Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction (REPARE)
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|ClinicalTrials.gov Identifier: NCT04143776|
Recruitment Status : Withdrawn (Currently on standby until new primary investigator is found)
First Posted : October 29, 2019
Last Update Posted : February 27, 2023
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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.
|Condition or disease||Intervention/treatment|
|Hernia, Ventral Hernia Incisional Acute Kidney Injury Restrictive Lung Disease Intraabdominal Hypertension||Procedure: Abdominal reconstruction|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction: The REPARE-study|
|Actual Study Start Date :||June 1, 2020|
|Actual Primary Completion Date :||December 30, 2020|
|Actual Study Completion Date :||December 30, 2020|
- Procedure: Abdominal reconstruction
No restrictions are set on surgical procedures or anaesthetic management.
- Intraabdominal hypertension after abdominal reconstruction [ Time Frame: Before surgery, on postoperative day 1, 2 and 3. ]The primary aim is to investigate changes in the intraabdominal pressure after abdominal reconstruction.
- Pulmonary function in intraabdominal hypertension after abdominal reconstruction [ Time Frame: Before surgery, on postoperative day 30. ]The primary aim is to investigate changes in the pulmonary areal after abdominal reconstruction through pre- and postoperative CT scans.
- Surgical complications and intraabdominal hypertension after abdominal reconstruction [ Time Frame: From surgery to postoperative day 30. ]The primary aims are to estimate length of stay in patients with and without intraabdominal hypertension.
- Intraabdominal hypertension after abdominal reconstruction [ Time Frame: Before surgery, on postoperative day 1, 2 and 3. ]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.
- Pulmonary function in intraabdominal hypertension after abdominal reconstruction [ Time Frame: Before surgery, during surgery, on postoperative day 1, 2, 3 and 30. ]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.
- Surgical complications and intraabdominal hypertension after abdominal reconstruction [ Time Frame: From surgery to postoperative day 30. Predicting factors are assessed preoperatively. ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Horizontal fascial defects of >8 cm defined by preoperative CT scan
- Planned elective open incisional hernia repair
- Previous bladder resection or reconstruction
- Chronic catheter use
- Inability to provide informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143776
|Digestive Disease Center, Bispebjerg Hospital|
|Copenhagen, Denmark, DK-2400|
|Principal Investigator:||Sinor Soltanizadeh, MD||Digestive Disease Center, Bispebjerg Hospital, University of Copenhagen|
|Responsible Party:||Sinor Soltanizadeh, Medical Doctor, Ph.D.-student, Bispebjerg Hospital|
|Other Study ID Numbers:||
|First Posted:||October 29, 2019 Key Record Dates|
|Last Update Posted:||February 27, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||Will be determined later.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
acute kidney injury
restrictive lung disease
Acute Kidney Injury
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases