Female Genital DiseaseCOX2RCTNCT03391570
Comparing Postoperative Pain Following COX-2 and Prostanoids Expression
A study testing COX-2 inhibitor, Preoperative peritoneal biopsy and Single-port laparoscopic surgery in people with Female Genital Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Female Genital Disease
- What is being tested?
- COX-2 inhibitor, Preoperative peritoneal biopsy and Single-port laparoscopic surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Oct 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, Age ≥ 20 years
- Patients with benign female genital disease who need laparoscopic surgery
- Patients with benign disease who can be treated by single port laparoscopy
- Patients who signed an approved informed consent
Who cannot join
- Female, Age < 20 years
- Pregnancy
- Previous cancer history
- Patients who refuse to sign an informed consent
- Patients with benign female genital disease combined clinical peritonitis (ex. tubo-ovarian abscess, tubo-ovaritis, ruptured endometriosis)
- Patients with malignant female genital disease
- Patients who got surgery with multi-port laparoscopy
- Patients who are contraindicated with COX-2 inhibitors (liver disease, renal disease, active peptic ulcer, active gastrointestinal tract bleeding, ischemic heart disease, hyperkalemia)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Eunji Lee, MD, 82-2-2072-2643, bliss8880103@gmail.com
Hee Seung Kim, PhD, 82-2-2072-4863, bboddi0311@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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
- Conditions
- Female Genital Disease
- Being tested
- COX-2 inhibitor, Placebo Oral Tablet, Preoperative peritoneal biopsy, Single-port laparoscopic surgery, Postoperative peritoneal biopsy
- Keywords
- Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COX-2 inhibitorDrug
Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery
Placebo Oral TabletDrug
Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery
Preoperative peritoneal biopsyProcedure or surgery
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
Single-port laparoscopic surgeryProcedure or surgery
Single-port laparoscopic surgery with CO2 gas
Postoperative peritoneal biopsyProcedure or surgery
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
| Study group | Role | What they receive |
|---|---|---|
| COX-2 inhibitor (Celecoxib) | Active comparator | Celebrex; COX-2 inhibitor Receives: Drug: COX-2 inhibitor; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy |
| Placebo drug (Ramnos) | Placebo comparator | Ramnos; Lactobacillus casei variety rhamnosus Receives: Drug: Placebo Oral Tablet; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)
Secondary outcomes (4)
Visual analogue scale(VAS) score
Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)
Measured: every six hours for 48 hours
Numbers of rescue analgesia
Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)
Measured: From postoperation state to discharge (up to 2 days)
Postoperative complication
nausea, vomiting, etc.
Measured: From postoperation state to discharge (up to 2 days)
Duration of hospitalization
duration of hospitalization
Measured: From postoperation state to discharge (up to 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start17 Oct 2017
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Genital DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391570
- Sponsor's protocol ID
- 2017-1477
- Acronym
- COX2RCT
- Status last verified
- Dec 2017
- First submitted
- 24 Oct 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40722854
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03391570
- Acronym / sponsor ID
- COX2RCT / 2017-1477
- Conditions
- Female Genital Disease
- Keywords
- Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COX-2 inhibitor (Celecoxib) | Active comparator | Drug: COX-2 inhibitor, Procedure: Preoperative peritoneal biopsy, Procedure: Single-port laparoscopic surgery, Procedure: Postoperative peritoneal biopsyCelebrex; COX-2 inhibitor |
| Placebo drug (Ramnos) | Placebo comparator | Drug: Placebo Oral Tablet, Procedure: Preoperative peritoneal biopsy, Procedure: Single-port laparoscopic surgery, Procedure: Postoperative peritoneal biopsyRamnos; Lactobacillus casei variety rhamnosus |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female, Age ≥ 20 years
- Patients with benign female genital disease who need laparoscopic surgery
- Patients with benign disease who can be treated by single port laparoscopy
- Patients who signed an approved informed consent
Key exclusion criteria (8 listed)
- Female, Age < 20 years
- Pregnancy
- Previous cancer history
- Patients who refuse to sign an informed consent
- Patients with benign female genital disease combined clinical peritonitis (ex. tubo-ovarian abscess, tubo-ovaritis, ruptured endometriosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COX-2 inhibitorCelebrex 200mg/1cap 2 tablets, take medication an hour before surgery | Drug | COX-2 inhibitor (Celecoxib) |
| Placebo Oral TabletRamnos 250mg/1cap 2 tablets, take medication an hour before surgery | Drug | Placebo drug (Ramnos) |
| Preoperative peritoneal biopsyPreoperative peritoneal biopsy (1x1cm sized peritoneal tissue) | Procedure or surgery | COX-2 inhibitor (Celecoxib), Placebo drug (Ramnos) |
| Single-port laparoscopic surgerySingle-port laparoscopic surgery with CO2 gas | Procedure or surgery | COX-2 inhibitor (Celecoxib), Placebo drug (Ramnos) |
| Postoperative peritoneal biopsyPostoperative peritoneal biopsy (1x1cm sized peritoneal tissue) | Procedure or surgery | COX-2 inhibitor (Celecoxib), Placebo drug (Ramnos) |
Primary outcome
Change of biomarkers expression according to exposure to CO2 gas
Time frame: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)
Peritoneal biopsy and real-time polymerase chain reaction(RT-PCR), Immunohistochemistry of Biomarkers (COX-2, PGE2, PGF2, PGI2, TXA2)
4 secondary outcomes
Visual analogue scale(VAS) score
Time frame: every six hours for 48 hours
Numbers of rescue analgesia
Time frame: From postoperation state to discharge (up to 2 days)
Postoperative complication
Time frame: From postoperation state to discharge (up to 2 days)
Duration of hospitalization
Time frame: From postoperation state to discharge (up to 2 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 40722854Han 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Seung Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COX-2 inhibitor, Preoperative peritoneal biopsy and Single-port laparoscopic surgery in people with Female Genital Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Seung Kim, PhD (82-2-2072-4863, bboddi0311@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of biomarkers expression according to exposure to CO2 gas (time frame: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03391570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.