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