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Original Article
Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus
10-mm Laparoscope: A Randomized Control Trial
Jade N. Acton, MBBS, MRANZCOG*, Stuart G. Salfinger, MBBS, FRANZCOG, CGO,
Jason Tan, MBBS, FRANZCOG, CGO, and Paul A. Cohen, BM BCh, MA, FRANZCOG, MD
From the Department of Endoscopy, King Edward Memorial Hospital, Perth, Western Australia, Australia (Dr. Acton), and Department of Gynaecologic
Oncology, St. John of God Hospital Subiaco, University of Western Australia, Perth, Western Australia, Australia (Drs. Salfinger, Tan, and Cohen).
ABSTRACT Study Objective: To determine if the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of
earlier discharge from hospital after total laparoscopic hysterectomy (TLH) compared with a 10-mm umbilical incision and
laparoscope. Secondary objectives of the study were to determine if the use of a 5-mm laparoscope would lead to a reduction
in postoperative pain scores and a shorter operating time without an increase in complication rates.
Design: Prospective, randomized, double-blinded, clinical trial (Canadian Task Force classification I).
Setting: A tertiary care setting.
Patients: Seventy-eight patients scheduled for TLH were prospectively recruited.
Interventions: Women undergoing TLH were assigned to either a 5-mm umbilical port and laparoscope (5LH) or a 10-mm
umbilical port and laparoscope (10LH). All patients underwent a standardized operative technique and anesthetic protocol.
Patients and research assistants responsible for postoperative pain assessment were blinded to group. Analysis was by intention-to-treat.
Measurements and Main Results: The primary outcome measure was length of hospital stay. Secondary outcome measures
were operating time, pain scores on postoperative days 1 and 7, and complication rates. There was no difference in length of
hospital stay between the 2 arms. Compared with the 10LH group, the 5LH group had shorter operative times (32.6 vs 40
minutes; p 5 .01) and less postoperative pain on day 1 (2.5 vs 3.3; p 5 .03 for ‘‘pain with movement’’) and on day 7
(.92 vs 1.8; p 5 .002). Complication rates were similar between the 2 groups.
Conclusion: TLH with a 5-mm laparoscope resulted in shorter operative times and less pain on postoperative days 1 and
7, compared with a 10-mm laparoscope, with similar length of stay and complications. Journal of Minimally Invasive Gynecology (2016) 23, 101–106 Crown Copyright Ó 2016 Published by Elsevier Inc. All rights reserved.
Keywords:
DISCUSS
Laparoscopic hysterectomy; Laparoscopy/methods; Mini-laparoscopy; Pain; Port size
You can discuss this article with its authors and with other AAGL members at http://
www.AAGL.org/jmig-22-6-JMIG-D-15-00344.
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Hysterectomy is the most common gynecologic surgical
procedure performed in reproductive-aged women. Every
year more than 500 000 hysterectomies are performed in
There was no funding for this research. Drs. Salfinger and Tan are paid consultants for teaching purposes by Covidien Health Care. Drs. Acton and Cohen report no conflicts of interest.
Corresponding author: Dr. Jade N. Acton, MBBS, MRANZCOG, King
Edward Memorial Hospital, PO Box 1617, Subiaco, WA, Australia, 6904.
E-mail: [email protected]
Submitted June 5, 2015. Accepted for publication September 1, 2015.
Available at www.sciencedirect.com and www.jmig.org
the United States [1] and approximately 30 000 in Australia
[2]. Compared with abdominal hysterectomy, the advantages
of a laparoscopic approach include decreased postoperative
intravenous analgesia requirements, shorter length of hospital stay, enhanced time to recovery, and faster return to work
and daily activities [1]. Longer operating times have been
shown to be offset by shorter hospital stays, with similar hospital costs overall [1].
As minimally invasive surgical techniques have evolved,
there has been considerable interest in further minimizing
the ‘‘invasiveness’’ of procedures. By decreasing the number
and/or size of the operating ports and surgical instruments,
1553-4650/$ - see front matter Crown Copyright Ó 2016 Published by Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.jmig.2015.09.001
102
it is hoped that patient outcomes will improve further.
Advances in the manufacture of surgical equipment and
fiberoptic technology have led to the development of smaller
caliber instruments and improved optics and light sources
and the emergence of the concept of ‘‘mini-laparoscopy’’
[3].
Although internationally there has been a trend toward
smaller incisions and surgical instruments, research has
tended to focus on a reduction in size of the ancillary ports
but not the primary port. Several studies in the gynecologic
and general surgical literature have shown that minilaparoscopic instruments offer safe alternatives to conventional laparoscopy but have thus far failed to demonstrate
a significant decrease in postoperative pain scores [3,4].
We hypothesize that this failure to show improvements in
postoperative pain scores after mini-laparoscopy may be
attributable to the larger diameter of the primary port used
for the laparoscope.
The use of a 10-mm transumbilical laparoscope for minimally invasive hysterectomy has been standard practice
among laparoscopic gynecologic surgeons in Western
Australia. Despite their widespread availability, 5-mm laparoscopes are not routinely used because of a perception that
the image quality and definition are inferior compared with
10-mm laparoscopes. We have previously demonstrated that
the use of a 5-mm umbilical port resulted in a higher proportion of patients being discharged home after total laparoscopic hysterectomy (TLH) on the first postoperative day
compared with patients whose procedure was performed
using a 10-mm umbilical port [5]. This was, however, a
retrospective analysis and hence subject to potential sources
of bias.
Our hypothesis was that the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of
earlier discharge from hospital after TLH compared with a
10-mm umbilical incision and laparoscope. We also hypothesized that the use of a 5-mm laparoscope would lead to a
reduction in postoperative pain scores and a shorter operating time without an increase in complication rates.
Methods
In this prospective randomized trial, patients were recruited between July 1, 2013 and February 28, 2014. There
were no changes to the study methodology after trial
commencement. Women who were scheduled to undergo a
TLH were eligible to participate in the study and were
enrolled by one of the authors (S.S. or J.T.). Indications for
hysterectomy were early-stage endometrial cancer, microinvasive cervical cancer requiring simple extrafascial hysterectomy, prophylactic risk reduction surgery, complex
adnexal masses not deemed to be high risk for malignancy,
and dysfunctional uterine bleeding. Exclusion criteria were
the need for comprehensive surgical staging of malignant
disease, a previous midline laparotomy, and suspected or
known severe endometriosis. The trial was conducted in
Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016
the Department of Gynecologic Oncology at St. John of
God Hospital, Subiaco, Western Australia.
Our primary outcome measure was length of hospital
stay. Secondary outcome measures included pain scores on
postoperative days 1 and day 7, operating time, and complication rates.
The study sample size was based on detecting a clinically
significant reduction in length of hospital stay when the 5mm umbilical port technique was used. Previously published
institutional data showed a reduction in length of hospital
stay for 5-mm umbilical incisions (38% discharged on day
1; mean length of stay, 1.9 days) when compared with 10mm umbilical incisions (3% discharged day 1; mean length
of stay, 3.05 days) [5]. A priori calculations showed a
required sample size of 32 patients per trial arm
to demonstrate a 30% increase in the discharge rate on day
1 at alpha 5 .05 for 80% power.
Patients were randomly assigned to undergo TLH using
either a 1-0 mm umbilical incision and laparoscope
(10-mm laparoscopic hysterectomy [10LH]) or a 5-mm umbilical incision and laparoscope (5-mm laparoscopic hysterectomy [5LH]). The ancillary ports in both treatment groups
were 5 mm in diameter. Randomization was performed on
the basis of a block-randomization computer-generated
list, with a block size of 6.
The surgeon was notified of the allocation in the operating theatre on the morning of the procedure. Patients
were blinded to their randomization. The study protocol
was approved by the Human Research Ethics Committee
at St. John of God Hospital, Subiaco (reference no. 607)
and registered with the Australian and New Zealand Clinical
Trial Registry (clinical trial no. ACTRN12613000696796).
Patients underwent a standardized anesthesia protocol,
including induction with propofol (2–3 mg/kg) and fentanyl
(1.5 mg/kg), neuromuscular blockade with rocuronium (.5
mg/kg), and maintenance with sevoflurane (.7–2.0% endotracheal concentration) and fentanyl. Increases in blood
pressure or heart rate were treated by additional doses of fentanyl (50–100 mg) as required and at discretion of the anesthetist. Dexamethasone 4 mg was given for prophylaxis of
postoperative nausea and vomiting. Postoperatively, patients
were initially managed with a fentanyl protocol in recovery
(20-mg boluses, every 5 minutes as required until discharge
from recovery) and regular paracetamol and celocoxib
with oxycodone and tramadol as required.
Surgery was performed by 1 of 2 gynecologic oncologists
(S.S. or J.T.), who had both undertaken laparoscopic fellowships before gynecologic oncology subspecialty training.
The same surgical technique was used for both 10LH and
5LH. Instrumentation included graspers, scissors, monopolar electrocautery, and a suction-washing system. Tissue
dissection and coagulation was performed with a Ligasure
5-mm device (Covidien, Mansfield, MA). The surgical technique is described in Appendix A.
The rectus sheath in patients randomized to the 10LH arm
was closed using an interrupted 1.0 synthetic absorbable
Acton et al.
Outcomes of TLH Using 5-mm vs 10-mm Laparoscope
suture (Polysorb; Covidien, Mansfield, MA). The rectus
sheath in patients randomized to the 5LH arm was not
closed. All skin incisions were closed subcutaneously with
a 3.0 synthetic absorbable suture (Caprosyn; Covidien,
Mansfield, MA).
Patients, research assistants, and nursing staff responsible for pain assessment and recording pain scores
were blinded to which group randomization had occurred,
and the patients’ wounds were concealed by standard-size
nontransparent dressings. The blinded research assistants
assessed patients each day for discharge, and the
discharge time was recorded. Postoperative pain was rated
on day 1, at rest, on movement, and at the umbilicus and
on day 7 using a 100-mm visual analogue scale with anchors of no pain and worst possible pain. Quality of life
was measured at 6 weeks using an EQ-5D-5L quality of
life instrument (Appendix B).
Intraoperative complications were defined as any event
that required additional surgical procedures to be performed,
including repair of iatrogenic visceral injury and hemorrhage requiring blood transfusion. Postoperative complications included febrile episode, urinary voiding difficulties
or urinary tract infection, wound infection, vault hematoma,
venous thrombosis, sepsis, return to the operating room, and
hospital readmission after discharge.
Fig. 1
Flow of participants through the randomized clinical trial.
103
Statistical analysis of outcomes data was performed with
GraphPad (GraphPad Software, San Diego, CA). A 2-sided
paired t test was used to compare continuous variables.
Fisher’s exact test was used to analyze proportions. Results
were analyzed by intention-to-treat.
Results
Seventy-eight patients were enrolled in the study. Forty
women were randomly assigned to the 10LH group and 38
to the 5LH group. Two patients were excluded from the
5LH group because of breaches in the anesthetic protocol.
Flow of participants through the randomized clinical
trial is displayed in Figure1. No patients were lost to
follow-up. The demographics and baseline characteristics
of the participants were comparable between groups
(Table 1). The procedures in both groups were distributed
evenly between both operating physicians.
Perioperative outcomes are summarized in Table 2.
The 2 groups had comparable uterine size, adhesions,
and estimated blood loss. There were no intraoperative
complications or conversions to laparotomy in either
group. The operating time (taken as the time from the first
skin incision to closure of the final skin incision) in the
5LH group was nearly 8 minutes shorter than in the
104
Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016
Table 1
Table 3
Baseline characteristics
Discharge time
5LH group
(n 5 36)
10LH group
(n 5 40)
Median age, yr (range)
51.5 (32–83)
54 (35–77)
26.9 (19–40) 27.0 (20–39)
BMI, kg/m2
Obese (BMI . 30)
13 (36%)
10 (25%)
Menopause
19 (52%)
23 (58%)
Parity (range)
2 (0–4)
2 (0–4)
Previous abdominal surgery
17 (47%)
12 (30%)
Previous cesarean section
9 (25%)
6 (15%)
Indication for surgery
DUB
8 (22%)
5 (12.5%)
Early endometrial cancer
8 (22%)
8 (20%)
High-grade cervical dysplasia
4 (11%)
4 (10%)
Adnexal disease
4 (11%)
8 (20%)
Risk reduction
12 (33%)
15 (37.5%)
p
.92
.51
.39
.68
.31
.12
.28
.40
5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy; BMI 5 body mass index; DUB 5 dysfunctional uterine bleeding.
10LH group (32.6 vs 40 minutes; p 5 .01). No patients in
the 5LH group required conversion of their 5-mm umbilical port to a larger port to facilitate completion of the
procedure. There were no intraoperative complications
in either group and no statistical difference in postoperative complications.
Length of hospital stay is shown in Table 3. There was no
significant difference between the 2 groups in the proportion
10LH group
(n 5 40)
p
24 (67%)
1.36 6 .53
24 (60%)
1.425 6 .54
.55
.61
34 (22–48)
34.6 (20–70)
.81
5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy.
of patients discharged on the first postoperative day or in the
length of hospital stay.
