Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250328
Recruitment Status : Unknown
Verified November 2005 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 8, 2005
Last Update Posted : November 8, 2005
Information provided by:
Hadassah Medical Organization

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 staplers.

Endpoints: safety-Functioning secured anastomosis and no occurrence of adverse event related to device use.

The efficacy endpoint of this study includes clinical evaluation of characteristic parameters related to intestinal surgeries.

Discharge day (or ready-for-discharge) Proven anastomotic leak rate (clinically or radiological) Stenosis / stricture at anastomosis Patient recovery level will be assessed every day during hospitalization and in the follow up visits.

Condition or disease Intervention/treatment Phase
Colon Cancer Device: LapCAC Laparoscopic Compression Anastomosis Clip Phase 1

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
Study Start Date : January 2006

Primary Outcome Measures :
  1. Functioning anastomosis without leaks or obstructions

Secondary Outcome Measures :
  1. Functioning anastomosis without stenosis

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250328

Contact: Ibrahim Matter, MD 04-8359137

Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert,, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Nacum Beglibter         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Ibrahim Matter, MD Benei-Zion Medical Center Identifier: NCT00250328     History of Changes
Other Study ID Numbers: HMO-CLP 52-01- HMO-CTIL
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: November 8, 2005
Last Verified: November 2005