Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Bladder Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786391
• Other study ID #: HSC-MS-22-1081
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Sunbola Ashimi, PhD
• Phone: 713-500-6410
• Email: sunbola.s.ashimi[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: June 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Function

Intervention

Other:
• Flat position
Flat patient position during the cystoscopy
• Trendelenburg position
Trendelenburg position (head down) during the cystoscopy

Device:
• Insufflation
Insufflation to 15 mm Hg

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in seconds to complete the cystourethroscopy	Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).	From the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes)