Status:
RECRUITING
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Conditions:
Colorectal Anastomosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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=...
Detailed Description
Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together...
Eligibility Criteria
Inclusion
- Patient or its legal representative informed consent.
- Age ≥ 18 years.
- Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).
Exclusion
- Diverting stoma.
- Emergency surgery.
- American Society of Anaesthesiologists (ASA) score ≥ IV.
- Transanal total mesorectal excision approach.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06578065
Start Date
June 27 2024
End Date
September 1 2026
Last Update
September 4 2024
Active Locations (4)
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1
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, Spain, 08208
2
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
3
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
4
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010