Female Genital Disease
Conditions
Keywords
Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid
Brief 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.
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
Interventions
DRUGCOX-2 inhibitor
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)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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 informed consent
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of biomarkers expression according to exposure to CO2 gas | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale(VAS) score | every six hours for 48 hours | Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10) |
| Numbers of rescue analgesia | From postoperation state to discharge (up to 2 days) | Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg) |
| Postoperative complication | From postoperation state to discharge (up to 2 days) | nausea, vomiting, etc. |
| Duration of hospitalization | From postoperation state to discharge (up to 2 days) | duration of hospitalization |
Countries
South Korea
Contacts
Primary ContactHee Seung Kim, PhD
Outcome results
None listed