Original Article

Safety of Laparoscopic Surgery for Benign Diseases during

Pregnancy: A Nationwide Retrospective Cohort Study
D1X XDaisuke Shigemi, D2X XMD, MPH, D3X XShotaro Aso, D4X XMD, MPH, D5X XHiroki Matsui, D6X XPT, MPH,
D7X XKiyohide Fushimi, D8X XMD, PhD, and D9X XHideo Yasunaga, D10X XMD, PhD
From the Department of Clinical Epidemiology and Health Economics (Drs. Shigemi, Aso, Matsui, and Yasunaga), School of Public Health, The University of
Tokyo, Tokyo, Japan, and Department of Health Policy and Informatics (Dr. Fushimi), Tokyo Medical and Dental University Graduate School, Tokyo, Japan.

TAGEDPABSTRACT Study Objective: To compare fetal, maternal, and operative outcomes of laparoscopic surgery versus laparotomy for major
benign diseases including appendicitis, cholecystitis, adnexal masses, and uterine myoma during pregnancy.
Design: Retrospective cohort study (Canadian Task Force classification II-2).
Setting: The Diagnosis Procedure Combination database, a national inpatient database for acute care inpatients in Japan.
Patients: Eligible patients (n = 6018) underwent abdominal surgery (4047 laparotomy and 1971 laparoscopy patients) from
July 2010 through March 2016.
Interventions: The 2 groups were compared using propensity score matching analysis.
Measurements and Main Results: The primary outcome was fetal adverse events, including abortion or stillbirth within
7 days after surgery and premature delivery during hospitalization. Secondary outcomes were operative time, blood transfu-
sion, and length of hospital stay after surgery. Propensity score matching created 740 pairs. Significant difference was
observed in the primary outcome between propensity score matched patients in the laparotomy versus laparoscopy group
(1.8% vs .41%, respectively; risk difference, ¡1.4%; 95% confidence interval, ¡2.4 to ¡.30; p = .01). Compared with the
laparotomy group, the laparoscopy group had a significantly lower incidence of blood transfusion (2.3% vs .41%, p = .002),
shorter operative time (115 vs 95 minutes, p <.001), and shorter hospital stay (9.2 vs 5.9 days, p <.001).
Conclusion: Our current study using propensity score matching suggests the advantages of laparoscopic surgery for
benign diseases compared with laparotomy because laparoscopic surgery had advantages in short-term fetal adverse
events, incidence of blood transfusion, operative time, and hospital stay. Journal of Minimally Invasive Gynecology
(2018) 00, 1 6 © 2018 AAGL. All rights reserved.
Keywords: Adnexal mass resection; Appendectomy; Cholecystectomy; Laparoscopy; Pregnancy; Uterine myomectomy

Laparoscopic surgery during pregnancy has become
widely used in various fields; however, open surgery is still
performed because of the potential risks of laparoscopic
surgery for pregnant women and fetuses. Systematic
Dr. Yasunaga received grants from the Ministry of Health, Labour and
Welfare, Japan (H29-Policy-Designated-009 and H29-ICT-Genral-004);
Ministry of Education, Culture, Sports, Science and Technology, Japan
(17H04141); and the Japan Agency for Medical Research and Develop-
ment (15lk1110001h0001). Dr. Fushimi received a grant from the Ministry
of Health, Labour and Welfare, Japan (H29-Policy-Designated-009). The
funding organizations had no role in planning research, analysis, interpre-
tation of results, or report writing.
Corresponding author: Daisuke Shigemi, MD, MPH, Department of Clini-
cal Epidemiology and Health Economics, School of Public Health, The
University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 1130033, Japan.
E-mail: dshigemi@m.u-tokyo.ac.jp
Submitted April 25, 2018, Accepted for publication June 8, 2018.
Available at www.sciencedirect.com and www.jmig.org
1553-4650/$ — see front matter © 2018 AAGL. All rights reserved.
https://doi.org/10.1016/j.jmig.2018.06.008
reviews and meta-analyses have confirmed the advantages
of laparoscopic surgery in pregnant women [1 6]. The
Society of American Gastrointestinal and Endoscopic Sur-
geons guideline has been widely used in surgery during
pregnancy [7].
However, most previous studies analyzed only a small
number of pregnant patients, and each study reported on a
specific disease, such as appendicitis [5,6], adnexal masses
[1,3,4], or gallbladder disease [2]. Recent reviews and a
meta-analysis on adnexal masses included no more than
500 to 600 patients [1,4]; the Cochrane Library in 2013
reported no randomized controlled trials on the subject
since 2006 [3]. A systematic review and meta analysis on
appendectomy in pregnancy analyzed 3415 patients; how-
ever, only 599 of the patients underwent laparoscopic sur-
gery [5]. The aim of the current study was to compare
maternal, fetal, and operative outcomes after laparoscopy
versus laparotomy for appendicitis, cholecystitis, uterine
2 Journal of Minimally Invasive Gynecology. Vol 00, No 00, 2018
myoma, and adnexal masses during pregnancy, using a
nationwide Japanese inpatient database.
Methods
In this retrospective cohort study, we used the Diagnosis
Procedure Combination database, a national inpatient data-
base for acute care inpatients in Japan, the details of which
have been described elsewhere [8]. The database was estab-
lished in 2003 with 82 academic hospitals; the number of
participating hospitals has gradually increased since that
time. As of 2016 more than 1000 hospitals, including all 82
academic hospitals and more than 90% of all tertiary emer-
gency centers, had adopted the database. Because the Diag-
nosis Procedure Combination participating hospitals are
generally large facilities, the number of included patients
was approximately 7 million in 2016, representing approxi-
mately 50% of all patients admitted to hospitals in Japan.
Attending physicians are required to record disease diagno-
ses accurately because the diagnostic records are linked to
a payment system that is based on medical insurance. A
previous study showed that the validity of diagnostic
records in the Diagnosis Procedure Combination database
was generally high. The sensitivity and specificity of the
primary diagnoses were 78.9% and 93.2%, respectively [9].
The database includes the following data: dates of admis-
sion and discharge, patient age and sex, body weight and
height, primary and secondary diagnoses, pre-existing
comorbidities at admission and complications after admis-
sion, procedures performed, medications and devices used,
in-hospital mortality, pregnancy status (pregnant or not),
gestational age at admission, and delivery during hospitali-
zation. Diagnoses, comorbidities, and complications are
recorded using the codes of the International Classification
of Diseases, Tenth Revision; text data are in Japanese. The
database does not contain any laboratory data or obstetric
examination findings (including Bishop score, uterine cer-
vical length, or vaginal bacteriologic culture).
We identified pregnant women aged 13 to 53 years with
complete data who underwent abdominal surgery before 37
weeks of gestation and who were admitted to the hospital
from July 2010 to March 2016. Patients who underwent
abdominal surgery at the time of cesarean delivery were
not included. In this study abdominal surgeries (by laparos-
copy or laparotomy) included 4 operative procedures for
benign diseases: appendectomy, cholecystectomy, uterine
myomectomy, and adnexal mass resection.
Patient age was categorized as 19, 20 to 29, 30 to 39,
or 40 years. Body mass index (BMI) was not classified
according to the World Health Organization classification
because all patients in the current study were pregnant. Ges-
tational age at surgery was categorized as 14, 15 to 27, or
28 to 36 weeks.
Exclusion criteria included multiple pregnancy, ectopic
pregnancy, and impaired consciousness at admission.
The primary outcome was fetal adverse events, includ-
ing abortion or stillbirth within 7 days after surgery and pre-
mature delivery (<37 weeks’ gestation) during
hospitalization. Secondary outcomes were operative and
maternal outcomes, including operative time, blood transfu-
sion, and length of hospital stay after surgery. In addition,
major operative complications, including bowel injury
(International Classification of Diseases, Tenth Revision:
S367, S369), bladder injury (S372, S371), and pulmonary
thromboembolism (I269), were evaluated.
Categorical variables (age, gestational age at surgery,
smoking, operative procedure, general anesthesia, emergent
maternal transport, and emergent surgery within 2 days of
admission) were compared with the x2 or Fisher’s exact
test. The average proportion of surgeries performed lapa-
roscopically at each hospital and BMI were compared
between the laparotomy and laparoscopy groups with a t
test.
We conducted propensity score matching between the
laparotomy and laparoscopy groups [10]. We estimated
the propensity scores with a logistic regression model for
the likelihood of laparoscopy as a function of the follow-
ing parameters: age, BMI, gestational age at surgery,
smoking, operative procedure, emergent maternal trans-
port, emergent surgery within 2 days of admission, and
the average ratio of laparoscopies to laparotomies per-
formed at each hospital.
The C-statistic was calculated with the area under the
receiver operating characteristic curve to evaluate the
model predicting the receipt of laparoscopic surgery. We
performed 1-to-1 propensity score matched analysis using
nearest neighbor matching without replacement within a
caliper of .25 standard deviations of pooled propensity
scores [11].
After matching, we assessed the balance of baseline var-
iables in the matched patient groups with the standardized
difference. An absolute standardized difference > 10%
indicated a meaningful imbalance [12].
We compared outcomes between the laparotomy and
laparoscopy groups with the x2 test. We estimated risk dif-
ferences and 95% confidence intervals for the primary out-
come and 3 secondary outcomes.
All statistical analyses were performed with Stata soft-
ware version 15.0 (StataCorp LP, College Station, TX). All
tests were 2-tailed, and the threshold for significance was
p <.05.
Written informed consent was not required because of
the anonymous nature of the data. The need for written con-
sent was formally waived by the ethics committee. The
Institutional Review Board at The University of Tokyo
approved the study.
Results
We identified 9065 patients who underwent abdominal
surgery during pregnancy in the study period. A total of
Shigemi et al. Safety of Laparoscopic Surgery in Pregnancy 3

