ClinicalTrials.gg
Status unknownNCT03391570COX2RCTUpdated Jan 5, 2018

Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

An interventional study of COX-2 inhibitor and Placebo Oral Tablet in Female Genital Disease, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 20 studies in Genital Diseases, Female with a site in Korea, Republic of — none open to participants now, none under way, none of them phase 3. Genital Diseases, Female · Korea, Republic of.

Planned enrollment
14th of 20
60 · median 79
Started
2017
the only one that year
No phase
14 of 20
none open now
Registered
12th of 20
by date
Lead sponsor
2 of 20
Seoul National University Hospital

Among the 20 studies in Genital Diseases, Female with a site in Korea, Republic of, this one is the 14th largest by planned enrollment, is the only one that started in 2017, is one of 14 with no phase, and was the 12th registered.

Genital Diseases, Female

161 studies on the registry are indexed under Genital Diseases, Female; 31 are open to participants now.

Browse Genital Diseases, Female studies →

Open to participants now

None of the 20 studies in Genital Diseases, Female with a site in Korea, Republic of is open now. The open studies under Genital Diseases, Female, anywhere →

Who these studies take

Of the 21 Genital Diseases, Female studies recruiting now, 10 (48%) set no upper age limit and 11 (52%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 20 Years and older · female · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 20 studies in Genital Diseases, Female with a site in Korea, Republic of as a file.
02

Study 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) 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

03

Conditions studied

  • Female Genital Disease

Keywords

  • Laparoscopic surgery
  • COX-2 inhibitor
  • Celecoxib
  • Prostanoid
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Female, Age \< 20 years
  • Pregnancy
  • Previous cancer history
  • Patients who refuse to sign an
  • 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 with COX-2 inhibitors (liver disease, renal disease, active peptic ulcer, active gastrointestinal tract bleeding, ischemic heart disease, hyperkalemia)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    COX-2 inhibitor (Celecoxib)

    Celebrex; COX-2 inhibitor

    Drug: COX-2 inhibitor · Procedure: Preoperative peritoneal biopsy · Procedure: Single-port laparoscopic surgery · Procedure: Postoperative peritoneal biopsy

  • Placebo comparator
    Placebo drug (Ramnos)

    Ramnos; Lactobacillus casei variety rhamnosus

    Drug: Placebo Oral Tablet · Procedure: Preoperative peritoneal biopsy · Procedure: Single-port laparoscopic surgery · Procedure: Postoperative peritoneal biopsy

Interventions

  • Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery

  • DrugPlacebo Oral Tablet

    Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery

  • ProcedurePreoperative peritoneal biopsy

    Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

  • ProcedureSingle-port laparoscopic surgery

    Single-port laparoscopic surgery with CO2 gas

  • ProcedurePostoperative peritoneal biopsy

    Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Peritoneal biopsy will be done twice (intraoperative, at right after trocar insertion and right before trocar removal, an average of 2-3hours)

Secondary outcomes

  1. Visual analogue scale(VAS) score

    Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)

    Time frame: every six hours for 48 hours

  2. Numbers of rescue analgesia

    Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)

    Time frame: From postoperation state to discharge (up to 2 days)

  3. Postoperative complication

    nausea, vomiting, etc.

    Time frame: From postoperation state to discharge (up to 2 days)

  4. Duration of hospitalization

    duration of hospitalization

    Time frame: From postoperation state to discharge (up to 2 days)

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Oct 2019, 24 months after the start.

Of 55 non-industry interventional studies with no phase under Genital Diseases, Female, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 24 months is above that.

Counting every sponsor, half of 65 studies reached it within 14 months; a quarter within 8 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2017
First posted
Jan 5, 2018
StartActual
Oct 17, 2017
Primary completionEst.
Oct 2019
CompletionEst.
Oct 2019
Last update
Jan 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391570
Responsible party
Hee Seung Kim (Associate Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 5, 2018
Start date
Oct 17, 2017
Primary completion
Oct 2019 (estimated)
Completion
Oct 2019 (estimated)
Last update
Jan 5, 2018

Study contacts

Hee Seung Kim, PhD
Contact
bboddi0311@gmail.com
82-2-2072-4863
Hee Seung Kim, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: COX-2 inhibitors

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