Clinical trial NCT00250328: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Colon Cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Functioning anastomosis without leaks or obstructions
Secondary outcomes:
measure: Functioning anastomosis without stenosis
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Benei-Zion Medical Center
name: Ibrahim Matter, MD
role: PRINCIPAL_INVESTIGATOR
References: