Status:
UNKNOWN
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Colon Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The study involves adult subject requiring colonic anastomosis following laparoscopic intra-corporeal surgery. The anastomosis will be performed by using nitinilclip by the LapCAC device instead of st...
Detailed Description
The following steps are to be performed during the NiTi LapCAC surgical procedure. 1. Prophylactic antibiotic - as per specific department regimen. 2. Bowel preparation will be performed one-day prio...
Eligibility Criteria
Inclusion
- Patient age over 18 years.
- Patient schedule for colonic surgery which requires a bowel anastomosis (right colon, left colon, sigma).
- Patient is able to understand and to sign the Informed Consent Form.
Exclusion
- Patient has known allergy to nickel.
- Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischaemic bowel, carcinomatosis.
- Patients with Crohn's disease needed more than one anastomosis.
- Patient underwent previous major abdominal surgery.
- Patients under steroid treatment.
- Patient albumin level less than 3 g/dl
- Patients under immuno-suppression or cytotoxic treatment.
- Patients who are participating in another trial which may affect the outcomes data on this study.
- Patients with contraindications to general anaesthesia.
- Patients who refuse consent.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00250328
Start Date
January 1 2006
Last Update
November 8 2005
Active Locations (1)
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1
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel