Comparing outcomes of powered and manual circular staplers in colorectal surgery
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
This study is testing whether a new powered stapler can help people having colorectal surgery heal better and have fewer complications compared to a regular manual stapler.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia Academic / other |
| Locations | 4 sites (Sabadell, Barcelona and 3 other locations) |
| Trial ID | NCT06578065 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Echelon Circular™ Powered Stapler (ECPS) compared to manual circular staplers in patients undergoing colorectal anastomosis. A total of 570 patients will be randomly assigned to either the ECPS group or the manual circular stapler group, with follow-up for 30 days to assess the primary endpoint of anastomotic leakage. The trial aims to determine if the novel design of the powered stapler can reduce technical errors and improve clinical outcomes. The study is multicenter, involving eight sites across Spain and France.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for colorectal anastomosis after specific surgical procedures for benign or malignant conditions.
Not a fit: Patients with diverting stomas, those undergoing emergency surgery, or those with severe comorbidities (ASA score ≥ IV) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing colorectal surgery.
How similar studies have performed: Previous studies have shown promising results with powered staplers in surgical settings, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Diverting stoma. * Emergency surgery. * American Society of Anaesthesiologists (ASA) score ≥ IV. * Transanal total mesorectal excision approach.
Where this trial is running
Sabadell, Barcelona and 3 other locations
- Consorci Corporació Sanitària Parc Taulí de Sabadell — Sabadell, Barcelona, Spain (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Vicente Pla Martí
- Email: vplamarti@yahoo.es
- Phone: +34 669204303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.