Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this 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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Diverting stoma.

Emergency surgery.

American Society of Anaesthesiologists (ASA) score ≥ IV.

Transanal total mesorectal excision approach.

Trial design

Treatments tested in this trial

  • Echelon Circular™ Powered Stapler
  • 2-row circular staplers manual

Treatment groups

540 Participants
are divided into 2 treatment groups

Locations

4
Consorci Corporació Sanitària Parc Taulí de Sabadell08208, SabadellBarcelona, Spain
Hospital General Universitario Gregorio Marañón28007, Madrid Spain
Hospital Clínico Universitario Virgen de la Arrixaca30120, Murcia Spain
Hospital Clínico Universitario de Valencia46010, Valencia Spain

Sponsors and collaborators

Fundación para la Investigación del Hospital Clínico de Valencia

Lead sponsor