DOI: 10.1093/humrep/deh413
Human Reproduction Vol.19, No.10 pp. 2367–2371, 2004
Advance Access publication July 8, 2004
A prospective randomized study of laparoscopy
and minilaparotomy in the management of benign
adnexal masses
Francesco Fanfani1, Anna Fagotti1, Alfredo Ercoli2, Giuseppe Bifulco1, Romina Longo2,
Salvatore Mancuso2 and Giovanni Scambia1,3
1
Department of Oncology, Catholic University of the Sacred Heart, Campobasso and 2Department of Obstetrics and Gynaecology,
Catholic University of the Sacred Heart, Rome, Italy
3
To whom correspondence should be addressed at: Department of Gynaecology, Catholic University, L.go A. Gemelli, 8, 00168,
Rome, Italy. E-mail: [email protected]
BACKGROUND: Recent prospective and randomized studies have demonstrated that laparoscopy is better than
laparotomy in the treatment of benign adnexal masses. The aim of this study is to analyse the perioperative
outcomes of laparoscopy and minilaparotomy in these patients, in a prospective and randomized manner.
METHODS: Between January 2003 and August 2003, 100 consecutive women with a diagnosis of presumed benign
adnexal mass and requiring surgical treatment were randomly assigned to minilaparotomy and laparoscopy. Randomization was centralized and computer-based. RESULTS: All operative procedures were performed without
conversion to laparotomy. In the group of patients submitted to minilaparotomy, a shorter operating time than
patients submitted to operative laparoscopy (mean 6 SD: 71.9 6 31.8 versus 87.0 6 44.8 min; P < 0.05) was found.
On the other hand, there were significant differences in terms of postoperative ileus (1.1 6 0.4 days in laparoscopy
and 1.4 6 0.6 in minilaparotomy P < 0.023), without affecting the day of discharge. No intraoperative or early
complications were registered in either group. CONCLUSIONS: Taking into account that laparoscopy has to be
considered the first choice for benign adnexal surgery, our data suggest that minilaparotomy could offer the gynaecology surgeon a valid alternative in the minimally invasive surgery field, especially in specific settings.
Key words: adnexal masses/laparoscopy/minilaparotomy
Introduction
Thanks to its well-known advantages such as the reduction in
perioperative morbidity, hospital stay and recovery time
(Canis et al., 1997; Hidlebaugh et al., 1997), laparoscopy has
been used with increasing frequency in the management of
benign adnexal masses over the last 10 years (Canis et al.,
2002). The few prospective studies comparing this technique
with the classical laparotomy have shown that it should
replace open surgery in the treatment of benign adnexal
masses (Yuen et al., 1997). Moreover, in spite of the reported
higher costs of laparoscopy due to the surgical instruments,
the longer operative time and learning curve, no significant
differences in total hospital charges have been demonstrated
between laparoscopy and laparotomy (Carley et al., 2003).
However, some specific advantages of laparotomy such as
shorter operative time (Carley et al., 2003), a shorter learning
curve, and the absence of pneumoperitoneum, which could
be contraindicated in patients with severe obesity or a critical
physical status (Marana et al., 2003), should be considered.
In this context, minilaparotomy could offer the patients a less
invasive surgical access than standard laparotomy (BenedettiPanici et al., 1996; Fagotti et al., 2002). We previously
demonstrated that it fulfils the criteria of minimally invasive
surgery (Fagotti et al., 2002; Fanfani et al., 2004) with a
very small and aesthetic abdominal incision. Moreover, in a
pilot study minilaparotomy was shown to create a neuroendocrine response similar to laparoscopy but smaller than a classic laparotomy (Marana et al., 2003).
A retrospective evaluation of minilaparotomy in the management of benign gynaecological disease was carried out at
our Department in the year before this study accrual, showing
comparable results in terms of overall patient outcomes with
respect to laparoscopy (Fanfani et al., 2004). Nevertheless, to
date no studies have compared laparoscopy and minilaparotomy for surgical treatment in a randomized and prospective
manner.
The aim of this study was to analyse the operative data
and the perioperative complications of these two minimally
Human Reproduction vol. 19 no. 10 q European Society of Human Reproduction and Embryology 2004; all rights reserved
2367
F.Fanfani et al.
invasive approaches in a consecutive series of patients with a
presumed benign adnexal mass randomly assigned to each
surgical route.
Materials and methods
The study was carried out at the Department of Gynaecologic
Oncology of the University of the Sacred Heart, Rome. Since
January 2003 and August 2003, all women with a diagnosis of presumed benign adnexal mass and requiring surgical treatment were
evaluated for the study. Absolute exclusion criteria were considered
a body mass index (BMI) . 32 kg/m2, the cysts with a maximum
diameter .12 cm measured by ultrasonography, or whether a hysterectomy was required at the same time. Postmenopausal patients
with CA 125 levels .35 UI/ml were also excluded from the study.
