Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250328
Status:
UNKNOWN
Last Update Posted:
2005-11-08
First Post:
2005-11-06
Brief Title:
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip LapCAC Device for Intra-Corporeal Lap-Colectomy
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Evaluation of NiTi Laparoscopic Compression Anastomosis Clip LapCAC Device for Intra-Corporeal Lap-Colectomy
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25 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 yesno where
5 Co-morbidities
Cardiac- Ischemic heart disease IHD Congestive heart failure CHF NYHA Classification IIIIIIIV
Respiratory- Asthma Obstructive pulmonary disease OPD Diabetes- Type 1insulin-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
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 25 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 yesno where
5 Co-morbidities
Cardiac- Ischemic heart disease IHD Congestive heart failure CHF NYHA Classification IIIIIIIV
Respiratory- Asthma Obstructive pulmonary disease OPD Diabetes- Type 1insulin-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None