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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00250328
First received: November 6, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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 Intervention Phase
Colon Cancer
Device: LapCAC Laparoscopic Compression Anastomosis Clip
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Functioning anastomosis without leaks or obstructions

Secondary Outcome Measures:
  • Functioning anastomosis without stenosis

Estimated Enrollment: 40
Study Start Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250328

Contacts
Contact: Ibrahim Matter, MD 04-8359137 matardoc@gmail.com

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert,, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Nacum Beglibter         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ibrahim Matter, MD Benei-Zion Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250328     History of Changes
Other Study ID Numbers: HMO-CLP 52-01- HMO-CTIL
Study First Received: November 6, 2005
Last Updated: November 6, 2005
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014