Updates in Surgery (2020) 72:1247–1254
https://doi.org/10.1007/s13304-019-00681-w
ORIGINAL ARTICLE
Uterine manipulator in total laparoscopic hysterectomy: safety
and usefulness
Yara Abdel Khalek1 · Roger Bitar2 · Costas Christoforou3 · Simone Garzon4 · Alessandro Tropea5 · Antonio Biondi6 ·
Zaki Sleiman1,2
Received: 14 July 2019 / Accepted: 21 September 2019 / Published online: 12 October 2019
© Italian Society of Surgery (SIC) 2019
Abstract
The aim of this review is to evaluate the effectiveness and safety of uterine manipulators in facilitating total laparoscopic
hysterectomy (TLH). A literature search in MEDLINE, EMBASE, Cochrane Library, UpToDate, SpringerLink, ClinicalKey and Elsevier ScienceDirect databases was performed, and articles describing TLH with or without the use of uterine
manipulators were retrieved. Complications related to the use of uterine manipulators are numerous, and although uterine
manipulator seems to facilitate TLH, the procedure without a uterine manipulator seems to have a comparable safety and
effectiveness, although evidence based on a direct comparison of the two approaches is limited without available controlled
trials. Uterine manipulator may provide support in cases of large uteri, severe endometriosis, recto vaginal adhesions and
regional anesthesia, while its use may increase complications in cases of vaginal stenosis and nulliparity. Therefore, to perform TLH, the surgeon should individualize for each case if uterine manipulator is needed and which manipulator best suits
the surgical procedure requirements and case characteristics. Further studies comparing the two approaches are mandatory.
Keywords Hysterectomy · Laparoscopy · Uterine manipulator · Surgical Instruments · Intraoperative complications
Introduction
Hysterectomy is the most common gynecological surgical procedure, and it is performed to treat several benign
(85–90%) and malignant (10%) pathologies [1]. Since the
late 1980s, with the development of new minimally invasive
* Zaki Sleiman
zakinexus@hotmail.com
1
Department of Obstetrics and Gynecology, Saint Joseph
University, Beirut, Lebanon
2
Department of Obstetrics and Gynecology, Lebanese
American University, Zahar Street, Beirut, Lebanon
3
Christoforou Clinic, Larnaca, Cyprus
4
Department of Obstetrics and Gynecology, “Filippo Del
Ponte” Hospital, University of Insubria, Varese, Italy
5
Department for the Treatment and Study of Abdominal
Diseases and Abdominal Transplantation,
IRCCS-ISMETT(Istituto Mediterraneo per i Trapianti e
Terapie ad alta specializzazione), University of Pittsburgh
Medical Center Italy, Palermo, Italy
6
Department of General Surgery and Medical Surgical
Specialties, University of Catania, Catania, Italy
laparoscopic technique, the conventional laparotomic and
vaginal approaches for hysterectomy were replaced by total
laparoscopic hysterectomy (TLH), with the first case published in 1993 [2]. TLH gained a rapid popularity since it
is associated with high rate of patient satisfaction, allowing
rapid recovery and less postoperative pain and hospital stay,
that is particularly useful in fragile patients [3, 4]. Surgeons,
as well, preferred this new approach for hysterectomy, and
started developing techniques and tools to make this surgery
safer and faster.
One of the main instruments designed to improve the performance of TLH is the uterine manipulator. A huge variety of
uterine manipulators are developed to suit the different sizes
of uterine cavities and shapes of the cervix, representing the
easiest way to mobilize the uterus and to achieve an adequate
exposure of the operative field, thus minimizing damage to
noble structures in the pelvis, and facilitating colpotomy. Nevertheless, complications arising from the use of manipulators
are reported, and the correct use is mandatory to avoid that risk
outweigh the advantages [5]. On that basis, the TLH without
the use of a uterine manipulator was proposed, such as a new
approach based on a four-port laparoscopy. In the absence of
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a uterine manipulator, the lowest trocar is used to generate
the cephalad traction of the uterus away from the ureters [6].
The purpose of this narrative review is, therefore, to assess
the safety and utility of uterine manipulators in TLH comparing this procedure with those performed without the use of
manipulators, identifying crucial gaps that can guide future
research.
Literature search
A literature search was conducted from January 1985 to March
2019 in the following electronic bibliographic databases:
MEDLINE, EMBASE, The Cochrane Library (Cochrane
Database of Systematic Reviews, Cochrane Central Register
of Controlled Trials, Cochrane Methodology Register), UpToDate, SpringerLink, ClinicalKey and Elsevier ScienceDirect.
The search strategy included the combination of the Medical
Subject Heading (MeSH) “Hysterectomy” (MeSH Unique ID:
D007044) with “Laparoscopy” (MeSH Unique ID: D010535),
“Hand-Assisted Laparoscopy” (MeSH Unique ID: D058733),
“Surgical Instruments” (MeSH Unique ID: D013525) and
“Intraoperative Complications” (MeSH Unique ID: D007431).
Articles describing TLH with or without the use of uterine
manipulator were included and reviewed, as well as articles
describing the uterine manipulators or reporting about complications. We included all types of manuscript. Titles and
abstracts of retrieved studies using the search strategy, and
those from additional sources, were screened independently by
two review authors (XX., YY) to identify studies that potentially meet the topic. The full text of these potentially eligible
studies was retrieved and independently assessed for eligibility
by other two review team members (XX, YY). Any discrepancies were solved through a discussion with a third external
collaborator.
The literature search identified many studies [1, 7–19],
multiple case reports [20–26] and three literature reviews
[5, 27, 28] reporting about TLH performed with the use of
ten different types of uterine manipulators. One literature
review focused about the effect of uterine manipulator on the
anatomical relationship between the ureter and the uterine
vessels [29]. Conversely, a few studies were identified focusing on TLH learning curve [30–32], and a limited number
was found discussing about TLH without the use of uterine
manipulator [2, 6, 33, 34]. Neither randomized control trials nor controlled prospective studies comparing the two
approaches were identified.
Uterine manipulator and uterine size
Many studies demonstrated the feasibility of removing large
size uteri by TLH [28]. Recently, a prospective study performed in 2016 on 461 cases confirmed that laparoscopic
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Updates in Surgery (2020) 72:1247–1254
hysterectomy is feasible and safe independently of the uterine weight with the use of uterine manipulator [7]. The biggest uteri removed by laparoscopy till now weighted 6095 g
and 5320 g, the last one was performed with a blood loss
of 300 mL and an operative time of 200 min [20, 21], both
performed using a uterine manipulator. These procedures
were performed safely without complications.
On the other hand, although different studies report about
TLH without the use of a uterine manipulator in almost
regular size uteri, only case reports focused on TLH for
particularly huge uteri [2, 6, 33, 34]. The biggest uterus to
date weighted 5700 g (blood loss 50 mL, operative time
220 min), and another uterus of 3670 g with severe lymph
node invasive disease was also performed by laparoscopy.
Both surgical procedures were completed without the use of
a uterine manipulator, with any associated complications [2].
On that basis, uterine weight does not seem to be a barrier
for the TLH regardless the use of a uterine manipulator. The
safe upper weight limit is undetermined, and case reports
up to now show identical results for both strategies (5320 g
versus 5700 g, respectively), without any increase in the rate
of complications.
Uterine manipulator, operative time
and blood loss
The mean operative time of TLH using a uterine manipulator ranges between 83 and 136 min, as published in the
biggest series of laparoscopic hysterectomies [8, 15, 17–19]
(Table 1).
Moreover, operative time seems to vary according and
proportional to the uterine size. A retrospective study conducted on 435 TLH using a RUMI manipulator showed a
mean operating time ranging from 40 min, for 5 cm length
uterus up to 257 min, for a uterine size of 17 cm, with a
mean of 136 min. Similarly, blood loss resulted proportional
to the uterine size, ranging from 50 mL up to 1500 mL and
with a mean of 313 mL [8].
Table 1 Mean operative time of TLH using a uterine manipulator in
the biggest published series
Published series
Number of TLH
Mean Operating Time (min)
Ng 2007
Cook 2004
Wattie 2009
Chapron 1998
Garry 2004
435
424
1647
313
920
136
122
101
141
83
Total laparoscopic hysterectomy (TLH)
Updates in Surgery (2020) 72:1247–1254
Till now, no studies designed to compare these outcomes
between randomized groups of TLH with or without manipulators exist. Therefore, we performed a review of published
series trying to find the most comparable reported groups
of TLH with and without a uterine manipulator. Two studies were chosen [6, 15], based on a mean uterine weight
of 263 g and 292 g, respectively. The mean operating time
for TLH performed with a uterine manipulator was 90 min
(40–180 min) for a mean uterine weight of 292 g (40–980 g)
[15], while the procedure performed without a manipulator
requires a mean of 98 min with salpingo-oophorectomy and
80 min without salpingo-oophorectomy for a mean uterine
weight of 263 g [6].
Uterine manipulator and learning curve
The learning curve of any surgical procedure is analyzed
depending on the variables that may improve the general
outcome. The perioperative complications and the operating
time are the main variables studied in the literature. Based
on the learning curve, a surgeon seems to need performing
at least 20–40 TLH with or without a uterine manipulator
to reduce the rate of surgical complications [31]. Later on, a
plateau in the learning curve is achieved after 75 cases [30].
This is confirmed by a significant decrease in the operating
time, without any significant decrease in the rate of complications anymore, although the need for transfusion and the
rate of conversion into laparotomy decreased also significantly after the first 75 cases [30].
Noteworthy, not only the surgeon requires skills and experience to perform a TLH with a uterine manipulator, but also
the entire operating team should be skillful, especially the
assistant who will be in charge of manipulating the uterus.
The learning curve of the assistant is also long and can be
spared in TLH without a manipulator [9]. A study focused on
the learning curves for laparoscopic hysterectomy showed a
faster learning curve among experienced surgeons compared
to inexperienced ones. The duration of surgery decreased
after 20 TLH and after 10 laparoscopic supra-cervical hysterectomy (LSH) among attending surgeons (136 min to
118 min), while this decrease was only noted after 10 LSH
among residents, with no changes for TLH [32].
Uterine manipulator and complications
The mobilization of the uterus away from the ureters is one
of the main purposes of uterine manipulators with the aim
to reduce complications related to TLH. Nevertheless, ureteric and bladder injuries in TLH performed with the use
of uterine manipulator are reported occurring with an incidence of 0.5–1% [6]. Based on our review, studies designed
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to compare ureteric and bladder injury rates between randomized groups of TLH with or without manipulators are
not available, and evidence reporting about the rate of ureteric and bladder injuries in TLH performed without uterine
manipulator are inadequate.
Meanwhile, different complications directly arising from
the use of uterine manipulators are described. Uterine rupture due to over inflation of the manipulator balloon is often
reported [5, 25]. Cases of bowel perforation and uterine
rupture with the use of Hohl manipulator, lacerations of
the vagina with excessive bleeding with V-care and RUMI
manipulators, melting of the cervical cup in V-care manipulator, and manipulator disintegration inside the patients with
Clearview, V-care, and RUMI manipulators are described
[5, 22, 23]. Moreover, a case of uterine pseudoaneurysm
and massive vaginal bleeding after laparoscopy for ovarian cyst assisted by a uterine manipulator (Atom Medical,
Tokyo, Japan) was published [24], suggesting that traumatic
injury of uterine vessels is a major potential risk of the uterine manipulators. Table 2 summarizes major complications
related to the different types of uterine manipulators. Noteworthy, studies comparing the rate of all complications in
the two alternative approaches do not exist.
