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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Echelon Circular™ Powered Stapler

    Device

    Echelon Circular™ Powered Stapler will be used in colorectal anastomosis.

  • 2-row circular staplers manual

    Device

    2-row circular staplers manual will be used in colorectal anastomosis.

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: ECPS groupExperimental treatment 1 intervention
Group B: MCS GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Postoperative endoluminal bleeding rate differences between both groups.

To assess whether ECPS improve haemostasis in the anastomotic line

Time frame
Through study completion, an average of 1 year
2

Morbidity differences between groups according to the Clavien-Dindo classification.

To evaluate whether ECPS have an impact in postoperative morbidity

Time frame
Through study completion, an average of 1 year
3

Re-intervention rate differences between both groups

To evaluate whether ECPS have an impact in re-interventions rate

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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