NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

• Sponsor: St John of God Hospital, Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01056913
• Collaborator: (none)
• Enrollment: 62
• Arm: 1
• Duration (Months): 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms; Rectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Rectal Prolapse	Device: Compression Anastomosis Device; Other: follow-up colonoscopy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Compression Anastomosis: Initial Clinical Experience With the ColonRingTM
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: NITI CAR27 (ColonRing)	Device: Compression Anastomosis Device; Restoring intestinal continuity using the NITI CAR27 device; Other Names: ColonRing BioDynamix Anastomosis ; Other: follow-up colonoscopy; endoscopic exploration of anastomosis after complete healing

Outcome Measures

Primary Outcome Measures

1. Anastomotic Leakage [4-8 weeks]

Secondary Outcome Measures

1. Clinical Relevant Stenosis [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• benign and malign lesions of the colon and rectum

Exclusion Criteria:

• advanced peritonitis (putrid, feculent)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• St John of God Hospital, Vienna

Investigators

• Principal Investigator: Friedrich Herbst, MD, FRCS, St John of God Hospital, Vienna

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• About BioDynamix Anastomosis

Publications

None provided.

• Responsible Party: Bernhard Dauser, MD, MD, St John of God Hospital, Vienna
• ClinicalTrials.gov Identifier: NCT01056913
• Other Study ID Numbers: CT2
• First Posted: Jan 26, 2010
• Last Update Posted: Jan 29, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Bernhard Dauser, MD, MD, St John of God Hospital, Vienna: anastomotic leakage; bleeding from the anastomotic region; anastomotic stenosis
• Additional relevant MeSH terms: Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis; Rectal Prolapse; Prolapse

Study Results

Participant Flow

Arm/Group Title	NITI CAR27 (ColonRing)
Arm/Group Description	Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Period Title: Overall Study
STARTED	62
COMPLETED	62
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	NITI CAR27 (ColonRing)
Arm/Group Description	Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Overall Participants	62
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	67
Sex: Female, Male (Count of Participants)
Female	30 48.4%
Male	32 51.6%

Outcome Measures

1. Primary Outcome

Title	Anastomotic Leakage
Time Frame	4-8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NITI CAR27 (ColonRing)
Arm/Group Description	Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
Measure Participants	62
Number [participants]	0 0%

2. Secondary Outcome

Title	Clinical Relevant Stenosis
Time Frame	six months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	NITI CAR27 (ColonRing)
Arm/Group Description	Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing
All Cause Mortality
	NITI CAR27 (ColonRing)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NITI CAR27 (ColonRing)
	Affected / at Risk (%)	# Events
Total	2/62 (3.2%)
Gastrointestinal disorders
Anastomotic stenosis	2/62 (3.2%)	2
Other (Not Including Serious) Adverse Events
	NITI CAR27 (ColonRing)
	Affected / at Risk (%)	# Events
Total	0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.