Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a NHS-PEG Coated Collagen Patch.

Study Overview
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Brief Summary
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The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.

Official Title
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Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.

Conditions
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Adenocarcinoma Colon

Intervention / Treatment
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* Other: NHS-PEG coated collagen patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old. Ability to understand and make their own decision to participate in the study. Pre-surgery right colon adenocarcinoma pathological diagnosis. Patient with a mechanic, intra or extracorporeal ileocolic anastomosis. Exclusion Criteria: Urgent intervention. Simultaneous colon cancer. M1 pre-surgery staging.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NHS-PEG coated collagen patch cohort<br>Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery. | Other: NHS-PEG coated collagen patch<br>* Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.<br>* Other names: Hemopatch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch. | Ileocolic anastomosis leakage existence of evidence and seriousness. | Up to 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch. | Percentage of leaks that occur in the ileocolic anastomosis after being reinforced with NHS-PEG coated collagen patch. | Up to 30 days after the surgery | 
| Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch. | Number and type of complications due to the anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch. | Up to 30 days after the surgery | 
| Number of surgical repetitions. | Number of following surgeries that the patient has to undergo due to the failure of the collagen patch ileocolic anastomosis protection. | Up to 30 days after the surgery | 
| Number of hospital readmissions. | Number of times that the patient has to be rehospitalized due to the failure of the collagen patch ileocolic anastomosis protection. | Up to 30 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon neoplasia, Ascendant colon, Surgical anastomosis, Anastomotic leak, Collagen, Polyethylene glycol, Hemopatch