A written informed consent was obtained from all patients entering the study, and the randomization was performed on the day of
surgery. Randomization was centralized and computer-based. Those
patients randomized to laparoscopic surgery were counselled that
laparotomy would be carried out if difficulties were encountered
with the laparoscopic approach and if malignancy was suspected.
Patients assigned to minilaparotomy were informed of the possibility of enlarging the skin incision in the same circumstances. All
patients were counselled that in the case of an unexpected intraoperative diagnosis of malignancy, a classic vertical incision could
be performed. The study was stopped when 100 consecutive patients
were enrolled: 50 patients were allocated to each group (Figure 1).
The power calculation of the study was .80%. Age, BMI, menopausal status, concomitant systemic diseases, previous surgery,
operative time (minutes), estimated blood loss (millilitres), complications, and postoperative outcome were recorded prospectively.
Standard preoperative assessment was carried out together with
serum markers, and an ultrasonographic scan with colour Doppler
evaluation to evaluate the size and the characteristics of the lesions.
Figure 1. Flow diagram.
2368
Surgical procedures were always performed by one senior and
one fellow, both for laparoscopy and minilaparotomy.
Bowel preparation and antithrombotic prophylaxis were always
performed, and a short-term intraoperative prophylactic antibiotic
therapy by a second generation cephalosporin was administered to
all patients. When necessary, a frozen section analysis was performed, and in the case of invasive ovarian cancer disease we
would switch to a standard laparotomy. The decision for oophorectomy or ovarian cystectomy depended on the age of the patient
and on the surgical findings.
As previously reported (Fanfani et al., 2004), under general endotracheal anaesthesia, the patient was positioned in a steep Trendelenburg position and a Foley catheter was placed in the bladder. A
4 – 9 cm transverse (vertical in case of a previous longitudinal scar)
skin incision was made 1 – 2 cm below the pubic hair line 2 – 4 cm
above the pubic symphysis. In order to reduce surgical stress and
prolong post-operative analgesia, the skin and the subcutaneous fat
were locally infiltrated with Naropine (7.5 mg%) and Xilocaine
(2 mg%) (Morisaki et al., 1996) before the incision, and at the end
of surgery in the case of an operative time .2 h. To avoid the accidental lengthening of the incision, it was sutured at both ends. The
subcutaneous fat was dissected and the abdominal fascia opened
transversely 2 – 3 cm above the skin incision to a width of 10 –
12 cm. To prevent bowel and bladder injuries, the peritoneum
was opened manually and dissected caudo-cranially. Only when
required, the bowel was packed upward with warm, wet pads. The
self-retaining retractor was replaced with two or three Deaver retractors (width 2.5 – 3.5 cm, length 5 – 24 cm). The surgical technique
was basically the same as in laparotomy, but the surgeon had to perfect his/her skills in working with the instruments in a vertical position, because their wide inclination was not possible. Moreover,
given the small dimension of the operative window, the affected
organs were pulled toward or through the abdominal wall. Meticulous and prompt haemostasis by electro-coagulating forceps allowed
the surgeon to keep the operative field bloodless and proceed safely
and quickly.
When possible, the discharge of the cyst through the incision can
facilitate and accelerate the procedure. Salpingo-ophorectomy and
cystectomy were performed according to the classical technique.
As previously reported (Fagotti et al., 2002), when necessary
such as in the case of an unexpected borderline malignant or ovarian
tumour diagnosed by frozen section analysis, an upper abdomen
exploration through a videolaparoscope is performed.
A scar measurement was made at the end of surgery, in order to
check any possible lengthening due to the traction on the skin.
All laparoscopic procedures were performed through four ports, a
10 mm transumbilical port for the laparoscope and three 5 mm ports
on the right and the left pelvis, and sovrapubic, respectively. Dissection was carried out with either curved dissector or scissors and haemostasis achieved by bipolar coagulation. In the case of mono- or
bilateral salpingo-ophorectomy, the ureter was first identified at its
entrance into the pelvis and then isolated from the infundibulo
pelvis. To avoid ureteral damage due to electrosurgery, the ovarian
vessels were coagulated and sectioned after opening a window into
the peritoneum close to the posterior wide ligament. All procedures
were carried out with a technique simulating that performed by
laparotomy without intentionally puncturing the masses. The ovarian
defect was left open and the edge inverted by coagulating the inner
surface of the defect. Specimens were removed by a bag-retrieval
technique through the transubumbilical port using a 5 mm laparoscope in the right ancillary port.