Uterine manipulator and cancer
Most TLH are performed to treat benign gynecological
pathologies, but since 2014, TLH became the authorized
standard surgical intervention to treat early stage endometrial cancer when a fertility sparing approach is not request
or allowed [10, 35–37]. Nevertheless, concerns regarding
dissemination of malignant cells into the peritoneal cavity
in TLH performed with a uterine manipulator in early stage
endometrial cancer are noted after studies showing increased
number of malignant cells in the peritoneal washings while
using a manipulator, thereby potentially affecting disease
Table 2 Major complications caused by uterine manipulators
Manipulator
Major Complication
RUMI
Uterine rupture
Disintegration inside the patient
Vaginal wall laceration/excess hemorrhage
Bowel perforation
Uterine rupture
Cervical cup melting
Disintegration inside the patient
Uterine rupture
Disintegration inside the patient
Uterine perforation
Uterine pseudoaneurysm
Hohl
V-care
Clearview
Atom Medical, Tokyo,
Japan
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recurrence [10]. This was supposed related to the retrograde
dissemination of the endometrial neoplastic cells after friction of the manipulator tip on the endometrium and the pressure of the balloon in the uterine cavity [5]. On that basis,
some surgeons suggested to perform tubal cauterization or
ligation before manipulator placement, reporting a reduction of positive cytology conversion after the insertion of
the uterine manipulator [10, 38]. Moreover, some studies
claimed that TLH performed with a manipulator is associated with more vaginal cuff relapses [22]. Nevertheless,
other studies did not find an increase rate of positive peritoneal cytology after the use of uterine manipulator [12, 39].
Additionally, studies on clinic-pathological parameters, with
or without a manipulator use, were conducted in patients
with early stages endometrial and cervical cancers treated
with TLH. These studies showed no influence of the manipulator on the histological parameters, such as frequency of
lymphovascular space invasion [40], and reported no evidence of a clear relationship between uterine manipulators
and cancer recurrence and disease-specific overall survival
[5, 13]. Likewise, no direct relationship was proved between
uterine manipulators and vaginal cuff relapses [22], so TLH
for early stage cancers with a uterine manipulator is as safe
and effective as the laparotomic approach with the advantages to perform adequate sentinel lymph node mapping [14,
41–43].
Uterine manipulators and cost
A cost analysis of uterine manipulator use in TLH is difficult to be performed due to the variability of prices
between countries and even between hospitals. Moreover,
some manipulators are not reusable such as Clearview and
V-care, while other such as RUMI manipulators are partially
or completely reusable. One study on cost reduction of laparoscopic hysterectomy concluded that uterine manipulators
represent the 8% of the total cost [16]. In general, although
some manipulators are disposable, while others are reusable; in all cases, the uterine manipulators are considered
one of the most expensive instruments used in laparoscopic
surgeries [5, 44].
Limits of uterine manipulators
Many studies compared uterine manipulators used in laparoscopic hysterectomy and highlighted their various advantages and disadvantages (Table 3). Some uterine manipulators are difficult to assemble (Clermont Ferrand and RUMI
manipulators) [5, 27]. Some are difficult to manipulate, so
they require training for the second assistant who will hold
and mobilize the uterus during the procedure. Additionally,
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many manipulators require dilatation of the uterine cervix
before insertion, especially the Clermont Ferrand manipulator needing dilatation up to Hegar dilatator number 9, thus
increasing the risk of perforation mainly in cases of vaginal
stenosis and nulliparity [27]. Moreover, although adequate
exposure during the surgery is essential to visualize major
anatomical structures of the pelvis and conduct the TLH
without any complications, some uterine manipulators, such
as Endopath and Hourcabie manipulators, lack the ability to
maintain the pneumoperitoneum or to delineate the vaginal
fornixes, while Hohl and Histerophore manipulators provide
restricted range of uterine motion, limiting the main reasons
to use manipulators [27]. TLH procedures are performed
to remove benign or malignant uteri, that sometimes are
particularly enlarged, so the manipulator should be able to
provide precise manipulation of the uterus regardless the
size. Nevertheless, not all manipulators are adequate for
huge uterus, such as V-care manipulator that seems to be
too light and consequently unable to mobilize big uteri [27].
Discussion
An ideal uterine manipulator should have a number of characteristics that make it safe and affordable to use in every
TLH. It should be nonconductive of electricity; quickly
assembled and resistant; easily inserted in the uterus with
the ability to inject solutions into the cavity; capable of
maintaining the pneumoperitoneum; having an optimal
range of mobilization of the uterus even without the need
of a second assistant; and do not cause any major complications [11, 27]. Nevertheless, the ideal uterine manipulator
does not exist, and the knowledge of the limits of each type
allows to choose the most appropriate for each procedure.
In general, this is a key element for every laparoscopic procedure that requires uterine manipulators from TLH to the
repair of vaginal vault prolapse [45–47].
Regarding complications, injuries directly related to the
use of manipulators are reported [5, 22]. On that basis, TLH
Table 3 Disadvantages of uterine manipulators
Manipulator
Disadvantages
Clermont Ferrand
Difficult to assemble
Requires cervical dilatation
Difficult to assemble
Restricted range of uterine motion
Too light/Unable to mobilize big uteri
Difficulty to maintain pneumoperitoneum
Do not delineate vaginal fornices
Difficulty to maintain pneumoperitoneum
Do not delineate vaginal fornices
Restricted range of uterine motion
RUMI
Hohl
V-care
Hourcabie
Endopath
Histerophore
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without a manipulator was proposed as an alternative offering a potential reduction of complications. Moreover, it was
supposed allowing a fastest operative time and independence
from a second assistant. Nevertheless, available evidence for
a comparison is limited and only a limited discussion of the
two alternatives is possible.
Uterine manipulators are thought to be the best way to
mobilize the uterus. It allows exposing the pelvis and pushing the uterus away from vital structures, facilitating the
TLH particularly in large size uteri. However, available
evidence suggests that the uterine weight does not impede
TLH regardless of the uterine manipulator adoption [2, 20,
21]. The safe upper weight limit is undetermined, and case
reports show identical results for both strategies, without
any increase in the rate of complications. Therefore, both
approaches could be considered feasible. These uteri are
typically related to uterine fibroids that can provide not only
high uterine volume but also changed consistency and shape,
representing a risk factor for conversion to open surgery [48,
49]. Moreover, in case of huge uteri, the subsequent required
step to extract the specimen and the concerns regarding morcellation should be stressed, particularly in case of uterine
fibroids, to avoid the prognosis worsening in case of sarcomas [50–53].
Regarding the effectiveness of manipulators to reduce
the complications related to TLH, the surgeons use uterine
manipulators to mobilize the uterus cranially, away from
the ureters and the bladder to avoid urinary damage. The
cephalad motion offers a perpendicular dissection of the
uterine vessels, elevate and expose the pouch of Douglas
and delineate the vaginal fornixes [5]. The cephalad motion
is supposed to increase the distance between the cervix and
the ureters, but this mechanism remains a theory supported
only by experts, without being demonstrated by clinical evidence [5]. Only one study succeeded to prove the actual
increase in distance with the use of uterine manipulators
between the ureter and the cervix, from 38.5 to 58.4 mm and
from 26.5 to 41.7 mm on the right and left side, respectively
[29]. Although an increased distance was documented, the
incidence of ureteric injuries in TLH using uterine manipulators remain a concern (0.5–1%), with uterine manipulators
that do not impede the occurrence of ureteral and bladder
injuries during TLH [6]. Of note, a study showed that the
distance between the ureter and the cervix decreases when
the cervical cup used is larger than needed [5]. These findings are contradictory and worrying, therefore, an assessment of the efficacy and the safety of uterine manipulators
should be done before considering it an indispensable instrument to achieve a fast and safe TLH. Unfortunately, data
about a direct comparison of ureteral and bladder injuries
rate in TLH with or without manipulator are not available,
impeding to achieve conclusions about the actual safety
and effectiveness of uterine manipulators. Noteworthy, this
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discussion is primary related to conditions without abnormal
anatomy, such in case of deep infiltrating endometriosis, that
can involve the ureter increasing the risk of injuries during
surgical procedures that require TLH [54–56]. Laparoscopic
surgery for endometriosis can be extensive, involving different pelvic structures and organs, and the management
of adhesions and nodules is facilitated by a third assistant
applying a traction with the uterine manipulator on uterus
and uterine ligaments [57–60].
