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EXHIBIT R
FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015
NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020
ADULT UROLOGY . ,
CME ARTICLE
ELSEVIER
PROPHYLACTIC URETERAL CATHETERIZATION IN
GYNECOLOGIC SURGERY
KAZUNARI KUNO, ANDREW MENZIN, H. HUGH KAUDER, CRISTINA SISON, AND DAVID GAL
ABSTRACT
Objectives. To examine the frequency of ureteral catheter usage, its efficacy in preventing injury, and related
complications, because the preoperative routine placement of ureteral catheters as a prophylactic measure
to prevent ureteral injury is controversial.
Methods. All major gyilecclagic operations performed between January 1992 and December 1994 were
identified. All gynecologic procedures that were preceded iden-
by ureteral catheter placement were also
tified. A data base maintained by the Department of Quality Management allowed identification of all urinary
tract cGmplications and ureteral injuries. Four categories of surgery were analyzed: exploratory laparotomy
with catheters, exploratory laparotomy without catheters, operative laparoscopy with catheters, and oper-
ative laparoscopy without catheters. The medical records of all patients with urinary tract complications
were reviewed.
Results. Bilateral prophylactic ureteral catheterization was performed in 469 (15.3%) of 3071 patients. A
ureteral injury occurred in 4 (0.13%) of 3071 patients. All four ureteral injuries (0.17%) occurred among
2338 patients who underwent exploratory laparotomy. None of the 733 patients who underwent operative
laparoscopy suffered ureteral injury. The incidence of ureteral injury in patients who had ureteral catheters
placed before exploratory laparotomy was 2 (0.62%) of 322. Two (0.10%) of 2016 patients who did not have
prophylactic ureteral catheters suffered a ureteral injury. There was no statistically significant difference in
the incidence of ureteral injury between patients who did and patients who did not undérgó ureteral
catheterization (P = 0.094).
Conclusions. The use of prophylactic ureteral catheters did not affect the rate of ureteral injury in our
patients. The very low incidence of ureteral injury among our patients is attributed mainly to meticulous
surgical technique. UROLOGY 52: 1004-1008, 1998. © 1998, Elsevier Science Inc. All rights reserved.
perative to ureters is an uncommon but ureter is probably the optimal method to avoid ure-
O
injury
serious complication of pelvic sur- teral some pelvic surgeons suggest that pre-
potentially injury,
gery. Gynecologic procedures account for most of operative placement of ureteral catheters may aid
these injuries.L2 The risk of injury to a ureter is in the identification of the ureters. The decision to
increased when difficult pelvic dissections are un- place ureteral catheters is based primarily on the
dertaken for either benign or malignant abnormal- surgeon's subjective view of the anticipated diffi-
ities. The ureter is most injured at the of a particularcase. Many factors influ-
commonly culty may
level of the infundibulopelvic the uterine ence this the clinical diagno-
ligament, evaluation, including
artery, and the angles of the vagina.3,4 Although sis, the patient's body habitus, the size of the pelvic
careful surgical technique with exploration of the mass, and the patient's previous medical and sur-
retroperitoneum and direct visualization of the gical history.
Conversely, there are gynecologic surgeons who
question the benefit of prophylactic ureteral cath-
From the Department of Obstetrics and Gynecology, Division of
eters.4,5 published reports the efficacy of
Gynecologic Oncology, and Departments of Quality Management regarding
and Biostatistics, North Shore University Hospital, Manhasset, prophylactic ureteral catheterization are mainly
New York from the experience in colorectal surgery.1-2·6·7
Reprint requests: David Gal, M.D., Division of Gynecologic There are no such in the gynecologic liter-
reports
Oncology, North Shore University Hospital, 300 Community
ature. We reviewed the North Shore Universit
Drive, Manhasset, NY 11030
Submitted: May 11, 1998, accepted (with revisions): June 22, Hospital experience with prophylactic ureteral
1998 catheters in gynecologic surgery. The frequency of
© 1998, ELSEVIER
SCIENCEINC, 0090-4295/98/$19.00
1004 ALLRIGHTSRESERVED PII S0090-4295(98)00382-3
FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015
NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020
TABLE 1. Breakdown of surgicci prùcédürés TABLE II. Mean operative time by surgical
Ureteral prùcedure
Catheterization Operative Time (min)
Procedure n Yes (%) No (%) Ureteral No Ureteral
2338 Procedure (n) Catheters Catheters
Laparotomy
TAH/BSO 152 (14.6) 891 (85.4) Laparotomy (2338) 139.2 ± 30.7 147.4 ± 39.1
Adnexectomy 71 (14,0) 434 (86.0) Laparoscopy (733) 186.4 ± 38.5 165.8 ± 42.2
Myomectomy 23 (13.4) 145 (86.6) Cystoscopy and ureteral 17.0 ± 4.2 NA
Lysis of adhesion 21 (15.5) 114 (84.5) catheter insertion
Radical hysterectomy 2 (0.2) 106 (98.8) (469)
Cytoreduction 32 (11.6) 244 (88.4)
KEy:NA = notapplicable.
Bowel resection 21 (20.4) 82 (79.6) Valuesaren1ean± standarddeviation.
Laparoscopy 733
LAVH 56 (28.0) 200 (72.0)
Adnexectomy 61 (22.1) 276 (77.9) RESULTS
Fulguration* 18 (20.9) 68 (79.1)
There were a total of 6348 gynecologic proce-
Myomectomy 12 (22.2) 42 (77.8) .
dures performed at North Shore Hosp1-
University
KEY:TAH/BSO= totalabdontinalhysterectonty,
bilateralsä|y:ñgo-üü
±arectonty; proce-
tal during the study period. Of these, 3071
LAVH = laparoscopic-assisted
vaginalhysterectonry.
*naguämofendsta a dures satisfied the inclusion criteria for the study.
There were 2338 laparoto-
(76.1%) exploratory
mies and 733 (23.9%) operative laparoscopies. The
. . . breakdown of the surgical procedures is detailed in
prophylactic ureteral catheterization, its efficacy m
. Table I. The mean operative time for exploratory
preventing ureteral injury, and the compheations cystos-
laparotomy, operative laparoscopy, and
associated with the procedure were studied.
copy with ureteral catheterization are detailed in
Table II.
MATERIAL AND METHODS The overall ureteral catheterization rate during
the study period was 469 (15.3%) of 3071. Ureteral
All major gynecologic procedures performed at North Shore catheterization was performed in 322 (13.8%) of
University Hospital between January 1, 1992 and December 2338 atients who underwent an explorato lap-
31, 1994 were identified using a computer data base main-
arotomy and in 147 (20.1%) of 733 patients who
tained by the operating room staff. To limit the study group to
patients who were potential candidates for prophylactic ure- underwent operative laparoscopy. In all instances,
teral catheterization, we elimimted all extraperitoneal proce- bilateral ureteral catheters were placed and there
"minor"
dures. Additionally, we excluded gynecologic cases, were no failures in catheterization.
with an operative time of less than 90 minutes, to limit the complica- tract
Fifty-four patients with urinary
control group to procedures with a degree of difficulty that .
ure- tions, other than a simple urinary tract mfection,
would make them potential candidates for prophylactic
teral catheterization. opera- were identified the study period. The med-
Among patients who underwent during
tive laparoscopy, we confined the study to patients with a ical records of these patients were reviewed. Ure-
diagnosis of malignancy or severe endometriosis, or those that teral injuries were recorded in 4 (0.13%) of 3071
underwent a laparoscopic-assisted vaginal hysterectomy. All surgical cathe-
patients. The diagnosis, procedure,
surgical procedures in our institution are performed by an
ter status, type of injury, time to recognition, and
attending obstetrician-gynecologist with the assistance of a
fourth year gynu ology resident. The type and length of each management are detailed in Table III. None of the
procedure was determined from the operating room data base. patients who underwent operative laparoscopy
The procedures in which prophylactic ureteral catheters were the period suffered from a ureteral
during study
placed were also identified from the same data base. Ureteral (Table IV). Two of 2016 patients
WD WM mm & ¾e a
injury (0.1%)
catheterization was always performed using cystoscopy, by an
opera- dfd a
attending urologist, before exploratory laparotomy or
tive laparoscopy. The procedure time for cystoscopy and ure- underwent exploratory laparotomy and did not
teral catheterization was also noted. Catheters were com- have prophylactic ureteral catheterization, and 2
monly removed in the operating room at the completion of the of 322 patients who underwent explor-
(0.62%)
pelvic operative procedure. with prophylactic ureteral cath-
and postoperative atory laparotomy
All intraoperative complications at our
eterization suffered i n u ry (P =
a similar ureteral
institution are tracked by the Department of Quality Manage-
0.094). There were no cases of reflux anuria re-
ment. Their data base allowed identification of all patients
with urinary tract complications. We reviewed the medical ported in patients with prophylactic ureteral cath-
records of patients with urinary complications and identi&ed eterization. The overall rate of postoperative uri-
those that suffered ureteral injury. Fisher's exact test was used infection was 387 of 3071
nary tract (12.6%)
to compare ureteral complications surgi-
among the different The rates in catheterized and noncath-
cal groups. Chi-square analysis was used for comparisons of P atients.
eterized patients were 61 (13.0%) of 469 and 326
urinary tract infection rates, and Student's t test was used to
calculate differences in hospital stay. of 2602 respectively. Prophylac-
(12.5%) patients,
UROLOGY 52 (6), 1998 1005
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TABLE Ill. Patients with ureteral injury
Patient Age Ureteral
No. (yr) Diagnosis Procedure Catheter T Type of Injury Treatment
1 53 Leiyomyomata TAH/BSO No 6 Left ureteral Double J stent
obstruction in
lower third
2 60 Endometrial TAH/BSO, LND No 14 Right ureteral Double J stent,
cancer obstruction in antibiotics
lower third,
urosepsis
3 50 Leiyomyomata TAH/BSO Yes 11 Right Ureteroneocystotomy
ureterovaginal
fistula
4 51 Recurrent ovarian Cytoreduction, Yes 4 Left Double J stent
cancer bowel ureterovaginal
resection fistula
KEY:r timeOfinjury (postOperative bilateral:dy!q;: ::ph:r::tOmy; LND = pelvicandperiaortic!ymp ± x
day); TAH/BSO= total abdominalhysterectomy,
believe that in difficult pelvic dis-
catheterization,
TABLE IV. Number of patients with ureteral
sections, where edema and infhmmatory reaction
injury by surgical group
prevail, ureteral catheters often cannot be felt
Pro hylactl reteral
through the peritoneum, and are of little help in
identifying the ureter.
Procedure Yes (%) No (%)
Although there are no studies in the gynecologic
Exploratory laparotomy 2/322 (0.62) 2/201 6 (0.10) catheter-
literature regarding prophylactic ureteral
Operative laparoscopy 0/147 (0.00) 0/586 (0.00) ad-
ization, several investigatorsrecently have
dressed this topic in the field of colorectal surgery
(Table V). Bothwellet al.6 reported on their expe-
tic ureteral catheterization did not al- 561 patients rectosigmoid
significantly rience with undergoing
ter the incidence of urinary tract infection in the a 5-year period. Ninety-two pa-
surgery during
(P > 0.7). se-
study population No long-term tients (16.4%) had ureteral catheters placed. A to-
quelae evolved from ureteral injuries. However, tal of four ureteral injuries were noted:
(0.71%)
the mean hospital stay of the 4 patients with a ure- two in the absence of catheters, one with catheters
teral injury (9.4 ± 4.2 days) was significantly in place, and one as a result of the catheterization.
longer than the hospital stay of patients who did With staged removal of catheters over a 24-hour
not have a ureteral injury (5.8 ± 3.5 days) during an-
period, there were no reported cases of reflux
the study period (P < 0.04). placement of
uria. The investigators conclude that
ureteral catheters is associated with a 1% risk of
COMMENT iatrogenic injury and does not prevent surgical
damage to the ureter; however, they added that
The incidence of ureteral injuries in gynecologic
catheters may aid in intraoperative detection of
surgery varies from 0.2% to 2.5%. Injuries most
ureteral injury.
commonly occur in radical procedures, performed
malignancies.4·8-10 knowl- Kyzer and Gordon12 reviewed their experience in
for gynecologic Detailed
me- a similar population. Using a retrospective system
edge of retroperitoneal anatomy coupled with
dissection and visual identification of the for grading the necessity for ureteral catheters,
ticulous
iatro- these investigators suggest that catheterization was
ureter are the cornerstones to preventing
genic ureteral injury. beneficial in 27.5% of their patients. The single
The benefits
of prophylactic ureteral catheters in case of ureteral injury among 118 patients was de-
pelvic are controversial. Shingleton5 and tected during surgery as a result of the presence of
surgery
Buchsbaum and Schmidt4 Suggest that the pres- a catheter.12 They suggest that ureteral catheters
ence of a catheter increases the likelihood of injury may aid in intraoperative identification of injuries
the ureter their pliability. Falk11 and therefore optimize the management of such
to by reducing
cautioned that catheters situate the ureter in iatrogenic injuries. Neuman et al.8 report that less
may
an ectopic location and thus increase the risk of than one third of ureteral injuries are identified at
inadvertent injury. These investigators, who are the time of gynecologic surgery. Careful inspection
opposed to the routine use of prophylactic ureteral of the ureters before abdominal closure may be as
1006 UROLOGY 52 (6), 1998
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TABLE V. Review of the literature on the incidence of ureteral injury during pelvic surgery
__
Ureteral Injuries
With Without
Surgical Catheters Catheters
Author Year Specialty n (%) (%)
Leff et al.7 1982 Colorectal 198 4/198 (2.0) None
Sheikh et al.16 1990 Colorectal 59 0/59 (0.0) None
Kyzer et al.12 1994 Colorectal 118 1/118 (0.8) None
Bothwell et al.6 1994 Colorectal 561 2/92 (2.2) 2/469 (0.4)
Present study 1996 Gynecologic 3071 2/469 (0.4) 2/2602 (0.07)
Total - - 4009 9/938 (0.9) 4/3071 (0.13)
critical as the direct visualization of the ureters with caution because of the retrospective nature of
before ligation of vascular pedicles.4 our and the lack of objective parameters for
study
Catheterization itself is not without complica- the difficulty of pelvic procedures. We
grading
tions. There is an increased risk
of urinary tract have tried to reduce selective bias by using strict
infection as a result of cystoscopy and ureteral inclusion criteria that may render the control
An-
catheterization. This was not confirmed by our group similar to the catheterization group.
present investigation nor in several previous stud- other limitation of this is in the inability to
study
ies.13·¹4 surgeons' expe-
Early removal of the catheters and the use control for differences in operative
of perioperative antibiotics these statistical difficul-
may have contributed rience and skill. However,
to the reduction of this sequela in our patients. ties are inherent in any retrospective, large-scale
Reflux anuria is an uncommon of complication study conducted in a community hospital with a
ureteral catheterization. It may be the result of ure- large voluntary staff and private patients who com-
terovesical junction edema, which causes obstruc- monly refuse randomization.
tion to urine flow.7 Others suggest that generalized Finally, the use of prophylactic ureteral catheters
renal cortical vasoconstriction, as a result of ure- in our institution adds approximately $1465 per
teral stimulation, may lead to decreased glomeru- procedure. This figure includes the cost of addi-
lar filtration and transient anuria.15.16 Sheikh and tional room time, and urologist
operating supplies,
Khubchandanil6 encountered 3 of 59 patients with and anesthesiologist fees.
reflux anuria after catheterization. recom-
They
mend a staged removal of catheters over 24 hours CONCLUSIONS
to avoid this complication. They note, however,
In our the incidence of ureteral in-
that anuria occurred in one of their patients despite institution,
jury in patients who underwent gynecologic pelvic
this practice.
was low (0.13%). prophylactic
Bhargava and Usuf17 identified a case of uretero- surgery However,
ureteral catheterization did not eliminate ureteral
Preview
FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015 NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020 EXHIBIT R FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015 NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020 ADULT UROLOGY . , CME ARTICLE ELSEVIER PROPHYLACTIC URETERAL CATHETERIZATION IN GYNECOLOGIC SURGERY KAZUNARI KUNO, ANDREW MENZIN, H. HUGH KAUDER, CRISTINA SISON, AND DAVID GAL ABSTRACT Objectives. To examine the frequency of ureteral catheter usage, its efficacy in preventing injury, and related complications, because the preoperative routine placement of ureteral catheters as a prophylactic measure to prevent ureteral injury is controversial. Methods. All major gyilecclagic operations performed between January 1992 and December 1994 were identified. All gynecologic procedures that were preceded iden- by ureteral catheter placement were also tified. A data base maintained by the Department of Quality Management allowed identification of all urinary tract cGmplications and ureteral injuries. Four categories of surgery were analyzed: exploratory laparotomy with catheters, exploratory laparotomy without catheters, operative laparoscopy with catheters, and oper- ative laparoscopy without catheters. The medical records of all patients with urinary tract complications were reviewed. Results. Bilateral prophylactic ureteral catheterization was performed in 469 (15.3%) of 3071 patients. A ureteral injury occurred in 4 (0.13%) of 3071 patients. All four ureteral injuries (0.17%) occurred among 2338 patients who underwent exploratory laparotomy. None of the 733 patients who underwent operative laparoscopy suffered ureteral injury. The incidence of ureteral injury in patients who had ureteral catheters placed before exploratory laparotomy was 2 (0.62%) of 322. Two (0.10%) of 2016 patients who did not have prophylactic ureteral catheters suffered a ureteral injury. There was no statistically significant difference in the incidence of ureteral injury between patients who did and patients who did not undérgó ureteral catheterization (P = 0.094). Conclusions. The use of prophylactic ureteral catheters did not affect the rate of ureteral injury in our patients. The very low incidence of ureteral injury among our patients is attributed mainly to meticulous surgical technique. UROLOGY 52: 1004-1008, 1998. © 1998, Elsevier Science Inc. All rights reserved. perative to ureters is an uncommon but ureter is probably the optimal method to avoid ure- O injury serious complication of pelvic sur- teral some pelvic surgeons suggest that pre- potentially injury, gery. Gynecologic procedures account for most of operative placement of ureteral catheters may aid these injuries.L2 The risk of injury to a ureter is in the identification of the ureters. The decision to increased when difficult pelvic dissections are un- place ureteral catheters is based primarily on the dertaken for either benign or malignant abnormal- surgeon's subjective view of the anticipated diffi- ities. The ureter is most injured at the of a particularcase. Many factors influ- commonly culty may level of the infundibulopelvic the uterine ence this the clinical diagno- ligament, evaluation, including artery, and the angles of the vagina.3,4 Although sis, the patient's body habitus, the size of the pelvic careful surgical technique with exploration of the mass, and the patient's previous medical and sur- retroperitoneum and direct visualization of the gical history. Conversely, there are gynecologic surgeons who question the benefit of prophylactic ureteral cath- From the Department of Obstetrics and Gynecology, Division of eters.4,5 published reports the efficacy of Gynecologic Oncology, and Departments of Quality Management regarding and Biostatistics, North Shore University Hospital, Manhasset, prophylactic ureteral catheterization are mainly New York from the experience in colorectal surgery.1-2·6·7 Reprint requests: David Gal, M.D., Division of Gynecologic There are no such in the gynecologic liter- reports Oncology, North Shore University Hospital, 300 Community ature. We reviewed the North Shore Universit Drive, Manhasset, NY 11030 Submitted: May 11, 1998, accepted (with revisions): June 22, Hospital experience with prophylactic ureteral 1998 catheters in gynecologic surgery. The frequency of © 1998, ELSEVIER SCIENCEINC, 0090-4295/98/$19.00 1004 ALLRIGHTSRESERVED PII S0090-4295(98)00382-3 FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015 NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020 TABLE 1. Breakdown of surgicci prùcédürés TABLE II. Mean operative time by surgical Ureteral prùcedure Catheterization Operative Time (min) Procedure n Yes (%) No (%) Ureteral No Ureteral 2338 Procedure (n) Catheters Catheters Laparotomy TAH/BSO 152 (14.6) 891 (85.4) Laparotomy (2338) 139.2 ± 30.7 147.4 ± 39.1 Adnexectomy 71 (14,0) 434 (86.0) Laparoscopy (733) 186.4 ± 38.5 165.8 ± 42.2 Myomectomy 23 (13.4) 145 (86.6) Cystoscopy and ureteral 17.0 ± 4.2 NA Lysis of adhesion 21 (15.5) 114 (84.5) catheter insertion Radical hysterectomy 2 (0.2) 106 (98.8) (469) Cytoreduction 32 (11.6) 244 (88.4) KEy:NA = notapplicable. Bowel resection 21 (20.4) 82 (79.6) Valuesaren1ean± standarddeviation. Laparoscopy 733 LAVH 56 (28.0) 200 (72.0) Adnexectomy 61 (22.1) 276 (77.9) RESULTS Fulguration* 18 (20.9) 68 (79.1) There were a total of 6348 gynecologic proce- Myomectomy 12 (22.2) 42 (77.8) . dures performed at North Shore Hosp1- University KEY:TAH/BSO= totalabdontinalhysterectonty, bilateralsä|y:ñgo-üü ±arectonty; proce- tal during the study period. Of these, 3071 LAVH = laparoscopic-assisted vaginalhysterectonry. *naguämofendsta a dures satisfied the inclusion criteria for the study. There were 2338 laparoto- (76.1%) exploratory mies and 733 (23.9%) operative laparoscopies. The . . . breakdown of the surgical procedures is detailed in prophylactic ureteral catheterization, its efficacy m . Table I. The mean operative time for exploratory preventing ureteral injury, and the compheations cystos- laparotomy, operative laparoscopy, and associated with the procedure were studied. copy with ureteral catheterization are detailed in Table II. MATERIAL AND METHODS The overall ureteral catheterization rate during the study period was 469 (15.3%) of 3071. Ureteral All major gynecologic procedures performed at North Shore catheterization was performed in 322 (13.8%) of University Hospital between January 1, 1992 and December 2338 atients who underwent an explorato lap- 31, 1994 were identified using a computer data base main- arotomy and in 147 (20.1%) of 733 patients who tained by the operating room staff. To limit the study group to patients who were potential candidates for prophylactic ure- underwent operative laparoscopy. In all instances, teral catheterization, we elimimted all extraperitoneal proce- bilateral ureteral catheters were placed and there "minor" dures. Additionally, we excluded gynecologic cases, were no failures in catheterization. with an operative time of less than 90 minutes, to limit the complica- tract Fifty-four patients with urinary control group to procedures with a degree of difficulty that . ure- tions, other than a simple urinary tract mfection, would make them potential candidates for prophylactic teral catheterization. opera- were identified the study period. The med- Among patients who underwent during tive laparoscopy, we confined the study to patients with a ical records of these patients were reviewed. Ure- diagnosis of malignancy or severe endometriosis, or those that teral injuries were recorded in 4 (0.13%) of 3071 underwent a laparoscopic-assisted vaginal hysterectomy. All surgical cathe- patients. The diagnosis, procedure, surgical procedures in our institution are performed by an ter status, type of injury, time to recognition, and attending obstetrician-gynecologist with the assistance of a fourth year gynu ology resident. The type and length of each management are detailed in Table III. None of the procedure was determined from the operating room data base. patients who underwent operative laparoscopy The procedures in which prophylactic ureteral catheters were the period suffered from a ureteral during study placed were also identified from the same data base. Ureteral (Table IV). Two of 2016 patients WD WM mm & ¾e a injury (0.1%) catheterization was always performed using cystoscopy, by an opera- dfd a attending urologist, before exploratory laparotomy or tive laparoscopy. The procedure time for cystoscopy and ure- underwent exploratory laparotomy and did not teral catheterization was also noted. Catheters were com- have prophylactic ureteral catheterization, and 2 monly removed in the operating room at the completion of the of 322 patients who underwent explor- (0.62%) pelvic operative procedure. with prophylactic ureteral cath- and postoperative atory laparotomy All intraoperative complications at our eterization suffered i n u ry (P = a similar ureteral institution are tracked by the Department of Quality Manage- 0.094). There were no cases of reflux anuria re- ment. Their data base allowed identification of all patients with urinary tract complications. We reviewed the medical ported in patients with prophylactic ureteral cath- records of patients with urinary complications and identi&ed eterization. The overall rate of postoperative uri- those that suffered ureteral injury. Fisher's exact test was used infection was 387 of 3071 nary tract (12.6%) to compare ureteral complications surgi- among the different The rates in catheterized and noncath- cal groups. Chi-square analysis was used for comparisons of P atients. eterized patients were 61 (13.0%) of 469 and 326 urinary tract infection rates, and Student's t test was used to calculate differences in hospital stay. of 2602 respectively. Prophylac- (12.5%) patients, UROLOGY 52 (6), 1998 1005 FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015 NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020 TABLE Ill. Patients with ureteral injury Patient Age Ureteral No. (yr) Diagnosis Procedure Catheter T Type of Injury Treatment 1 53 Leiyomyomata TAH/BSO No 6 Left ureteral Double J stent obstruction in lower third 2 60 Endometrial TAH/BSO, LND No 14 Right ureteral Double J stent, cancer obstruction in antibiotics lower third, urosepsis 3 50 Leiyomyomata TAH/BSO Yes 11 Right Ureteroneocystotomy ureterovaginal fistula 4 51 Recurrent ovarian Cytoreduction, Yes 4 Left Double J stent cancer bowel ureterovaginal resection fistula KEY:r timeOfinjury (postOperative bilateral:dy!q;: ::ph:r::tOmy; LND = pelvicandperiaortic!ymp ± x day); TAH/BSO= total abdominalhysterectomy, believe that in difficult pelvic dis- catheterization, TABLE IV. Number of patients with ureteral sections, where edema and infhmmatory reaction injury by surgical group prevail, ureteral catheters often cannot be felt Pro hylactl reteral through the peritoneum, and are of little help in identifying the ureter. Procedure Yes (%) No (%) Although there are no studies in the gynecologic Exploratory laparotomy 2/322 (0.62) 2/201 6 (0.10) catheter- literature regarding prophylactic ureteral Operative laparoscopy 0/147 (0.00) 0/586 (0.00) ad- ization, several investigatorsrecently have dressed this topic in the field of colorectal surgery (Table V). Bothwellet al.6 reported on their expe- tic ureteral catheterization did not al- 561 patients rectosigmoid significantly rience with undergoing ter the incidence of urinary tract infection in the a 5-year period. Ninety-two pa- surgery during (P > 0.7). se- study population No long-term tients (16.4%) had ureteral catheters placed. A to- quelae evolved from ureteral injuries. However, tal of four ureteral injuries were noted: (0.71%) the mean hospital stay of the 4 patients with a ure- two in the absence of catheters, one with catheters teral injury (9.4 ± 4.2 days) was significantly in place, and one as a result of the catheterization. longer than the hospital stay of patients who did With staged removal of catheters over a 24-hour not have a ureteral injury (5.8 ± 3.5 days) during an- period, there were no reported cases of reflux the study period (P < 0.04). placement of uria. The investigators conclude that ureteral catheters is associated with a 1% risk of COMMENT iatrogenic injury and does not prevent surgical damage to the ureter; however, they added that The incidence of ureteral injuries in gynecologic catheters may aid in intraoperative detection of surgery varies from 0.2% to 2.5%. Injuries most ureteral injury. commonly occur in radical procedures, performed malignancies.4·8-10 knowl- Kyzer and Gordon12 reviewed their experience in for gynecologic Detailed me- a similar population. Using a retrospective system edge of retroperitoneal anatomy coupled with dissection and visual identification of the for grading the necessity for ureteral catheters, ticulous iatro- these investigators suggest that catheterization was ureter are the cornerstones to preventing genic ureteral injury. beneficial in 27.5% of their patients. The single The benefits of prophylactic ureteral catheters in case of ureteral injury among 118 patients was de- pelvic are controversial. Shingleton5 and tected during surgery as a result of the presence of surgery Buchsbaum and Schmidt4 Suggest that the pres- a catheter.12 They suggest that ureteral catheters ence of a catheter increases the likelihood of injury may aid in intraoperative identification of injuries the ureter their pliability. Falk11 and therefore optimize the management of such to by reducing cautioned that catheters situate the ureter in iatrogenic injuries. Neuman et al.8 report that less may an ectopic location and thus increase the risk of than one third of ureteral injuries are identified at inadvertent injury. These investigators, who are the time of gynecologic surgery. Careful inspection opposed to the routine use of prophylactic ureteral of the ureters before abdominal closure may be as 1006 UROLOGY 52 (6), 1998 FILED: NEW YORK COUNTY CLERK 09/25/2020 01:28 PM INDEX NO. 805302/2015 NYSCEF DOC. NO. 136 RECEIVED NYSCEF: 09/25/2020 TABLE V. Review of the literature on the incidence of ureteral injury during pelvic surgery __ Ureteral Injuries With Without Surgical Catheters Catheters Author Year Specialty n (%) (%) Leff et al.7 1982 Colorectal 198 4/198 (2.0) None Sheikh et al.16 1990 Colorectal 59 0/59 (0.0) None Kyzer et al.12 1994 Colorectal 118 1/118 (0.8) None Bothwell et al.6 1994 Colorectal 561 2/92 (2.2) 2/469 (0.4) Present study 1996 Gynecologic 3071 2/469 (0.4) 2/2602 (0.07) Total - - 4009 9/938 (0.9) 4/3071 (0.13) critical as the direct visualization of the ureters with caution because of the retrospective nature of before ligation of vascular pedicles.4 our and the lack of objective parameters for study Catheterization itself is not without complica- the difficulty of pelvic procedures. We grading tions. There is an increased risk of urinary tract have tried to reduce selective bias by using strict infection as a result of cystoscopy and ureteral inclusion criteria that may render the control An- catheterization. This was not confirmed by our group similar to the catheterization group. present investigation nor in several previous stud- other limitation of this is in the inability to study ies.13·¹4 surgeons' expe- Early removal of the catheters and the use control for differences in operative of perioperative antibiotics these statistical difficul- may have contributed rience and skill. However, to the reduction of this sequela in our patients. ties are inherent in any retrospective, large-scale Reflux anuria is an uncommon of complication study conducted in a community hospital with a ureteral catheterization. It may be the result of ure- large voluntary staff and private patients who com- terovesical junction edema, which causes obstruc- monly refuse randomization. tion to urine flow.7 Others suggest that generalized Finally, the use of prophylactic ureteral catheters renal cortical vasoconstriction, as a result of ure- in our institution adds approximately $1465 per teral stimulation, may lead to decreased glomeru- procedure. This figure includes the cost of addi- lar filtration and transient anuria.15.16 Sheikh and tional room time, and urologist operating supplies, Khubchandanil6 encountered 3 of 59 patients with and anesthesiologist fees. reflux anuria after catheterization. recom- They mend a staged removal of catheters over 24 hours CONCLUSIONS to avoid this complication. They note, however, In our the incidence of ureteral in- that anuria occurred in one of their patients despite institution, jury in patients who underwent gynecologic pelvic this practice. was low (0.13%). prophylactic Bhargava and Usuf17 identified a case of uretero- surgery However, ureteral catheterization did not eliminate ureteral