Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

This is a randomized controlled trial assessing time to completion of cystoscopy in seconds after minimally invasive gynecologic surgery.

The investigators seek to compare the efficiency of the cystoscopy with two interventions:

1. patient position during the cystoscopy (Trendelenburg (head down) or flat)
2. Abdominal insufflation (insufflation versus no insufflation).

Both interventions are used as usual care and depend on surgeon preference without evidence why one would be faster at completing the cystoscopy. Also note that these two interventions are performed multiple times during the surgery itself and outside the cystoscopy procedure routinely. The investigator's main objective is to assess which intervention or combination of interventions is more efficient.

• Flat position (Other): Flat patient position during the cystoscopy
• Trendelenburg position (Other): Trendelenburg position (head down) during the cystoscopy
• Insufflation (Device): Insufflation to 15 mm Hg

Primary outcomes

• Time in Seconds to Complete the Cystourethroscopy [From the start of the cystoscopy to the completion of the cystoscopy (about 4 minutes)]: Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).

Sex: Female, ages: 18 Years to 90 Years, accepts healthy volunteers

Inclusion Criteria:

\- Patient undergoing Planned cystoscopy in the benign gynecology service, (specifically undergoing a laparoscopic or robotic procedure requiring insufflation).

Exclusion Criteria:

* Pregnancy
* Known urologic anomaly
* Unplanned cystoscopy
* Cancer surgery
* Urogynecology surgery
* comorbidities including cardiac disease, chronic hypertension, any stage kidney disease (including abnormal creatinine level), and use of diuretics.
* Undergoing extensive ureterolysis
* Blood loss more than 500 milliliters (mLs)
* Contra-indications to position change and insufflation

Participant flow

Outcome results

• Time in Seconds to Complete the Cystourethroscopy (Primary), Median, seconds: Flat Position With no Insufflation 103 (65 to 184); Trendelenburg Position and Insufflation 117 (50 to 223); Flat Position and Insufflation 147 (71 to 208); Trendelenburg Position With no Insufflation 82 (71 to 136)

Adverse events

Time frame: 6 weeks

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2023-02-28)

• Randa Jalloul, MD, Principal investigator, The University of Texas Health Science Center, Houston