Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786391

Collaborator

(none)

136

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective:

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)

Condition or Disease	Intervention/Treatment	Phase
Bladder Integrity Bladder Function Ureteral Integrity Ureteral Function	Other: Flat position Other: Trendelenburg position Device: Insufflation	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2023

Anticipated Primary Completion Date :

Mar 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Time in seconds to complete the cystourethroscopy [From the start of the cystoscopy to the completion of the cystoscopy (about 17 minutes)]
Time in seconds to satisfactorily complete the cystourethroscopy (including visualization of the dome, the ureteral jets, the bladder mucosa, and the urethra).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Randa Jalloul, Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT05786391

Other Study ID Numbers:

HSC-MS-22-1081

First Posted:

Mar 27, 2023

Last Update Posted:

Mar 27, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Mar 27, 2023