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

Primary Purpose

Female Genital Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
COX-2 inhibitor
Placebo Oral Tablet
Preoperative peritoneal biopsy
Single-port laparoscopic surgery
Postoperative peritoneal biopsy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Genital Disease focused on measuring Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

COX-2 inhibitor (Celecoxib)

Placebo drug (Ramnos)

Arm Description

Celebrex; COX-2 inhibitor

Ramnos; Lactobacillus casei variety rhamnosus

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Visual analogue scale(VAS) score
Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)
Numbers of rescue analgesia
Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)
Postoperative complication
nausea, vomiting, etc.
Duration of hospitalization
duration of hospitalization

Full Information

First Posted
October 24, 2017
Last Updated
December 30, 2017
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03391570
Brief Title
Comparing Postoperative Pain Following COX-2 and Prostanoids Expression
Acronym
COX2RCT
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Genital Disease
Keywords
Laparoscopic surgery, COX-2 inhibitor, Celecoxib, Prostanoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COX-2 inhibitor (Celecoxib)
Arm Type
Active Comparator
Arm Description
Celebrex; COX-2 inhibitor
Arm Title
Placebo drug (Ramnos)
Arm Type
Placebo Comparator
Arm Description
Ramnos; Lactobacillus casei variety rhamnosus
Intervention Type
Drug
Intervention Name(s)
COX-2 inhibitor
Intervention Description
Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery
Intervention Type
Procedure
Intervention Name(s)
Preoperative peritoneal biopsy
Intervention Description
Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
Intervention Type
Procedure
Intervention Name(s)
Single-port laparoscopic surgery
Intervention Description
Single-port laparoscopic surgery with CO2 gas
Intervention Type
Procedure
Intervention Name(s)
Postoperative peritoneal biopsy
Intervention Description
Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
Primary Outcome Measure Information:
Title
Change of biomarkers expression according to exposure to CO2 gas
Description
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 Outcome Measure Information:
Title
Visual analogue scale(VAS) score
Description
Degree of postoperative pain (No pain : 0 / Moderate pain : 5 / Unbearable pain : 10)
Time Frame
every six hours for 48 hours
Title
Numbers of rescue analgesia
Description
Frequency of additional pain killer (Tramadol 50mg, Ketorolac 2mg/kg)
Time Frame
From postoperation state to discharge (up to 2 days)
Title
Postoperative complication
Description
nausea, vomiting, etc.
Time Frame
From postoperation state to discharge (up to 2 days)
Title
Duration of hospitalization
Description
duration of hospitalization
Time Frame
From postoperation state to discharge (up to 2 days)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Seung Kim, PhD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunji Lee, MD
Phone
82-2-2072-2643
Email
bliss8880103@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, PhD
Phone
82-2-2072-4863
Email
bboddi0311@gmail.com
First Name & Middle Initial & Last Name & Degree
Hee Seung Kim, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing Postoperative Pain Following COX-2 and Prostanoids Expression

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