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A randomized double‐blind controlled trial of different filling pressures in operative outpatient hysteroscopy
Author(s) -
Haggag Hisham,
Hassan AbdelGany,
Wahba Amr,
Joukhadar Ralf
Publication year - 2017
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1002/ijgo.12247
Subject(s) - medicine , hysteroscopy , randomization , randomized controlled trial , polypectomy , surgery , outpatient procedure , outpatient clinic , anesthesia , colonoscopy , colorectal cancer , cancer
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 NCT 02142673.