COX2RCT
A Prospective Randomized Clinical Trial for Comparing Postoperative Pain Following COX-2 and Prostanoids Expression in Women Who Underwent Laparoscopic Surgery for Female Genital Disease
Sponsor study identifier
interventional
60
1 country
1
Study Start
October 17, 2017
Actual (reported)Primary Completion
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2017
Actual (reported)October 24, 2017
Actual (reported)January 5, 2018
Actual (reported)October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Visual analogue scale(VAS) score
every six hours for 48 hours
Numbers of rescue analgesia
From postoperation state to discharge (up to 2 days)
Postoperative complication
From postoperation state to discharge (up to 2 days)
Duration of hospitalization
From postoperation state to discharge (up to 2 days)
Celebrex; COX-2 inhibitor
Ramnos; Lactobacillus casei variety rhamnosus
Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery
Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery
Seoul National University Hospital
Seoul, South Korea
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.
Hee Seung Kim, PhD
Seoul National University Hospital
First Submitted
October 24, 2017
First Posted
January 5, 2018
Study Start
October 17, 2017
Actual (reported)Primary Completion
October 2019
Estimated (date passed)Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
Single-port laparoscopic surgery with CO2 gas
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 5, 2018
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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