Acute Kidney Injury Clinical Trial
— REPAREOfficial title:
Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction: The REPARE-study
NCT number | NCT04143776 |
Other study ID # | 1 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | December 30, 2020 |
Verified date | February 2023 |
Source | Bispebjerg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An incisional hernia is technically challenging to operate and is the most frequent long-term complication after open surgery, resulting in impaired quality of life and reduced physical ability. Large hernias contain large amounts of abdominal volume, which similarly are missing from the abdominal cavity. Due to adaptations of the abdominal wall muscles and decreased space in the abdominal cavity, abdominal wall reconstruction lead to increased tension and thereby increased intraabdominal pressure. Reduced renal and lung function after surgery is one of the leading causes of prolonged hospitalization, increased costs and mortality. Elevated intraabdominal pressure is a known risk factor for kidney injury, but relationships between hernia surgery, increased intraabdominal pressure, renal and lung function are still unclear. Therefore, in patients undergoing surgery for incisional hernia, we will investigate the extent and consequences of elevated intraabdominal pressure, as well as its relation to renal injury and reduced lung function. We will also investigate the relationship between hernia dimensions and the development of increased intraabdominal pressure, as well as identifying patients at particular risk of developing elevated intraabdominal pressure. From April 2020 to October 2021, we will include 100 patients at Bispebjerg Hospital, Denmark, diagnosed with medium to giant incisional hernia, who will undergo scheduled surgery. Patients are followed from before to 30 days after surgery. They will be examined with CT scans before and after surgery. Blood tests, pulmonary function tests and measurement intraabdominal pressure will be performed before and until 3 days after surgery. Thirty days after surgery, lung function tests and blood tests are repeated at a final examination at the out-patient clinic. During follow-up, differences in hospital stay, complications, reoperations, and mortality will be investigated. Participation in the project is not associated with any side effects and risks. The study is expected great scientific gain, as the results can help identify particularly vulnerable patients in need of extended observation and treatment. The results obtained by the project are sought to be published in relevant scientific journals and conferences. The project is expected to extend over a 3-year period, which will include commissioning, data collection, analytical processing, dissemination of results and conduction of PhD thesis.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Horizontal fascial defects of >8 cm defined by preoperative CT scan - Planned elective open incisional hernia repair Exclusion Criteria: - Pregnancy - Previous bladder resection or reconstruction - Chronic catheter use - Inability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Digestive Disease Center, Bispebjerg Hospital | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Bispebjerg Hospital |
Denmark,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraabdominal hypertension after abdominal reconstruction | The primary aim is to investigate changes in the intraabdominal pressure after abdominal reconstruction. | Before surgery, on postoperative day 1, 2 and 3. | |
Primary | Pulmonary function in intraabdominal hypertension after abdominal reconstruction | The primary aim is to investigate changes in the pulmonary areal after abdominal reconstruction through pre- and postoperative CT scans. | Before surgery, on postoperative day 30. | |
Primary | Surgical complications and intraabdominal hypertension after abdominal reconstruction | The primary aims are to estimate length of stay in patients with and without intraabdominal hypertension. | From surgery to postoperative day 30. | |
Secondary | Intraabdominal hypertension after abdominal reconstruction | Secondary aims are to estimate the risk of intraabdominal hypertension in correlation with loss of domain defined by preoperative CT scans and to estimate the incidence of AKI in patients with and without intraabdominal hypertension. | Before surgery, on postoperative day 1, 2 and 3. | |
Secondary | Pulmonary function in intraabdominal hypertension after abdominal reconstruction | Secondary aims are to investigate immediate intraoperative changes in inspiratory peak pressures before and after primary fascial closure and estimate the incidence of postoperative restrictive pulmonary dysfunction. | Before surgery, during surgery, on postoperative day 1, 2, 3 and 30. | |
Secondary | Surgical complications and intraabdominal hypertension after abdominal reconstruction | Secondary aims are to investigate complications, reoperations and 30-day mortality in patients with and without intraabdominal hypertension. Furthermore, to evaluate predicting factors of intraabdominal hypertension in relation to hernia dimensions, comorbidities and surgical procedures. | From surgery to postoperative day 30. Predicting factors are assessed preoperatively. |
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