Fig. 1
Study flow diagram showing the stratification and selection of pregnant patients in the Diagnosis Procedure Combination database who underwent
abdominal surgery from 2010 to 2016.

6018 eligible patients were selected, including 4047 lapa- Table 1 shows the baseline patient characteristics in the
rotomy patients and 1971 laparoscopy patients. Propensity unmatched and propensity score matched groups. In the
score matching created 740 pairs (Fig. 1). The C-statistic of unmatched groups the laparotomy group was significantly
the model for calculating propensity scores was .90. more likely to have emergent maternal transport and

Table 1
Baseline patient characteristics in unmatched and propensity score matched groups

Unmatched groups Propensity score matched groups

Laparotomy Laparoscopy ASD Laparotomy Laparoscopy ASD
(n = 4,047) (n = 1,971) (%) (n = 740) (n = 740) (%)
Age, yr
19 77 (1.9) 45 (2.3) 2.8 17 (2.3) 17 (2.3) 0
20 29 1690 (41.8) 888 (45.1) 6.7 325 (43.9) 332 (44.9) 2.0
30 39 2103 (52.0) 970 (49.2) 5.6 369 (49.9) 361 (48.8) 2.2
40 177 (4.4) 68 (3.5) 4.6 29 (3.9) 30 (4.1) 3.3
Mean BMI, kg/m2 (SD) 21.8 (9.0) 21.5 (3.2) 7.9 21.6 (3.8) 21.6 (3.2) 1.7
GA, wk
14 1713 (42.3) 555 (28.2) 29.8 314 (42.4) 331 (44.7) 4.6
15 27 2109 (52.1) 1384 (70.2) 37.8 397 (53.7) 382 (51.6) 4.2
28 36 225 (5.6) 32 (1.6) 21.6 29 (3.9) 27 (3.7) 1.0
Smoking 440 (10.9) 251 (12.7) 5.6 82 (11.1) 88 (11.9) 2.5
Emergent maternal transport 464 (11.5) 162 (8.2) 11.1 78 (10.5) 83 (11.2) 2.3
Surgery within 2 days of admission 1235 (30.5) 463 (23.5) 15.8 195 (26.4) 215 (29.1) 6.0
General anesthesia 1222 (30.2) 1773 (90.0) 154.2 560 (75.7) 545 (73.7) 4.6
Proportion of surgeries performed laparoscopically at hospital .49 .75 108.2 .66 .64 9.5
Operative procedure
Appendectomy 674 (16.7) 149 (7.6) 28.1 97 (13.1) 107 (14.5) 4.1
Cholecystectomy 11 (.3) 70 (3.6) 24.0 5 (.7) 9 (1.2) 5.2
Uterine myomectomy 180 (4.5) 8 (.4) 26.8 6 (.8) 8 (1.1) 3.1
Adnexal mass resection 3182 (78.6) 1744 (88.5) 26.9 632 (85.4) 616 (83.2) 6.1