Operative time represents a further parameter influencing the choice of a surgical approach, and a difference in
the operating time between TLH with or without a uterine
manipulator is reported in some studies. The reason of the
longer operative time for TLH without a uterine manipulator is thought to be related to the complexity of the case
rather than the absence of the manipulator. A study comparing TLH without manipulator for uteri of above or below
280 g found that the time difference (112 min versus 91 min
respectively) is the time needed for morcellation [33]. At the
same time, another study found a longer operative time for
procedures performed with a manipulator (83 min versus
133 min), independent of other surgical characteristics that
could be explained by the time needed to place the uterine
manipulator [33]. Nevertheless, definitive conclusion is not
achievable due to the limited body of evidence that, in general, suggests comparable operative times.
Another variable that can affect the choice of the surgical
approach is the learning curve. Intensified training of the
surgeon and acquired experience can decrease the operative time, as well as perioperative complications [30, 31].
Evidence suggests that the learning curve of TLH without
a uterine manipulator seems to be shorter or comparable to
those for TLH with uterine manipulator. However, with a
uterine manipulator not only the surgeon requires skills and
experience to perform a TLH, but also the entire operating
team should be skillful, especially the assistant who will be
in charge of manipulating the uterus. Therefore, the learning
curve of the assistant could be considered a disadvantage
that can be spared in TLH without a manipulator [9].
Finally, although performing a cost analysis of uterine
manipulators is difficult to be performed, the uterine manipulator is estimated to be the 8% of the total cost and its cost
effectiveness is still not proved [16]. Consequently, TLH
without a uterine manipulator may be a way of cost saving.
Of note, in some conditions, the choice is not possible.
Although the evidence is not enough to conclude about the
advantages and disadvantages of the uterine manipulators
use compare to the no use, in some patients, anatomical reasons impede the use of uterine manipulator. In patients with
vaginal stenosis or other situations making difficult the identification of the cervix (a case of a voluminous fibroma or
mass bulging into the vagina) [2], the possibility to perform
hysterectomy by laparoscopy should still be offered, and
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this can be accomplished without the use of a manipulator.
Meanwhile, new techniques of TLH are being described only
with the use of uterine manipulator. A case report of TLH
without general anesthesia is published in the literature.
The TLH was performed under regional anesthesia, with
an 8-mmHg pneumoperitoneum maintained by the Gomes
da Silveira uterine manipulator, and authors highlighted the
importance of an adequate uterine manipulator to achieve
this particular type of innovating surgery [26]. No TLH
without manipulator under spinal anesthesia is performed
to date, so no evidence exists on its feasibility under low
abdominal pressure.
Conclusion
Since its beginning, TLH was associated with the use of a
uterine manipulator to facilitate anatomical exposure and
uterine mobilization. Nevertheless, different complications associated with uterine manipulators were described
and clinical evidence regarding their efficacy and safety
are limited, first of all, because the body of evidence about
a comparison with the TLH performed without a uterine
manipulator is limited. This alternative technique seems to
be equivalent to the original method in terms of operative
time and learning curve, with the avoidance of complications
related to manipulator usage. Nevertheless, further studies
are required to further address the real effectiveness of uterine manipulators during TLH compared to the no use. Particularly, because a direct comparison of the urinary injuries
rate between the two approaches is not available. Therefore,
further studies are necessary.
Meanwhile, the individualized approach for each case is
mandatory with the choice to use or not the manipulator and
which manipulator to use that should be made according to
the needs of the case. Indeed, uterine manipulator can provide support in cases of large uteri, severe endometriosis,
recto vaginal adhesions and regional anesthesia, while its
use might increase complications in case of vaginal stenosis
and nulliparity.
Funding The work was not supported by any grant.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
Research involving human participants and/or animals The paper is
a review research and does not include any intervention with human
participants or animals.
Informed consent For this type of study, formal consent is not required.
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