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

Int J Gynaecol Obstet. 2017 Oct;139(1):55-60. doi: 10.1002/ijgo.12247. Epub 2017 Jul 25.

Abstract

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.

Keywords: Filling pressure; Hysteroscopy; Operative outpatient hysteroscopy; Pain.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Ambulatory Care
  • Double-Blind Method
  • Egypt
  • Female
  • Hospitals, University
  • Humans
  • Hysteroscopy / methods*
  • Insufflation / methods*
  • Middle Aged
  • Pain / prevention & control
  • Pain Measurement
  • Pressure
  • Treatment Outcome
  • Uterus / physiopathology*
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT02142673