Comparison of the effect of aspirin and placebo on pelvic pain and the number and size of endometriosis lesions after surgery

Comparison of the effect of aspirin and placebo on pelvic pain and the number and size of endometriosis lesions after surgery

This study is designed as a randomized, triple-blind clinical trial with parallel groups with a sample size of 61 individuals per group.

This study will be done on 122 women with endometriosis undergoing surgery. After random allocation, they will be treated with OCP and placebo or OCP and aspirin daily for 6 months. Pelvic pain, dysmenorrhea, mass size, and menstrual bleeding will be evaluated after 3 and 6 months.

Inclusion criteria:Patients with endometriosis undergoing surgery, 18-40 years old Exclusion criteria: All people who have contraindications to taking OCPs and aspirin (platelet disorders, bleeding disorders, gastrointestinal bleeding, severe dehydration, liver failure), pregnancy, Willing to become pregnant, Malignancy

Control group: Intervention group: OCP and placebo daily for 6 months Intervention group: OCP and Asprin 80 mg daily for 6 months

Pelvic pain,Dysmenorrhea, Dyspareunia,Menstrual bleeding, The size and the number of masses

Our sample size is 122 people, with 61 people in each group. Block randomization method was designed by epidemiologist using STATA version 13 software. The number of participants in each block is 4.

At the present study, we will use a placebo that is completely similar to aspirin, so that the physician and the patient will not be aware of the type of the intervention. Also, the person evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. A statistician who is unaware of the type of interventions in each group will analyse the data. So, participants, the person evaluating the outcome, the physician and the analyzer, are all blind.