ASD = absolute standardized difference; GA = gestational age at surgery; SD = standard deviation.

Values are n (%) unless otherwise defined.
4 Journal of Minimally Invasive Gynecology. Vol 00, No 00, 2018
Table 2
Incidence of primary outcome in unmatched and propensity score matched laparotomy and laparoscopy groups
Laparotomy
Unmatched groups 53/4047 (1.3%)
Propensity score matched groups 13/740 (1.8%)
Primary outcome is fetal adverse events (abortion or stillbirth within 7 days after surgery and premature delivery).
surgery within 2 days of admission and was less likely to
have general anesthesia than the laparoscopy group. Most
patients in both the laparoscopy and laparotomy groups
underwent surgery in the first or second trimester of preg-
nancy. A higher proportion of laparotomies than laparosco-
pies was performed in the first and third trimesters.
Adnexal mass resection and cholecystectomy were signifi-
cantly more likely to be performed by laparoscopy than
by laparotomy; appendectomy and uterine myomectomy
were significantly more likely to be performed by laparot-
omy. The distributions of the variables in the propensity
score matched groups were well balanced.
There was a significant difference in the primary out-
come (fetal adverse events, including abortion or stillbirth
within 7 days after surgery and premature delivery)
between the laparotomy and laparoscopy groups before
propensity score matching (1.34% vs .36%, respectively;
risk difference, ¡.95%; 95% confidence interval, ¡1.39 to
¡.52). Significant difference was also observed in the pri-
mary outcome between the propensity score matched
groups (1.8% vs .41%, respectively; risk difference,
¡1.4%; 95% confidence interval, ¡2.4 to ¡.30) (Table 2).
Table 3 shows the results of the t test and x2 test for the
secondary outcomes between propensity score matched
groups. Compared with the laparotomy group, the laparos-
copy group had a significantly lower incidence of blood
transfusion (2.3% vs .41%, p = .002), shorter operative time
(115 vs 95 minutes, p <.001), and shorter hospital stay
(9.2 vs 5.9 days, p <.001).
Table 4 shows the primary outcome results stratified
according to gestational age and operative procedure. The
primary outcome was more likely to occur among patients
Table 3
Results of t test and x2 test for secondary outcomes in propensity
score matched groups
Propensity score matched groups
Laparotomy Laparoscopy
(n = 740) (n = 740)
Blood transfusion, n (%) 17 (2.3) 3 (.41)
Operative time, min 114.6 95.4
Length of hospital stay 9.2 5.9
after surgery, days
Laparoscopy Risk difference (%) 95% Confidence interval
7/1971 (.36%) ¡.95 ¡1.39 to ¡.52
3/740 (.41%) ¡1.4 ¡2.4 to ¡.30
who underwent surgery between 28 and 36 weeks’ gesta-
tion than among those who underwent surgery before 28
weeks’ gestation. Among unmatched groups the primary
outcome incidence ranged from 1% to 9% for different pro-
cedures in the laparotomy group and from 0% to 1% for dif-
ferent procedures in laparoscopy group.
Table 5 shows operative times stratified according to
operative procedure. Laparoscopy required shorter opera-
tive time than laparotomy for all procedures. Compared
with appendectomy and adnexal mass resection, cholecys-
tectomy and myomectomy required longer time in the lapa-
rotomy group.
Among the unmatched groups, there was 1 case of bowel
injury and 1 case of bladder injury in the laparoscopy
group. In the laparotomy group there was 1 case of pulmo-
nary thromboembolism. No cases of these operative com-
plications were included in propensity score matched
groups.
Discussion
This study revealed that among 6018 pregnant patients
who underwent abdominal surgery, including appendec-
tomy, cholecystectomy, uterine myomectomy, and adnexal
mass resection, there was a significant difference in the
occurrence of fetal adverse events after laparoscopic sur-
gery versus laparotomy, according to propensity score-
matched analysis. Among propensity score matched
patients, the laparoscopy group had a significantly lower
incidence of blood transfusion, shorter operative time, and
shorter hospital stay compared with the laparotomy group.
Previous meta-analyses and systematic reviews of lapa-
roscopic surgery during pregnancy have included only
small numbers of eligible patients or have contained signifi-
cant biases. A meta analysis of abdominal surgery for sus-
pected adnexal masses reported in 2016 included 4
comparative effectiveness studies, but the study included
only 240 patients [1]. A systematic review and meta anal-
ysis on appendectomy in pregnancy reported in 2012
included 3415 women (599 in the laparoscopic group) [5];
however, 1 of the included studies, which comprised most
p
patients in the review (3133), did not provide information
.002 on anesthesia or gestational age at surgery [13].
<.001 The benefits and drawbacks of laparoscopic surgery for
<.001
pregnant women have been discussed for many years. For
pregnant patients who require abdominal surgery,
Shigemi et al. Safety of Laparoscopic Surgery in Pregnancy 5

