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The purpose of this study is to compare postoperative pain following COX-2 and prostanoids expression in women who underwent laparoscopic surgery for female genital disease in order to evaluate the effect of COX-2 on local inflammation, COX-2 and prostanoids expression followed by exposure time to carbon dioxide(CO2) gas, and degree of postoperative pain.
In women who underwent laparoscopic surgery for female genital disease, the effect of COX-2 on local inflammation was assessed by randomization, using the COX-2 inhibitor celecoxib and placebo, comparative evaluation of expression of COX-2 and prostanoids by pre/postoperative peritoneal biopsy and postoperative pain depending on gas exposure time
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COX-2 inhibitor (Celecoxib) | Active Comparator | Celebrex; COX-2 inhibitor |
|
| Placebo drug (Ramnos) | Placebo Comparator | Ramnos; Lactobacillus casei variety rhamnosus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COX-2 inhibitor | Drug | Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of biomarkers expression according to exposure to CO2 gas | Peritoneal biopsy and real-time polymerase chain reaction(RT-PCR), Immunohistochemistry of Biomarkers (COX-2, PGE2, PGF2, PGI2, TXA2) | Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale(VAS) score | Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10) | every six hours for 48 hours |
| Numbers of rescue analgesia | Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Seung Kim, PhD | Contact | 82-2-2072-4863 | bboddi0311@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Kim, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40722854 | Derived | Han KH, Park S, Lee S, Ham J, Lim W, Song G, Kim HS. Upregulation of 15-Hydroxyprostaglandin Dehydrogenase by Celecoxib to Reduce Pain After Laparoendoscopic Single-Site Surgery (POPCORN Trial): A Randomized Controlled Trial. Biomedicines. 2025 Jul 21;13(7):1784. doi: 10.3390/biomedicines13071784. |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D052246 | Cyclooxygenase 2 Inhibitors |
| ID | Term |
|---|---|
| D016861 | Cyclooxygenase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Placebo Oral Tablet | Drug | Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery |
|
| Preoperative peritoneal biopsy | Procedure | Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue) |
|
| Single-port laparoscopic surgery | Procedure | Single-port laparoscopic surgery with CO2 gas |
|
| Postoperative peritoneal biopsy | Procedure | Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue) |
|
| From postoperation state to discharge (up to 2 days) |
| Postoperative complication | nausea, vomiting, etc. | From postoperation state to discharge (up to 2 days) |
| Duration of hospitalization | duration of hospitalization | From postoperation state to discharge (up to 2 days) |
| D020164 | Chemical Actions and Uses |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |