Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
1 other identifier
interventional
540
1 country
4
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=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2024
CompletedFirst Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedSeptember 4, 2024
August 1, 2024
1.2 years
August 27, 2024
August 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Anastomotic leakage rates differences between both groups at 30 postoperative days
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).
Through study completion, an average of 1 year
Secondary Outcomes (3)
Postoperative endoluminal bleeding rate differences between both groups.
Through study completion, an average of 1 year
Morbidity differences between groups according to the Clavien-Dindo classification.
Through study completion, an average of 1 year
Re-intervention rate differences between both groups
Through study completion, an average of 1 year
Study Arms (2)
ECPS group
EXPERIMENTALEchelon Circular™ Powered Stapler
MCS Group
ACTIVE COMPARATOR2-row circular staplers manual
Interventions
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
2-row circular staplers manual will be used in colorectal anastomosis.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Diverting stoma.
- Emergency surgery.
- American Society of Anaesthesiologists (ASA) score ≥ IV.
- Transanal total mesorectal excision approach.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
June 27, 2024
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
September 4, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share