A randomized double-blind controlled trial of different filling pressures in operative outpatient hysteroscopy.

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.