Pain scores recorded in each group are shown in Table 4.
There was a significant reduction in postoperative pain on
movement on day 1 (2.5 vs 3.3; p 5 .03) in the 5LH group
but no difference in pain at rest or pain localized at the
umbilicus. There was a significantly lower pain score on
day 7 in patients in the 5LH group (.92 vs 1.8; p 5 .002)
compared with patients in the 10LH group. There was no difference between the 2 groups in the overall quality of life
score or the individual components of the quality of life instrument at 6 weeks.
Discussion
Main Findings
In this double-blind, randomized, controlled trial of the
use of a 5-mm versus 10-mm laparoscope for TLH, there
Table 2
Perioperative outcomes
Operative time, min
Procedure performed
TLH
TLH 1 USO
TLH 1 BSO
Uterine weight, g (range)
Adhesiolysis/uterine
debulking required
Intraoperative complications
Estimated blood loss, mL
(range)
Postoperative complications
No. discharged by 24 hr
Mean discharge day average 6
standard deviation
Median discharge hours
postoperative (range)
5LH group
(n 5 36)
Table 4
Pain scores and quality of life
5LH group
(n 5 36)
10LH group
(n 5 40)
32.6 6 10.2
40 6 13.54
11
1
24
117.5 (57–680)
8 (22%)
11
0
29
118 (70–487)
8 (20%)
.76
.86
0
42 (0–100)
0
50 (25–100)
.13
3 (8%)*
4 (10%)y
.88
p
.01
.98
Day 1 pain score
Rest
Movement
Umbilicus
Day 7 pain score
Quality of life (/100)
Mobility*
Personal care*
Usual activities*
Pain/discomforty
Anxiety/depressiony
5LH group
(n 5 36)
10LH group
(n 5 40)
p
1.77 6 1.77
2.5 6 1.62
.92 6 1.72
.92 6 1.72
85.1 6 11.2
1.06 6 .32
160
1.08 6 .27
1.17 6 .37
1.11 6 .46
1.95 6 1.93
3.33 6 1.67
.625 6 .86
1.8 6 1.32
85.2 6 9.52
1.03 6 .15
160
160
1.1 6 .3
1.05 6 .22
.68
.03
.35
.002
.97
.61
1
.06
.40
.45
5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic
hysterectomy; TLH 5 total laparoscopic hysterectomy; USO 5 unilateral
salpingo-oopherectomy; BSO 5 bilateral salpingo-oopherectomy.
5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy.
Values are means 6 standard deviations, medians with ranges in parentheses, or
number of cases with percents in parentheses.
* Two vault hematomas, 1 wound infection.
y
Four vault hematomas.
Values are means 6 standard deviations.
* Scale: 1 5 no problems, 2 5 slight problems, 3 5 moderate problems, 4 5
severe problems, 5 5 unable to perform.
y
Scale: 1 5 nil, 2 5 slight, 3 5 moderate, 4 5 severe, 5 5 extreme.
Acton et al.
Outcomes of TLH Using 5-mm vs 10-mm Laparoscope
was no difference in length hospital of stay or complication
rates between the 2 groups. Patients in the 5LH group had
shorter operative times and less pain on postoperative days
1 and 7.
Our findings differ from an earlier retrospective study
conducted at our institution that showed a significantly
longer length of hospital stay in patients whose TLH was
performed using a 10-mm laparoscope (3.05 days for 10mm umbilical incision in the earlier study vs 1.43 days for
the 10-mm port in this trial) [5]. It is conceivable that selection bias inherent in retrospective observational studies may
account for the observed difference in outcomes compared
with the current trial.
Strengths and Limitations
The strengths of our study are its prospective, randomized
participant and research assistant blinded design. Discharge
times are difficult to accurately capture, and it has been
shown that these are influenced by multiple factors,
including availability of an escort, nursing shortages, and
delays in supplying discharge medications [6]. It is conceivable that some of these factors may have confounded our
results.
Our study has several limitations. Capturing the return of
postoperative patients to their normal activities as well as
measuring the postoperative use of analgesia may have
added important clinical information, and it is a weakness
of our study that these were not included. Participants’
comorbidities, including preoperative chronic pain, substance abuse, or potentially pain-modifying diseases such
as diabetes mellitus with microvascular complications or
peripheral neuropathy, were not recorded, and this may
have confounded our results. Our study is also limited by
its relatively small sample size.
