Colorectal AnastomosisNCT06578065
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.
A study testing Echelon Circular™ Powered Stapler and 2-row circular staplers manual in people with Colorectal Anastomosis, run by Fundación para la Investigación del Hospital Clínico de Valencia at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Anastomosis
- What is being tested?
- Echelon Circular™ Powered Stapler and 2-row circular staplers manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 4 sitesSpain
- Study dates
- 27 Jun 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Diverting stoma.
- Emergency surgery.
- American Society of Anaesthesiologists (ASA) score ≥ IV.
- Transanal total mesorectal excision approach.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites, 4 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Luis Miguel Jiménez Gómez, luismijg@gmail.com
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
Jesús Abrisqueta, j_abris@hotmail.com
- Not yet recruiting
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
Anna Serracant Barrera, annserracant@gmail.com
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Vicente Pla Martí, +34 669204303, vplamarti@yahoo.es
About this study
Official title: Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
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.
Read the 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 with an increase in morbidity and mortality.
The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.
This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.
540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).
Anastomosis could be performed open, laparoscopically or with robotic assistance.
After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.
- Conditions
- Colorectal Anastomosis
- Being tested
- Echelon Circular™ Powered Stapler, 2-row circular staplers manual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echelon Circular™ Powered StaplerDevice
Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.
2-row circular staplers manualDevice
2-row circular staplers manual will be used in colorectal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| ECPS group | Experimental | Echelon Circular™ Powered Stapler Receives: Device: Echelon Circular™ Powered Stapler |
| MCS Group | Active comparator | 2-row circular staplers manual Receives: Device: 2-row circular staplers manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Postoperative endoluminal bleeding rate differences between both groups.
To assess whether ECPS improve haemostasis in the anastomotic line
Measured: Through study completion, an average of 1 year
Morbidity differences between groups according to the Clavien-Dindo classification.
To evaluate whether ECPS have an impact in postoperative morbidity
Measured: Through study completion, an average of 1 year
Re-intervention rate differences between both groups
To evaluate whether ECPS have an impact in re-interventions rate
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start27 Jun 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, open-label, controlled with parallel groups clinical trial
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578065
- Sponsor's protocol ID
- EPCS-01-22
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers. A Randomized Multicentre Controlled Trial.
- ClinicalTrials.gov ID
- NCT06578065
- Acronym / sponsor ID
- EPCS-01-22
- Conditions
- Colorectal Anastomosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 with an increase in morbidity and mortality.
The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.
This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.
540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).
Anastomosis could be performed open, laparoscopically or with robotic assistance.
After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter, randomized, open-label, controlled with parallel groups clinical trial
| Arm | Type | Receives |
|---|---|---|
| ECPS group | Experimental | Device: Echelon Circular™ Powered StaplerEchelon Circular™ Powered Stapler |
| MCS Group | Active comparator | Device: 2-row circular staplers manual2-row circular staplers manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- Diverting stoma.
- Emergency surgery.
- American Society of Anaesthesiologists (ASA) score ≥ IV.
- Transanal total mesorectal excision approach.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echelon Circular™ Powered StaplerEchelon Circular™ Powered Stapler will be used in colorectal anastomosis. | Device | ECPS group |
| 2-row circular staplers manual2-row circular staplers manual will be used in colorectal anastomosis. | Device | MCS Group |
Primary outcome
Anastomotic leakage rates differences between both groups at 30 postoperative days
Time frame: Through study completion, an average of 1 year
To assess whether ECPS have an impact on left-sided colorectal AL rate compared to current manual circular staplers (MCS).
3 secondary outcomes
Postoperative endoluminal bleeding rate differences between both groups.
Time frame: Through study completion, an average of 1 year
Morbidity differences between groups according to the Clavien-Dindo classification.
Time frame: Through study completion, an average of 1 year
Re-intervention rate differences between both groups
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Anastomosis
Not yet recruiting
FLuorescent Angiography in REduction of Anastomotic Leak in Rectal Cancer Surgery
Rectal Cancer Patients, Rectal Cancer Surgery
Enrolling by invitation
Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study
Low Rectal Cancer, Rectal Neoplasms
RecruitingObservational study
Surgical Intuition in Anastomotic Leakage After Colorectal Surgery
Anastomotic Leaks
Recruiting
Perioperative Biomarkers in Colorectal and Gastric Cancer Surgery
Colorectal (Colon or Rectal) Cancer, STOMACH NEOPLASM
Recruiting
ColoSeal™ ICD System Safety and Feasibility Studies
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echelon Circular™ Powered Stapler and 2-row circular staplers manual in people with Colorectal Anastomosis, run by Fundación para la Investigación del Hospital Clínico de Valencia at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicente Pla Martí (+34 669204303, vplamarti@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage rates differences between both groups at 30 postoperative days (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.