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OpenTrials
Completed

NCT Number: NCT05786391

Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Objective:

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)

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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:

  • patient position during the cystoscopy (Trendelenburg (head down) or flat)
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Time in Seconds to Complete the Cystourethroscopy

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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