NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

St John of God Hospital, Vienna

Status and phase: Completed; Phase 4

Conditions: Rectal Prolapse; Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis; Rectal Neoplasms

Treatments: Device: Compression Anastomosis Device; Other: follow-up colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01056913

CT2

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• benign and malign lesions of the colon and rectum

Exclusion criteria

• advanced peritonitis (putrid, feculent)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

62 participants in 1 patient group

NITI CAR27 (ColonRing)

Other group

Treatment:

Other: follow-up colonoscopy

Device: Compression Anastomosis Device