NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

St John of God Hospital, Vienna62 enrolled

Overview

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colonic Neoplasms Rectal Neoplasms Diverticulitis Inflammatory Bowel Diseases Rectal Prolapse

Interventions

Compression Anastomosis DeviceDEVICE

Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopyOTHER

endoscopic exploration of anastomosis after complete healing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * benign and malign lesions of the colon and rectum Exclusion Criteria: * advanced peritonitis (putrid, feculent)

Outcomes

Primary Outcomes

Anastomotic Leakage

Time frame: 4-8 weeks

Secondary Outcomes

Clinical Relevant Stenosis

Time frame: six months

Data from ClinicalTrials.gov

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