ConditionColorectal Anastomosis
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 groupsSponsors and collaborators
Source ClinicalTrials.gov