Table 4
Results of primary outcome stratified according to gestational age and operative procedure in unmatched and propensity score matched laparotomy
and laparoscopy groups

Unmatched groups Propensity score matched groups

Laparotomy Laparoscopy Laparotomy Laparoscopy
(n = 4047) (n = 1971) (n = 740) (n = 740)
GA, wk
15/1713 1/555 5/314 0/331
14 (.88%) (.18%) (1.6%)
22/2109 4/1384 5/397 1/382
15 27 (1.0%) (.29%) (1.3%) (.26%)
16/225 2/32 1/29 2/27
28 36 (7.1%) (6.3 %) (3.4%) (7.4%)
Operative procedure
8/674 2/149 0/97 2/107
Appendectomy (1.2%) (1.3%) (1.9%)
1/11 0/70 0/5 0/9
Cholecystectomy (9.1%)
6/180 0/8 0/6 0/8
Uterine myomectomy (3.3%)
38/3182 5/1744 11/632 1/616
Adnexal mass resection (1.2%) (.3%) (1.7%) (.2%)

GA = gestational age at surgery.

laparoscopy appears to be associated with less risk than lap-
arotomy [14,15]. The benefits of laparoscopy during preg-
nancy are similar to those in nonpregnant patients. These
include less postoperative pain, less postoperative ileus,
reduced adhesion formation, shorter hospital stay, and
faster return to usual activities [16]. However, these conclu-
sions have been based on studies with small numbers of
patients.
The benefits and drawbacks of laparoscopic surgery for
the fetus have also been frequently discussed. Previous stud-
ies have described laparoscopic procedures in all trimesters
of pregnancy with minimal fetal morbidity; however, no pro-
spective study has evaluated the safety of laparoscopic sur-
gery in human pregnancy. The best available outcome data
are derived from retrospective studies. A retrospective study
from Swedish health registries that included approximately
2100 pregnant patients who underwent laparoscopic surgery
reported no significant differences between the laparoscopy
and laparotomy groups in any measured outcome, including
birth weight, gestational age, intrauterine growth restriction,
congenital malformation, stillbirth, or neonatal death [17].
Because fetal adverse events, including postoperative
abortion, stillbirth, and premature delivery, are major postop-
erative concerns, we chose these as the primary outcome.
The current study showed that the significant advantage of
laparoscopy compared with laparotomy for the primary out-
come in the analysis of unmatched groups was supported by
the analysis of propensity score matched groups. Our
results suggest that laparoscopic surgery can be performed
safely for major benign diseases during pregnancy.
Operative and maternal outcomes were significantly bet-
ter in the laparoscopic group compared with the laparotomy

