Trendelenburg, Abdominal Insufflation and Time to Completion of Cystoscopy A Prospective Randomized Trial
Phase: NA
Conditions: Bladder Integrity, Bladder Function, Ureteral Integrity, Ureteral Function
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Trendelenburg, abdominal insufflation and time to completion of cystoscopy. A 
prospective randomized trial. 
 
NCT05786391 
 
Version Date: 02/28/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
Protocol Title: Trendelenburg, abdominal insufflation and time to completion of 
cystoscopy. A prospective randomized trial. 
 
Principal investigator: Randa Jalloul, MD (Gynecology Faculty) 
 
Statistician: Claudia Pedroza 
 
Study coordinator: Sunbola Ashimi, PhD 
 
Population: 136 female patients undergoing a planned cystoscopy after Minimally 
Invasive Gynecological procedure. 
 
Number of sites: Two sites MHH-TMC and LBJ. 
 
Study duration: 2 years 
 
Subject duration: 6 weeks 
 
 
General Information (PICO) 
This is a randomized controlled trial assessing time to completion of cystoscopy in 
seconds after minimally invasive gynecologic surgery 
We seek to compare the efficiency of the cystoscopy with two interventions: 
after 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 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. 
Our main objective is to assess which intervention or combination of interventions is 
more efficient. 
 
Background 
 
Iatrogenic injury to the genitourinary tract is a rare, but significant cause of morbidity in 
patients undergoing gynecologic surgery for benign indications.1–3 
In 2012, the American Association of Gynecologic Laparoscopists recommended that 
routine cystoscopy be performed after all laparoscopic hysterectomies, whereas the 
American College of Obstetricians and Gynecologists limited the endorsement to 
prolapse and incontinence procedures.4,5 Universal cystoscopy, where all women 
undergoing hysterectomy undergo cystoscopy, has been advocated because as many 
as 75% of genitourinary injuries occur in women without identifiable risk 
factors. 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
In one large study, cystoscopy was associated with a median increase in operative time 
of 17 minutes6. Increases in operative time and cost are the most commonly cited 
concerns regarding cystoscopy with recent estimates of operating room time, not 
including surgeon and anesthesiologist fees, at $37 per minute,7 cystoscopy results in 
an additional $629 per hysterectomy in operating room time alone. 
 
When performing gynecologic laparoscopy, the patient is in a Trendelenburg position 
(Head down) and the abdomen is normally insufflated to 15 mm Hg during the entire 
surgery that can take up to 4 hours. 
Cystoscopy is done at the end to assure integrity of the bladder and ureteral function, 
Some surgeons like to do it with the patient in the Trendelenburg position and others 
flatten the patient position or insufflate the abdomen with the thought that it may reduce 
the time needed to complete the cystoscopy. 
 
Theoretically, one would predict that performing the cystoscopy under low intra- 
abdominal pressure (no CO2 insufflation) and flat (with the added effect of gravity), 
would save time in the operating room. 
In addition to those modifiable factors, additional factors may include fluid status (total 
urinary output during the surgery and fluid given intraoperatively as well as blood loss), 
duration of the surgery, manipulation of the ureters and the bladder (ureterolysis or 
bladder mobilization/presence of scar tissue) as well as blood loss overall. 
 
Hypothesis: 
 
Non Trendelenburg or flat position and Non insufflation of the abdomen significantly 
reduces cystoscopy procedure time after gynecologic laparoscopy. 
 
 
Objective: 
 
We seek to compare the efficiency of the cystoscopy with two interventions: 
after two interventions: 
1- patient position during the cystoscopy (Trendelenburg (head down) or flat) 
2- Abdominal insufflation (insufflation versus no insufflation). 
 
Population 
All patients undergoing minimally invasive gynecologic surgery with planned cystoscopy 
to evaluate urinary tract injury at two main sites: LBJ and MHH-TMC 
 
Inclusion: 
Patient undergoing Planned cystoscopy in the benign gynecology service. 
 
Exclusion: 
Pregnancy 
Known urologic anomaly 
Unplanned cystoscopy 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
Cancer surgery 
Urogynecology surgery 
Patient with comorbidities including cardiac disease, chronic hypertension, any stage 
kidney disease (including abnormal creatinine level) and use of diuretics. 
Patients undergoing extensive ureterolysis 
Blood loss more than 500 mls 
Contra-indications to position change and insufflation 
 
 
Study design: 
Prospective randomized controlled study 2X2 bloc randomized based on position status 
and Patient position as the two interventions being evaluated: 
1. Patient Position: flat versus Trendelenburg 
2. Insufflation status: Yes versus no insufflation, 
 
Outcomes: 
Primary outcome: Time in seconds to satisfactorily complete a cystourethroscopy 
(visualize the dome, the ureteral jets, the bladder mucosa scan and the urethra). 
 
With additional detail in recording time as follows 
T0: Start of cystoscopy 
T1: time to see one of the ureteral jets 
T2 as the second ureteral jet 
T3: completion of cystoscopy 
 
Exploratory outcome: 
Surgeon satisfaction with the interventions (Likert scale questionnaire): The surgeon 
completes 6 Likert scale questions: 
 
1- Global satisfaction (I will use this method routinely; it satisfies my requirements 
for cystoscopy). 
 
Randomization 
The randomization scheme is maintained by Redcap electronically at the time of 
consent. 
Patients are randomized to 1 of 4 groups based on position and insufflation status 
1- Position flat, No insufflation, 
2- Position Trendelenburg, insufflation to 15 mm Hg 
3- Position Flat, insufflation 
4- Position Trendelenburg, No insufflation 
 
Randomization occurs in preOp prior to rolling to the operating room. 
Neither the surgeons nor the operating room team are blinded to the study group as it 
required changing position and insufflation. 
Cystoscopy medium is sterile water. 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
Randomization will be performed by the research team (the research fellow who is part 
of the research team). 
It will be performed via redcap using the permutated block method, with an allocation 
ratio of 1:1:1:1. Patients are blinded to what group they are randomized to. 
 
 
If cystoscopy is not completed and additional dye is necessary for visualization (as 
would normally occur outside the setting of the study), then, subjects will be treated as 
per routine and receive sodium fluorescein (25 mg intravenous sodium fluorescein 
(concentration 500 mg in 5 mL). 
 
Time will be recorded by the circulating nurse via a stopwatch. 
 
Study duration: 
Study duration will be for 6 weeks to allow to review the chart for postoperative 
outcomes, see variable list to be collected. 
 
Adverse events: 
None anticipated outside the routine procedure of cystoscopy. 
Cystoscopy risks include possible urinary tract infection. Participation in the study does 
not increase the risk, as cystoscopy is planned. 
There are no additional risks involved with this study beyond the risks discussed at the 
time of surgical consent. Both position changes (Trendelenberg) and insufflation are 
part of the laparoscopic procedure. This means that if a patient has a contra-indication 
to any intervention, she will not be undergoing the procedure. The cystoscopy portion of 
the procedure is expected to take minutes, in comparison to the procedure, which will 
take hours. Risks of insufflation and position changes include hemodynamic and 
respiratory changes that are closely monitored by the anesthesia and the surgical team. 
We have included this in the consent form. 
 
 
Data: 
Demographic characteristics are abstracted from chart review by study personnel. 
Characteristics included age, BMI, parity, race/ethnicity, indication for surgery, and 
medical history. Intervention and surgical data are collected, including type of surgery, 
surgical start and stop times, cystoscopy start and stop times, estimated blood loss, and 
whether furosemide or an intravenous fluid bolus was given to assist with assessment 
of ureteral jets. 
Cystoscopy is performed using a 21F sheath and a 70-degree cystoscope. Per protocol, 
after determining the 12 o’clock position at the bladder dome via the air bubble, the 
ureteral jets were visualized until surgeon’s confidence in the patency of the ureters was 
determined. Subsequently, a systematic global survey was performed of the bladder, 
followed by examination of the urethra as the cystoscope was withdrawn. 
 
There are no anticipated adverse events for the two interventions evaluated, as the 
patient position and insufflation are two variables that routinely occur during surgery. 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
 
At the conclusion of the study (when the final randomized patient met the 6-week 
postoperative mark), all patient medical records will be reviewed for operative data 
including operative complications. 
 
 
Statistical analysis 
Continuous variables are described with mean (SD) or median (range) depending on 
the distribution of the data. Statistical tests for continuous data were based on 1-way 
analysis of variance for normally distributed data, or the Kruskal-Wallis test for 
nonnormal data. This is determined by histogram plots and Levene test. Categorical 
variables are described with numbers (percentages) and compared using the χ2 test. All 
statistical tests were 2-tailed, and were based on the intent-to-treat principle. 
 
