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A Novel Adaptive Anastomotic Technique for Left-sided Colonic Resection

ConditionColon Neoplasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

The goal of this pilot clinical trial is provide preminary evidence of the effectiveness of the C-REX device, developed by CarpoNovum AB, in preventing anastomotic leak and improving anastomosis healing after sigmoid or high rectal resection in patients with colon neoplasia. The primary aim of the study is to evaluate the rate of anastomotic leak in patients receiving the study device within 90 days from the surgical procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged equal or more than 18 years old, both men and women.

Patients with a proven diagnosis of sigmoid colon or high rectal tumors requiring anterior rectal resection as procedure of choice (colorectal cancer or benign polyps), as confirmed by radiological and histological exams.

Patient indicated to minimally invasive or open sigmoid or high rectal resection.

Disqualifiers

Patients with pre-existing health conditions requiring surgery, such as intestinal obstruction or perforation, local or systemic infections, peritonitis, or intestinal ischemia. Patients with intraoperative evidence of any of these conditions will be withdrawn from the study.

Patients with preoperative evidence of distal metastasis. Patients with intraoperative evidence of distal metastasis or peritoneal carcinosis will be withdrawn from the study.

Patients with documented intestinal or anal stenosis or other obstructions distal to the anastomosis. Patients with intraoperative evidence of intestinal or anal stenosis will be withdrawn from the study.

Patients who received radiation therapy to organs in abdomen or pelvis unrelated to current colorectal condition.

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgical device

    Device

    The C-REX device consists of an invasive surgical part, including two anastomotic rings, and surgical instruments for assisting the placement of the anastomotic ring to intestine. The rings are loosen from the inside of the intestinal wall and expelled with faeces per rectum once the anastomosis is healed in approximately ten days.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: C-REX armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Anastomotic leak rate

Rate of radiologically confirmed anastomotic leaks and their severity according to the International Study Group of Rectal Cancer (ISGR) grade

Time frame
90 days after surgery

Secondary outcomes

1

Intraoperative anastomotic failures

Rate of intraoperative anastomotic construction failures, as confirmed by positive air leak test, reverse air leak test, or C-REX integrity pressure test after anastomosis construction

Time frame
Intraoperative
2

Time of anastomosis construction

Median time (in minutes) required to construct the anastomosis using the C-REX device

Time frame
Intraoperative
3

Time of C-REX evacuation

Median time required to evacuate the anastomotic ring of the C-REX device, in days

Time frame
Ten days after surgery
4

Anastomosis stenosis incidence rate

Incidence rate of anastomotic stenosis, as confirmed by digital endoscopy

Time frame
90 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Clinico Humanitas

Lead sponsor

Carponovum AB

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: