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

Seoul National University

Status: Unknown

Conditions: Female Genital Disease

Treatments: Drug: COX-2 inhibitor; Drug: Placebo Oral Tablet; Procedure: Preoperative peritoneal biopsy; Procedure: Single-port laparoscopic surgery; Procedure: Postoperative peritoneal biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03391570

2017-1477

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

COX-2 inhibitor (Celecoxib)

Active Comparator group

Description:

Celebrex; COX-2 inhibitor

Treatment:

Procedure: Preoperative peritoneal biopsy

Procedure: Single-port laparoscopic surgery

Procedure: Postoperative peritoneal biopsy

Drug: COX-2 inhibitor

Placebo drug (Ramnos)

Placebo Comparator group

Description:

Ramnos; Lactobacillus casei variety rhamnosus

Treatment:

Procedure: Preoperative peritoneal biopsy

Procedure: Single-port laparoscopic surgery

Procedure: Postoperative peritoneal biopsy

Drug: Placebo Oral Tablet