Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

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

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)

Study Overview

• Status: Recruiting
• Conditions: Bladder Function; Bladder Integrity; Ureteral Integrity; Ureteral Function
• Intervention / Treatment: Other: Flat position; Other: Trendelenburg position; Device: Insufflation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunbola Ashimi, PhD; Phone Number: 713-500-6410; Email: sunbola.s.ashimi@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Sunbola Ashimi, PhD; Phone Number: 713-500-6410; Email: sunbola.s.ashimi@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flat position with no Insufflation	Other: Flat position; Flat patient position during the cystoscopy
Experimental: Trendelenburg position and Insufflation; insufflation to 15 mm Hg	Other: Trendelenburg position; Trendelenburg position (head down) during the cystoscopy; Device: Insufflation; Insufflation to 15 mm Hg
Experimental: Flat position and Insufflation	Other: Flat position; Flat patient position during the cystoscopy; Device: Insufflation; Insufflation to 15 mm Hg
Experimental: Trendelenburg position with no Insufflation	Other: Trendelenburg position; Trendelenburg position (head down) during the cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Randa Jalloul, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-22-1081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No