Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
Condition: Uterine Fibroids; Vaginal Bleeding
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study will look at the optimal order in which to perform concurrent office hysteroscopy
      and endometrial biopsy in female patients who present for evaluation of abnormal uterine
      bleeding at a fibroid and endometriosis treatment center.
    

Detailed description: 
      This will be a prospective single blinded randomized control trial to determine whether the
      order of performance of office hysteroscopy (OH) and endometrial biopsy (EMB) during the same
      office evaluation for abnormal uterine bleeding affects the patient's pain perception. We
      also intend to investigate whether the order of the procedures affects the adequacy of the
      endometrial sample, duration of the procedure, and optimal visualization of the uterine
      cavity. We hypothesize that performing EMB prior to OH will result in higher patient pain
      scores.

      Included patients will be all consecutive female patients ages 18-70 presenting to the
      University of South Florida Center for Endometriosis and Fibroid Treatment (CFERT) for
      evaluation of abnormal uterine bleeding or uterine fibroids.

      Patients will be randomly assigned to have either OH followed by EMB or EMB followed by OH as
      part of their clinical assessment of AUB/uterine fibroid based on clinical indication. The
      patients will be informed about the two indicated procedures by their clinical provider but
      will be blinded to the order of performance. The healthcare provider/investigator will be
      aware of the order in which the procedures are assigned and to be performed. Patients will be
      consented to participate in the study prior to the procedure by the study team on the day the
      indicated procedures are scheduled in CFERT. The healthcare provider performing the procedure
      will open an unlabeled envelope, within which there will be a piece of paper indicating which
      procedure is to be performed first. This will then be recorded in the study log. The study
      log will include enrolled patients, assigned study number which will range from 001 to the
      minimum number of patients required for the study as indicated by sample size calculation.

      At the end of the procedures, patient will be asked to describe their pain perception based
      on Visual analogue scale (VAS) from 0-10. The adequacy of the endometrial sample will be
      determined from the pathology report. The duration of the entire procedures (min) will be
      timed using a stopwatch from the time of insertion of the hysteroscope/Pipelle catheter in
      the external cervical canal to removal of the instruments. A panoramic picture of the
      endometrial cavity will be taken and will be given to a blinded independent reviewer to
      determine the adequacy of visualization based on 3 point scoring system (fair, good and
      excellent). Fair visualization will be defined as no tubal ostia visualized; good will be
      defined as both tubal ostia identified but only able to visualize 180 degrees of panorama;
      excellent visualization will be defined as visualizing bilateral tubal ostia and having a
      clear image of the uterine cavity in 360 degrees of panorama.
    

Intervention name(s): Office hysteroscopy; Endometrial biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.; An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Office hysteroscopy; Endometrial biopsy; Abnormal uterine bleeding; Uterine fibroids