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

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
LapCAC Laparoscopic Compression Anastomosis Clip
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, Israel

Outcomes

Primary Outcome Measures

Functioning anastomosis without leaks or obstructions

Secondary Outcome Measures

Functioning anastomosis without stenosis

Full Information

First Posted
November 6, 2005
Last Updated
November 6, 2005
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00250328
Brief Title
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
Official Title
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) Device for Intra-Corporeal Lap-Colectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.
Detailed Description
The following steps are to be performed during the NiTi LapCAC surgical procedure. Prophylactic antibiotic - as per specific department regimen. Bowel preparation will be performed one-day prior to surgery. The preparation will included Sofodex solution combined with oral neomycin. Aanticoagulation tratment prior surgery- as per specific department regimen. Routine general anesthesia according to standard operation room procedure. Prepare the surgery area according to routine procedure with soap and alcohol. Insert the trocars. 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. The Clip mounted on the Applier should be cooled by immersing it in ice-cold sterile saline bath for at least 20 seconds. Place the open clip into the prepared enterotomies, each clip coil in one enterotomy. Approximating body temperature, the coils will recover its programmed shape applying pressure on the tissue. 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. 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: Demographics, including: gender, age, race, weight and height (BMI), ASA status. Background of disease - presentation, and TNM stage, etc. Region of excised colon. Metastasis yes/no where. 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. Medications. Follow-up evaluation will be performed every day during hospitalization and one-month, three months and six months post procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
LapCAC Laparoscopic Compression Anastomosis Clip
Primary Outcome Measure Information:
Title
Functioning anastomosis without leaks or obstructions
Secondary Outcome Measure Information:
Title
Functioning anastomosis without stenosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Matter, MD
Phone
04-8359137
Email
matardoc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ibrahim Matter, MD
Organizational Affiliation
Benei-Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert,, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Nacum Beglibter

12. IPD Sharing Statement

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

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