Compression Anastomosis Using the CAR™ 27

Not Applicable

Completed

• Conditions: Colorectal Surgery

• Registration Number: NCT00867958
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-02
• Study First Submitted: 2009-03-22
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Status Verified: 2009-05
• Study Completion: 2009-12
• Last Update Submitted: 2011-02-20
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc.	3-mo

Trial Locations

Locations (1)

HaEmek Medical Center; 🇮🇱 Afula, Israel