Table 5
Results of operative time stratified according to operative procedure in unmatched and propensity score matched laparotomy and laparoscopy groups

Unmatched groups Propensity score matched groups

Laparotomy Laparoscopy Laparotomy Laparoscopy
(n = 4047) (n = 1971) (n = 740) (n = 740)
Operative procedure
Appendectomy 91 (1.3) 69 (2.3) 101 (3.8) 70 (3.0)
Cholecystectomy 132 (7.7) 97 (4) 146 (12) 96 (8.6)
Uterine myomectomy 124 (4.8) 121 (26) 158 (16) 121 (26)
Adnexal mass resection 98 (.8) 94 (1.5) 116 (2.1) 99 (1.7)

Values are mean (standard deviation).

6 Journal of Minimally Invasive Gynecology. Vol 00, No 00, 2018
group in the current study, even among propensity score-
matched patients. These results are consistent with previ-
ously reported findings [14 16]. Regarding the shorter
operative time in laparoscopic surgeries, some clinical fac-
tors, such as decreased bleeding, shorter time to close the
operative incision, and recent improvements in laparo-
scopic surgical techniques, could have resulted in shorter
operative times. However, the length of hospital stay in
both groups in the current study was relatively longer than
that in other countries [16]. Longer hospitalization after
surgery in pregnancy may be affected by difference in clini-
cal practice between Japan and Western nations. In Japan,
patients generally stay in the hospital for not only postoper-
ative acute care but postoperative rehabilitation. None of
the reviewed studies reported maternal mortality associated
with laparoscopic surgery during pregnancy; there was no
maternal death in our dataset.
Detailed operative results are shown in Tables 4 and 5.
The current findings indicate that patients who underwent
surgery in the third trimester had a very high risk of preterm
delivery and that laparoscopic surgery could be performed
with shorter operative times than laparotomy for all 4 oper-
ative procedures. Although myomectomy in pregnancy is
relatively rare, most patients who received myomectomy
had torsion of pedunculated myomas with severe inflamma-
tion. Clinical cases of laparoscopic myomectomy per-
formed during pregnancy for pedunculated uterine myomas
have been reported [18,19].
A strength of our study is the use of a large national data-
base. Another strength is the use of propensity score analy-
ses to decrease confounding bias. Finally, our study
concurrently analyzed 4 types of surgery for benign dis-
eases.
Several limitations of this study should be acknowl-
edged. First, the present study was a retrospective observa-
tional study based on an administrative database, and it
lacked some clinical information, such as parity, uterine
contractions, Apgar score of neonates, and laboratory blood
tests. Second, we did not know whether laparoscopic proce-
dures were performed with pneumoperitoneum or with the
gasless method. Third, postoperative outcomes that
occurred after hospital discharge could not be detected
from our dataset, although a previous study reported cases
of postoperative fetal loss within a couple of months after
surgery [20]. Finally, the number of myomectomy and cho-
lecystectomy procedures was relatively small in our data-
set; these surgeries should be further evaluated in future
studies.
In conclusion, our study showed significantly less fetal
adverse events and better operative and maternal outcomes
after laparoscopic surgery compared with laparotomy dur-
ing pregnancy. Laparoscopic surgery can be performed
safely for major benign diseases including appendicitis,
cholecystitis, adnexal masses, and uterine myoma during
pregnancy.
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