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Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.
The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:
The day after surgery, some serum markers are determined by a blood sample.
The markers analyzed are:
Pain level is assessed using the NRS scale at different times:
Other data collected for the study are: gender, age, BMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing Open Tension-free Inguinal Hernia Repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Tension-free Inguinal Hernia Repair | Procedure | A blood sample is taken the day after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair | The study compares post-operative pain, measured with the NRS scale, with CRP (μg/L) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair | The study compares post-operative pain, measured with the NRS scale, with D-dimer (μg/L FEU) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair | The study compares post-operative pain, measured with the NRS scale, with fibrinogen (g/L) levels 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair | The study compares post-operative pain, measured with the NRS scale, with white blood cell count (x 10^9/L) 24 hours after surgery | one day |
| Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair | The study compares post-operative pain, measured with the NRS scale, with Neutrophil to Lymphocyte Ratio (NLR) 24 hours after surgery | one day |
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Inclusion Criteria:
Exclusion Criteria:
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Study population includes patients undergoing Open Tension-free Inguinal Hernia Repair
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Augusto Lauro | Contact | +39 338 8663 879 | augusto.lauro@uniroma1.it | |
| Lauro | Contact | +39 06 499 70684 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusto Lauro | Recruiting | Roma | 000186 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7482166 | Background | Hill AD, Banwell PE, Darzi A, Menzies-Gow N, Monson JR, Guillou PJ. Inflammatory markers following laparoscopic and open hernia repair. Surg Endosc. 1995 Jun;9(6):695-8. doi: 10.1007/BF00187942. | |
| 28831565 | Background | Kokotovic D, Burcharth J, Helgstrand F, Gogenur I. Systemic inflammatory response after hernia repair: a systematic review. Langenbecks Arch Surg. 2017 Nov;402(7):1023-1037. doi: 10.1007/s00423-017-1618-1. Epub 2017 Aug 22. |
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| 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 | May 3, 2023 |
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| 27838831 | Background | Vats M, Pandey D, Saha S, Talwar N, Saurabh G, Andley M, Kumar A. Assessment of systemic inflammatory response after total extraperitoneal repair and Lichtenstein repair for inguinal hernia. Hernia. 2017 Feb;21(1):65-71. doi: 10.1007/s10029-016-1543-1. Epub 2016 Nov 12. |
| 31114292 | Background | Choi HR, Song IA, Oh TK, Jeon YT. Perioperative C-reactive protein is associated with pain outcomes after major laparoscopic abdominal surgery: a retrospective analysis. J Pain Res. 2019 Mar 27;12:1041-1051. doi: 10.2147/JPR.S187249. eCollection 2019. |
| 32300831 | Background | Tarasov DA, Lychagin AV, Yavorovkiy AG, Lipina MM, Tarasova IA. C-reactive protein as marker of post-operative analgesic quality after primary total knee arthroplasty. Int Orthop. 2020 Sep;44(9):1727-1735. doi: 10.1007/s00264-020-04551-8. Epub 2020 Apr 16. |
| 21448308 | Background | Esme H, Kesli R, Apiliogullari B, Duran FM, Yoldas B. Effects of flurbiprofen on CRP, TNF-alpha, IL-6, and postoperative pain of thoracotomy. Int J Med Sci. 2011 Mar 10;8(3):216-21. doi: 10.7150/ijms.8.216. |
| 37731439 | Background | Rathee A, Chaurasia MK, Singh MK, Singh V, Kaushal D. Relationship Between Pre- and Post-Operative C-Reactive Protein (CRP), Neutrophil-to-Lymphocyte Ratio (NLR), and Platelet-to-Lymphocyte Ratio (PLR) With Post-Operative Pain After Total Hip and Knee Arthroplasty: An Observational Study. Cureus. 2023 Aug 20;15(8):e43782. doi: 10.7759/cureus.43782. eCollection 2023 Aug. |
| 37122722 | Background | Shu B, Xu F, Zheng X, Zhang Y, Liu Q, Li S, Chen J, Chen Y, Huang H, Duan G. Change in perioperative neutrophil-lymphocyte ratio as a potential predictive biomarker for chronic postsurgical pain and quality of life: an ambispective observational cohort study. Front Immunol. 2023 Apr 12;14:1177285. doi: 10.3389/fimmu.2023.1177285. eCollection 2023. |
| 31845982 | Background | Gonzalez-Callejas C, Aparicio VA, De Teresa C, Nestares T. Association of Body Mass Index and Serum Markers of Tissue Damage with Postoperative Pain. The Role of Lactate Dehydrogenase for Postoperative Pain Prediction. Pain Med. 2020 Aug 1;21(8):1636-1643. doi: 10.1093/pm/pnz325. |
| Apr 18, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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