Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. There is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence.
The investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. Secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. The investigators will also identify risk factors associated with acute kidney injury occurrence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esophageal cancer surgery | patients undergoing elective esophageal surgery for cancer |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative acute kidney injury | according to KDIGO criteria | within 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of transient or persistent postoperative acute kidney injury | according KDIGO criteria | 48 hours after development of acute kidney injury |
| Number of patients with renal recovery | according ADQI criteria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All consecutive patients who underwent elective esophageal surgery for cancer
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ilaria Godi, MD | Azienda Ospedaliera di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Padova | Veneto | 35120 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 21, 2021 | Feb 17, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| at 7 days, after 30 days and 3 months |
| Incidence of postoperative pulmonary complications | based on European Perioperative Clinical Outcome (EPCO) definitions | within 30 days after surgery |
| Incidence of major adverse cardiac and cerebrovascular events (MACCE) | composite outcome of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, ischemic stroke | within 30 days after surgery |
| Incidence of sepsis | according Sepsis-3 definition | within 30 days after surgery |
| Mortality in hospital | any death during the admission when the operation was performed | 1 year |
| Increase in length of hospital stay | compared to the expected length of hospital stay according ACS NSQIP calculation | 1 year |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |