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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.
The following steps are to be performed during the NiTi LapCAC surgical procedure.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LapCAC Laparoscopic Compression Anastomosis Clip | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning anastomosis without leaks or obstructions |
| Measure | Description | Time Frame |
|---|---|---|
| Functioning anastomosis without stenosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim Matter, MD | Contact | 04-8359137 | matardoc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ibrahim Matter, MD | Benei-Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization, Jerusalem, Israel | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |