NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

NCT01056913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2014-01-29

Study results available
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Summary

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.

Conditions

  • Colonic Neoplasms
  • Rectal Neoplasms
  • Diverticulitis
  • Inflammatory Bowel Diseases
  • Rectal Prolapse

Interventions

DEVICE

Compression Anastomosis Device

Restoring intestinal continuity using the NITI CAR27 device

OTHER

follow-up colonoscopy

endoscopic exploration of anastomosis after complete healing

Sponsors & Collaborators

  • St John of God Hospital, Vienna

    lead OTHER

Principal Investigators

  • Friedrich Herbst, MD, FRCS · St John of God Hospital, Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056913 on ClinicalTrials.gov