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Trial record 3 of 1590 for:    Recruiting, Not yet recruiting, Available Studies | "Genital Diseases, Female"

Comparing Postoperative Pain Following COX-2 and Prostanoids Expression (COX2RCT)

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ClinicalTrials.gov Identifier: NCT03391570
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hee Seung Kim, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Female Genital Disease Drug: COX-2 inhibitor Drug: Placebo Oral Tablet Procedure: Preoperative peritoneal biopsy Procedure: Single-port laparoscopic surgery Procedure: Postoperative peritoneal biopsy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: COX-2 inhibitor (Celecoxib)
Celebrex; COX-2 inhibitor
Drug: COX-2 inhibitor
Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery

Procedure: Preoperative peritoneal biopsy
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Procedure: Single-port laparoscopic surgery
Single-port laparoscopic surgery with CO2 gas

Procedure: Postoperative peritoneal biopsy
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Placebo Comparator: Placebo drug (Ramnos)
Ramnos; Lactobacillus casei variety rhamnosus
Drug: Placebo Oral Tablet
Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery

Procedure: Preoperative peritoneal biopsy
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)

Procedure: Single-port laparoscopic surgery
Single-port laparoscopic surgery with CO2 gas

Procedure: Postoperative peritoneal biopsy
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Visual analogue scale(VAS) score [ Time Frame: every six hours for 48 hours ]
    Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)

  2. Numbers of rescue analgesia [ Time Frame: From postoperation state to discharge (up to 2 days) ]
    Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)

  3. Postoperative complication [ Time Frame: From postoperation state to discharge (up to 2 days) ]
    nausea, vomiting, etc.

  4. Duration of hospitalization [ Time Frame: From postoperation state to discharge (up to 2 days) ]
    duration of hospitalization



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391570


Contacts
Contact: Hee Seung Kim, PhD 82-2-2072-4863 bboddi0311@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eunji Lee, MD    82-2-2072-2643    bliss8880103@gmail.com   
Contact: Hee Seung Kim, PhD    82-2-2072-4863    bboddi0311@gmail.com   
Principal Investigator: Hee Seung Kim, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hee Seung Kim, PhD Seoul National University Hospital

Responsible Party: Hee Seung Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03391570     History of Changes
Other Study ID Numbers: 2017-1477
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hee Seung Kim, Seoul National University Hospital:
Laparoscopic surgery
COX-2 inhibitor
Celecoxib
Prostanoid

Additional relevant MeSH terms:
Genital Diseases, Female
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents