Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
18 Years
90 Years
Both
Colon Cancer
Trial Information
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
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 prior to surgery. The preparation will
included Sofodex solution combined with oral neomycin.
3. Aanticoagulation tratment prior surgery- as per specific department regimen.
4. Routine general anesthesia according to standard operation room procedure.
5. Prepare the surgery area according to routine procedure with soap and alcohol. Insert
the trocars.
6. Align the two ends of bowel side-by-side in the same direction or in the opposite
direction. Seal the ends with staples leaving blind loop of no less than 2.5 cm. (1
inch) and make two small enterotomies.
7. The Clip mounted on the Applier should be cooled by immersing it in ice-cold sterile
saline bath for at least 20 seconds.
8. Place the open clip into the prepared enterotomies, each clip coil in one enterotomy.
9. Approximating body temperature, the coils will recover its programmed shape applying
pressure on the tissue.
10. Closure (staple line and enterotomies): closure of the enterotomies with or without
suture inversion of staple lines will be done by using Vicryl suture 3-0 or other
absorbable suture. Postoperative care will be as for conventional treatment.
11. Post operative treatment will be according to the department regimen and in relation to
the patient condition.
The following baseline variables will be recorded for all patients:
1. Demographics, including: gender, age, race, weight and height (BMI), ASA status.
2. Background of disease - presentation, and TNM stage, etc.
3. Region of excised colon.
4. Metastasis yes/no where.
5. Co-morbidities:
Cardiac- (Ischemic heart disease (IHD), Congestive heart failure (CHF), NYHA
Classification I,II,III,IV).
Respiratory- Asthma, Obstructive pulmonary disease (OPD). Diabetes- Type
1(insulin-dependent diabetes), Type 2 (non-insulin-dependent diabetes).
hepatic- Cirrhosis. Alcohol Smoking.
6. Medications.
Follow-up evaluation will be performed every day during hospitalization and one-month, three
months and six months post procedure.
Inclusion Criteria:
1. Patient age over 18 years.
2. Patient schedule for colonic surgery which requires a bowel anastomosis (right colon,
left colon, sigma).
3. Patient is able to understand and to sign the Informed Consent Form.
Exclusion Criteria:
1. Patient has known allergy to nickel.
2. Emergency procedure, i.e. patients with bowel obstruction, bowel strangulation,
peritonitis, bowel perforation, local or systemic infection, ischaemic bowel,
carcinomatosis.
3. Patients with Crohn's disease needed more than one anastomosis.
4. Patient underwent previous major abdominal surgery.
5. Patients under steroid treatment.
6. Patient albumin level less than 3 g/dl
7. Patients under immuno-suppression or cytotoxic treatment.
8. Patients who are participating in another trial which may affect the outcomes data on
this study.
9. Patients with contraindications to general anaesthesia.
10. Patients who refuse consent.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Functioning anastomosis without leaks or obstructions
Principal Investigator
Ibrahim Matter, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Benei-Zion Medical Center
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
HMO-CLP 52-01- HMO-CTIL
NCT ID:
NCT00250328
Start Date:
January 2006
Completion Date:
Related Keywords:
- Colon Cancer
- Colonic Neoplasms
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