Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Potrero Medical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuryn Monitoring System | Device | Utilization of the Accuryn Monitoring System to measure intraabdominal pressure and urine output during laparoscopic inguinal hernia repair surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraabdominal Pressure | Maximum IAP levels during surgery | 2 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will be derived from the elective, outpatient surgical practice of the department of general surgery at Maimonides Medical Center.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Inguinal Hernia Repair | Intraabdominal pressure monitoring during laparoscopic inguinal hernia repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inguinal Hernia Repair | Intraabdominal pressure monitoring during laparoscopic inguinal hernia repair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraabdominal Pressure | Maximum IAP levels during surgery | Posted | Mean | Standard Deviation | mmHg | 2 hours |
|
|
2 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inguinal Hernia Repair | Intraabdominal pressure monitoring during laparoscopic inguinal hernia repair |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Prien | Maimonides Medical Center | 718-283-6000 | DSherwinter@maimonidesmed.org |
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 | Apr 4, 2018 | Mar 17, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |