Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy

NCT ID: NCT05786391

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-02-05

Brief 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)

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.

Conditions

Bladder Integrity; Bladder Function; Ureteral Integrity; Ureteral Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Flat position with no Insufflation

Group Type: EXPERIMENTAL

Flat position

Intervention Type: OTHER

Flat patient position during the cystoscopy

Trendelenburg position and Insufflation

insufflation to 15 mm Hg

Group Type: EXPERIMENTAL

Trendelenburg position

Intervention Type: OTHER

Trendelenburg position (head down) during the cystoscopy

Insufflation

Intervention Type: DEVICE

Insufflation to 15 mm Hg

Flat position and Insufflation

Group Type: EXPERIMENTAL

Flat position

Intervention Type: OTHER

Flat patient position during the cystoscopy

Insufflation

Intervention Type: DEVICE

Insufflation to 15 mm Hg

Trendelenburg position with no Insufflation

Group Type: EXPERIMENTAL

Trendelenburg position

Intervention Type: OTHER

Trendelenburg position (head down) during the cystoscopy

Interventions

Flat position

Flat patient position during the cystoscopy

Intervention Type: OTHER

Trendelenburg position

Trendelenburg position (head down) during the cystoscopy

Intervention Type: OTHER

Insufflation

Insufflation to 15 mm Hg

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Randa Jalloul

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randa Jalloul, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-22-1081

Identifier Type: -

Identifier Source: org_study_id