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A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy
Hisham Haggag1,2, AbdelGany Hassan1, Amr Wahba1
1Department of Obstetrics and Gynaecology, Faculty of Medicine, Cairo University, Cairo, Egypt.
Objective:
To identify the optimal filling pressure during operative outpatient hysteroscopy that allows completion of the procedure while minimizing pain.
Methods:
A double-blind randomized controlled trial of women aged 20-60 years undergoing operative hysteroscopy (including biopsy sampling, polypectomy, septum excision, adhesiolysis, or intrauterine device removal) was undertaken at a university hospital in Egypt between May 2014 and July 2016. Using a computer-generated randomization sequence, patients were randomly assigned into three equal groups: filling pressures of 40 mm Hg (group 1), 60 mm Hg (group 2), and 80 mm Hg (group 3; control). The primary outcome was the proportion of successfully completed procedures. Analyses were by intention to treat.
Results:
Each group contained 80 women. The procedure was completed for 63 (79%) women in group 1, 73 (91%) in group 2, and 76 (95%) in group 3 (P=0.004). The proportion of completed procedures in group 3 was significantly different from that in group 1 (P=0.002), but did not differ significantly from that in group 2 (P=0.349).
Conclusion:
A uterine filling pressure of 60 mm Hg does not reduce the frequency of completion when compared with 80 mm Hg in operative outpatient hysteroscopy. CLINICALTRIALS.
Gov Registration:
NCT02142673.
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