Comparing outcomes of powered and manual circular staplers in colorectal surgery
Official title: Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
Run by Fundación para la Investigación del Hospital Clínico de Valencia · NCT06578065 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 540 (estimated) |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia Academic / other |
| Locations | 4 sites (Sabadell, Barcelona and 3 other locations) |
| Status | Recruiting |
| Started | June 27, 2024 |
| Main results expected | September 1, 2027 |
| Study ends | September 1, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06578065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with powered staplers in surgical settings, suggesting potential for success in this novel application.
Who can join: the full rules
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 it's running
-
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 -
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, Spain Not yet recruiting
Study contacts
- Study coordinator: Vicente Pla Martí
- Email: vplamarti@yahoo.es
- Phone: +34 669204303
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Oral antibiotics before colorectal surgery in children
This study tests whether giving children oral antibiotics before elective colorectal surgery improves recovery and lowers complications.
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Early regular diet versus clear fluids for recovery after colorectal anastomosis
This trial will test whether starting a regular diet soon after a colorectal anastomosis helps people recover bowel function faster and leave the hospital sooner compared with the usual clear fluids approach.
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Single-stapled colorectal anastomosis for left-sided colon surgery.
This will try a single-stapled method to reconnect the colon in adults having planned left-sided colorectal surgery to see if it lowers the risk of leaks compared with the usual double-stapled method.
-
Signia circular stapler for left-sided colon, sigmoid, and rectal resections
This study will try the Signia circular stapler with Tri-Staple technology to see if it safely creates bowel reconnections in adults having left-sided colon, sigmoid, or rectal surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.