Adenocarcinoma Colon Clinical Trial
— ANASTOPATCHOfficial title:
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.
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 15, 2020 |
Est. primary completion date | December 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Virgen Macarena | Sevilla |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |