Myoma;Uterus Clinical Trial
Official title:
Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions
The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions.
In the cycle subsequent to hysteroscopic identification of an endouteine pathology, patients
who fitted with the inclusion criteria will be randomly divided into two groups; letrozole
group (study group) and placebo group (control group). The randomization will be a stratified
randomization with permuted blocking (the block size is randomly permuted among 2, 4, and 6)
within each stratum. The only stratification variable will be by type of endouterine
pathology. The randomization will be balanced (using a 1:1 treatment ratio) and will be
carried out by a nurse through sealed, unlabeled, opaque envelopes containing
computer-generated random numbers. The study will be double-blind (the participants,
caregivers and investigators will be blinded to block size and group assignment).
Women in the letrozole group will be treated with letrozole (5 mg daily) for 10 days before
hysteroscopic intervention while women in the placebo group will be treated with placebo for
10 days before hysteroscopic intervention in the early follicular phase of a natural cycle.
In both groups, monopolar hysteroscopic surgery with glycine (1.5%) as uterine distension
media will be used. Precise records of the duration of each surgical procedure, from the
insertion to the removal of the resectoscope will be done.
Measurements of inflow, outflow, and amount of distension liquid absorbed by the patient will
be taken meticulously. Intraoperative bleeding will be defined as "light" when bleeding does
not interfere with surgery, "moderate" when bleeding required the coagulation of vessels, and
"severe" when hemorrhage required immediate suspension of hysteroscopy. At the end of
surgery, surgeon satisfaction with endometrial preparation using Visual Analogue Scale (VAS)
and quality of visualization of the uterine cavity will be compared. Postoperative
complications will be defined as the appearance of any complications occurring from the
termination of the surgery to discharge.
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