Interpretation (in Light of Other Evidence)
Previous studies have examined the effects on pain scores
of using smaller size ancillary ports, but the results of these
studies have been conflicting [3,4,7–9]. Only 1 other
randomized trial has compared mini-laparoscopic total
hysterectomy with conventional TLH [3]. In this study by
Ghezzi et al [3], 76 women were randomized to either
mini-laparoscopic hysterectomy or to conventional laparoscopic hysterectomy for the treatment of presumed benign
pathology at a single tertiary hospital. The primary outcomes
were postoperative pain at 1, 3, 8, and 24 hours, and there
was no significant difference in outcomes between the
2 treatment groups. Secondary outcomes included length
of hospital stay, estimated blood loss, and decrease in hemoglobin concentration, all of which did not differ between the
2 treatment arms. However, the authors were comparing the
use of 5-mm umbilical and ancillary ports (conventional
laparoscopic hysterectomy) with 3-mm umbilical and ancillary ports (mini-laparoscopic hysterectomy), which may
105
account for the observed similarities in postoperative pain
scores between the 2 treatment arms and for the difference
in outcomes observed in our study.
In the general surgical literature, results of randomized
trials comparing the use of 3-mm or 5-mm ports and instruments with standard laparoscopic procedures have been
conflicting. Although some have shown decreased postoperative pain [7–9], others have failed to show any significant
differences in postoperative pain, length of hospital stay,
or recovery time [10,11]. Other studies have demonstrated
that reducing the size or even number of ports in a
laparoscopic cholecystectomy significantly reduced
postoperative pain [7,8].
It is difficult to compare results from general surgical
trials to gynecologic laparoscopy studies for 2 reasons.
First, many of these studies used at least one 10-mm or
12-mm port with smaller ancillary ports, and the larger
incision may have influenced the postoperative pain scores.
Second, in laparoscopic cholecystectomies or appendectomies the specimens are removed through 1 of the abdominal port sites, which may exacerbate postoperative pain at
that site.
Although we have demonstrated a significant reduction
in postoperative pain with the use of a 5-mm umbilical
port, it is uncertain whether this difference is clinically
meaningful because the pain scores in both treatment
groups were low and there was no difference in length
of hospital stay between the 2 study arms. The increased
pain score on movement in the 10LH group may be attributable to the rectus sheath suture, although pain at the
umbilicus did not differ between the 2 groups. It is also
conceivable that confounding factors such as differences
in postoperative analgesia or pre-existing comorbidities
between the study arms may have accounted for these
findings.
This rectus sheath suture is clinically important to reduce
the risk of hernia formation [12]. A survey by the American
Association of Gynecologic Laparoscopists demonstrated
that 86.3% of all trocar site hernias occurred in sites where
the ports were at least 10 mm [12]. Studies have shown
that the closure of a fascial defect because of a 12-mm trocar
significantly decreased the rate of developing a hernia at the
site (.22%), when compared with leaving it open (8%) [13].
The incidence of herniation through a 5-mm port is much
lower, comprising only 2.7% of all trocar site hernias, and
thus closure is not routinely recommended [13,14]. Our
study was not powered to detect a decrease in umbilical
hernias between the 2 treatment groups, and this is an
important area for future research.
We have also demonstrated a significant difference in
the operating time, with procedures in the 5LH group being
an average of 7.4 minutes faster than those in the 10LH
group. This may be due to the additional time required to
close the umbilical port in the 10LH group. However, it
is possible that other patient-specific or operating room factors may have accounted for part of the observed difference
106
Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016
in operating times. The reduced operating time in the 5LH
group may have significant benefits for operating theatre
utility, especially when several TLHs are scheduled on
the same operating list and may have significant cost
benefits.
Conclusion
In summary, in this blinded, randomized, controlled trial
comparing the use of a 5-mm versus 10-mm umbilical port
and scope for laparoscopic hysterectomy, we found that
the 5LH group had shorter operative times and a decrease
in pain on postoperative days 1 and 7, with similar length
of stay and complications. It is not clear if the observed difference in pain scores is clinically meaningful because the
pain scores in both treatment groups were low and there
was no difference in length of hospital stay between the 2
study arms. Our findings suggest that concerns about poor
visualization with a 5-mm endoscope may be unfounded
and that laparoscopic hysterectomy with a 5-mm scope is
feasible with equivalent outcomes.
Supplementary Data
Supplementary data related to this article can be found at
10.1016/j.jmig.2015.09.001.
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