NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

NCT01056913 | Completed Phase 4 Results

• 1 other identifier: CT2
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

anastomotic leakage; bleeding from the anastomotic region; anastomotic stenosis

Outcome Measures

Primary Outcomes (1)

• Anastomotic Leakage

  4-8 weeks

Secondary Outcomes (1)

• Clinical Relevant Stenosis

  six months

Study Arms (1)

NITI CAR27 (ColonRing)

OTHER

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

Interventions

Compression Anastomosis Device DEVICE

Restoring intestinal continuity using the NITI CAR27 device

Also known as: ColonRing, BioDynamix Anastomosis

NITI CAR27 (ColonRing)

follow-up colonoscopy OTHER

endoscopic exploration of anastomosis after complete healing

NITI CAR27 (ColonRing)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• benign and malign lesions of the colon and rectum

You may not qualify if:

• advanced peritonitis (putrid, feculent)

Sponsors & Collaborators

• St John of God Hospital, Vienna: lead

Related Publications (1)

• Dauser B, Winkler T, Loncsar G, Herbst F. Compression anastomosis revisited: prospective audit of short- and medium-term outcomes in 62 rectal anastomoses. World J Surg. 2011 Aug;35(8):1925-32. doi: 10.1007/s00268-011-1135-2.

  PMID: 21541799 DERIVED

Related Links

• About BioDynamix Anastomosis

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Rectal Prolapse; Anastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticular Diseases; Gastroenteritis; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Bernhard Dauser (MD)
• Organization: St John of God Hospital Vienna

bernhard.dauser@gmail.com

+43121121

Study Officials

• Friedrich Herbst, MD, FRCS

  St John of God Hospital, Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 24, 2010
• First Posted: January 26, 2010
• Study Start: October 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 29, 2014
• Results First Posted: January 29, 2014

Record last verified: 2013-12