Clinical trial: NCT05390684
Section: Confidentiality
Subsections: 7. How Will My Personal Data Be Managed?

All the information collected will be treated in accordance with the provisions of Organic Law 15/99, on the protection of personal data. No personal data will be included in the study database: neither your name, nor your medical record number, nor any data that can identify you. You will be identified by a code that only the research team will be able to associate with your name. Only the research team will have access to your medical record data and no one outside the center will be able to consult your record. To exercise your right of access, rectification, cancellation and opposition regarding your data obtained during the study, you must contact the principal investigator. The conclusions of the study will be presented at congresses and scientific publications, but they will always be done with grouped data and nothing that can identify you will ever be disclosed.
Clinical trial: NCT05390684
Section: Participant Responsibilities
Subsections: 4. What Do I Have To Do If I Decide To Participate?

Remember that your participation is voluntary and if you decide not to participate this will not affect your attendance or your relationship with the researcher and his team. If you decide to participate and as you have been informed, your constants and clinical situation will be evaluated daily according to the usual clinical care and blood tests will be taken similar to those that would be performed if you did not participate in this study.
Clinical trial: NCT05390684
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 5. What Risks Or Inconveniences Does It Entail?|6. Will I Get Any Benefit From My Participation?

As mentioned before, this study intends to evaluate the postoperative results and try to establish a predictive model for the early diagnosis of anastomotic leak or fistula after resection surgery of the stomach and esophagus based on analytical and clinical data. This is intended to establish a model that 1 allows us to approach the earliest diagnosis of this possible complication and thus be able to offer a faster and more effective treatment. To do this, his constants and clinical situation will be evaluated daily according to the usual clinical care and blood tests will be taken similar to those that would be performed if he does not participate in this study, in which different values will be determined in relation to the inflammation and infection used. routinely in routine clinical practice. Risk of blood draw: Blood will be drawn through a needle inserted into one of the veins in your arm. This procedure carries a number of associated risks, including the following: pain, bruising, redness, bleeding, infection, and fainting. However, these risks associated with the extraction of the sample are no more than those associated with the extraction of a blood sample for a routine analysis.

As it is a research study aimed at generating knowledge, it is likely that you will not obtain any benefit from your participation, although you will contribute to the advancement of knowledge and social benefit. You will not receive any financial compensation for your participation.
Clinical trial: NCT05390684
Section: Purpose of Research
Subsections: 2. Why Are You Being Asked To Participate?|3. What Is The Object Of This Study?

Your collaboration is requested as you are over 18 years of age and you are going to undergo surgery to remove the diseased part, in order to later restore the continuity of the digestive tract in your case. You will receive adequate and complementary information about the surgical procedure from your surgeon.

The study has the intention and objective of evaluating postoperative results and trying to establish a predictive model for the early diagnosis of anastomotic leak or fistula after resection surgery of the stomach and esophagus based on analytical and clinical data. This is intended to establish a model that allows us to approach the earliest diagnosis of this possible complication and thus be able to offer a faster and more effective treatment.