The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.
The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study. Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days. Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
250 mg oral three times a day for 14 days
Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days
University of Louisville Hospital
Louisville, Kentucky, United States
Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time frame: 6 weeks postoperatively.
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time frame: 1 year postoperatively.
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time frame: 6 months postoperatively.
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time frame: 6 weeks postoperatively.
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time frame: 5 years postoperatively.
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time frame: 6 weeks postoperatively.
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time frame: 6 months postoperatively.
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
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Time frame: 1 year postoperatively.
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time frame: 5 year postoperatively.
Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time frame: 1 year postoperatively.
Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time frame: 6 months postoperatively.