Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

The University of Texas System (UT)

Status: Completed

Conditions: Ureteral Integrity; Bladder Integrity; Ureteral Function; Bladder Function

Treatments: Device: Insufflation; Other: Trendelenburg position; Other: Flat position

Study type: Interventional

Funder types: Other

Identifiers

NCT05786391

HSC-MS-22-1081

Details and patient eligibility

About

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)

Full 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.

Enrollment: 122 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 4 patient groups

Flat position with no Insufflation

Experimental group

Treatment:

Other: Flat position

Trendelenburg position and Insufflation

Experimental group

Description:

insufflation to 15 mm Hg

Treatment:

Other: Trendelenburg position

Device: Insufflation

Flat position and Insufflation

Experimental group

Treatment:

Other: Flat position

Device: Insufflation

Trendelenburg position with no Insufflation

Experimental group

Treatment:

Other: Trendelenburg position