
Countries
- Spain
Study Locations
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