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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHS-PEG coated collagen patch cohort | Patients diagnosed of colon adenocarcinoma that have ileocolic anastomosis after undergoing a laparoscopic right hemicolectomy surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHS-PEG coated collagen patch | Other | Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing a programmed right laparoscopic hemicolectomy for right colon adenocarcinoma with curative intention at the Virgen Macarena University Hospital during the necessary period of time to achieve the proposed number of patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Gómez Rosado | Contact | 955 00 80 00 | juanc.gomez.rosado.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos Gómez Rosado | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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|
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 |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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