Sample size analysis 
Median and IQR cystoscopy duration is 168 (86-286) seconds8, a clinically significant 
improvement in cystoscopy times would be 108 (69-160). 
 
 
Insufflation - 
Insufflation + 
Flat 
Group1 
Group2 
T-Berg 
Group3 
Group4 
 
Using analysis of variance, 28 subjects in each arm for a total of 112 subjects would be 
needed to detect an effect size of > 60 seconds, with 80% power and a 2-tailed alpha of 
0.05 to achieve statistical significance using the frequentist method. To account for 20% 
drop outs, we will include 34 patients in each group for a total of 136 cystoscopy 
procedures, 
 
The one minute decrease in operative time is used based on prior studies showing that 
the use of “Lasix” intraoperatively can significantly reduce cystoscopy duration by about 
78 seconds.8 
 
• 
CONSORT diagram will be performed 
• 
We will evaluate for the presence of interaction between the different 
interventions as two interventions are employed at the same time. 
• 
Intention to treat analysis will be performed 
• 
All unadjusted outcomes will be reported descriptively (mean SD/ median IQR) 
• 
For all outcomes, we will conduct intent-to-treat Bayesian analysis to calculate 
probabilities of intervention benefits and harms. We will use neutral priors and 
exclude large treatment effects. We will report posterior medians of group 
differences, their corresponding 95% credible intervals, and probability of 
treatment benefit. 
Funding: 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
None 
 
OVERSIGHT RESPONSIBILITIES 
Oversight of the trial is provided by the Principal Investigator (PI), Dr. Randa Jalloul and 
Co-investigators Drs Mateo Leon and Aya Mohr-Sasson. 
 
 
Ethics 
− IRB approval will be sought for this study, and admin Approval sought from Harris 
Health and MHH approval as well as a departmental review. 
− We are asking to obtain verbal consent for patients to participate. Position and 
insufflation are two interventions done routinely and changed by the surgeon many 
times during different parts of the surgery. 
− Patient protected information is coded and protected using the Redcap software and 
destroyed once the study is published. 
− The study is conducted in accordance with the Consolidated Standards of Reporting 
Trials (CONSORT) statement, the Helsinki Declaration, and monitored by the Good 
Clinical Practice Unit 
− Will register the trial once the IRB is approved. 
 
Data handling and record keeping 
− There will be a linking log maintained 
 
Publication Plan 
− Plan to publish in the JMIG 
− Results are not returned to subjects 
 
References: 
 
1. Dowling RA, Corriere JN Jr, Sandler CM. Iatrogenic ureteral 
injury. J Urol 1986;135:912–5. 
2. Ozdemir E, Ozturk U, Celen S, et al. Urinary complications of 
gynecologic surgery: iatrogenic urinary tract system injuries in 
obstetrics and gynecology operations. Clin Exp Obstet Gynecol 
2011;38:217–20. 
3. Sawkar HP, Kim DY, Thum DJ, et al. Frequency of lower 
urinary tract injury after gastrointestinal surgery in the nationwide 
inpatient sample database. Am Surg 2014;80:1216–21. 
4. The role of cystourethroscopy in the generalist obstetriciangynecologist 
practice. ACOG Committee Opinion No. 372. 
American College of Obstetricians and Gynecologists. Obstet 
Gynecol 2007;110:221–4. 
5. AAGL Advancing Minimally Invasive Gynecology Worldwide. 
AAGL practice report: practice guidelines for intraoperative 
cystoscopy in laparoscopic hysterectomy. J Minim 

IRB NUMBER: HSC-MS-22-1081 
IRB APPROVAL DATE: 02/28/2023 
 
Invasive Gynecol 2012;19:407–11. 
6. Barber, E. , Polan, R. , Strohl, A. , Siedhoff, M. & Clarke-Pearson, 
D. (2019). Cystoscopy at the Time of Hysterectomy for Benign Indications and Delayed 
Lower Genitourinary Tract Injury. Obstetrics & Gynecology, 133 (5), 888-895. 
7. Childers CP, Maggard-Gibbons M. Understanding costs of care 
in the operating room. JAMA Surg 2018;153:e176233. 
8. Patton S, Tanner JP, Prieto I, Jackson E, Greene K, Bassaly R, Wyman AM. 
Furosemide Use and Time to Confirmation of Ureteral Patency During Intraoperative 
Cystoscopy: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):669- 
674.