Patient-controlled analgesia with morphine chloridate and ketoralac was the primary modality of postoperative pain control.
Laparoscopy and minilaparotomy for benign adnexal masses
Operative complications were defined as bowel, bladder, ureteral
or vascular injuries and an estimated blood loss . 200 ml. Anaemia
was considered in the case of haemoglobin levels , 8 g/dl and fever
in the case of body temperature $ 388C in two consecutive measurements $ 6 h apart, excluding the first day after surgery. Patients
were allowed to go home when they were fully mobile, apyrexial,
passing urine satisfactorily, and not requiring narcotic analgesia.
Postoperative complications were defined as any adverse event
occurring within 30 days from surgery and considered severe if they
resulted in unplanned admission, blood transfusion, or secondary
surgical procedure.
Comparison of the patients’ surgical outcome and the length of
recovery between the two groups was performed using the Mann –
Whitney U-test and the frequency data were analysed using Fisher’s
exact test or x2-test as appropriate. P , 0.05 was considered statistically significant.
Results
One hundred consecutive patients were enrolled in the study
and were randomly assigned to laparoscopy and minilaparotomy. The two groups were similar in age, BMI, menopausal
status, and preoperative diagnosis (Table I). All laparoscopies
and minilaparotomies were successfully completed without
conversion to classical laparotomy.
The mean ^ SD cyst diameter was 6.2 ^ 2.5 and
5.9 ^ 2.3 cm in the laparoscopy and minilaparotomy groups
respectively (not significant). Eight patients (16%) in the
laparoscopy group and five (10%) in the minilaparotomy
group had bilateral disease. Cystectomy was performed in 42
cases (84%) in the laparoscopy group and 40 (80%) in the
minilaparotomy group. In the remaining cases a monolateral
[two (4%) in the laparoscopy group and six (12%) in the
minilaparotomy group] or bilateral [six (12%) in the laparoscopy group and four (8%) in the minilaparotomy group]
salpingo-ophorectomy was performed.
Based on intraoperative findings, we performed frozen section analysis in 11 (11%) cases. In eight of these cases a
benign ovarian lesion (six serous and two mucinous) was
intraoperatively identified. In the remaining three cases (3%),
one in the minilaparotomy group and two in the laparoscopy
group, unexpected mucinous ovarian borderline tumours
Table I. Characteristics of patients in the study population
Age (years) (mean ^ SD)
Body mass index (mean ^ SD)
Menopausal
Previous laparotomy
Previous laparoscopy
Presentation
Asymptomatic
Pelvic mass
Menstrual disturbance
Dysmenorrhoea
Pelvic pain
Infertility
Laparoscopy
(n ¼ 50)
Minilaparotomy
(n ¼ 50)
36.3 ^ 12.1
21.8 ^ 6.1
5 (10)
7 (14)
3 (6)
37.5 ^ 13.4
23.4 ^ 3.7
7 (14)
10 (20)
2 (4)
15 (30)
10 (20)
8 (16)
12 (24)
7 (14)
10 (20)
12
16
5
14
10
5
Values in parentheses are percentages.
No significant differences between groups.
(24)
(32)
(10)
(28)
(20)
(10)
Table II. Operative data
Operating time
(min) (mean ^ SD)
Estimated blood
loss (ml) (mean)
Complications
Conversion to
laparotomy
Laparoscopy
(n ¼ 50)
Minilaparotomy
(n ¼ 50)
P
87.0 ^ 44.8
71.9 ^ 31.2
0.05
,100
,100
NS
0
0
0
0
NS
NS
NS ¼ not significant.
were found. These three cases were submitted to an intensive
surgical staging without conversion to classic laparotomy.
At definitive histopathological diagnosis, all except three
cases were benign. In particular, endometriotic cysts were
found in 33 patients (33%), benign ovarian and parasalpingoserous cysts in 32 cases (32%), dermoid in 18 cases (18%),
and benign mucinous cysts in 16 cases (16%). Excluding
endometriotic cysts, the overall frequency of inadvertent rupture of the cysts during operation was 6% in the laparoscopy
group and 2% in the minilaparotomy group.
Operative data are shown in Table II. The mean ^ SD
operating time was 87.0 ^ 44.8 and 71.9 ^ 31.8 min in the
laparoscopy and minilaparotomy groups respectively
(P , 0.05). The estimated blood loss was not significant in
the two groups. No intraoperative complications were registered in either group.
As shown in Table III, no cases of postoperative fever and
anaemia were found in the laparoscopy group, whereas in the
minilaparotomy group there were two cases (4%) and one
case (1%) with fever and with anaemia not requiring transfusion respectively. All patients were started on clear liquid
diets on the evening of the day of surgery in the laparoscopy
group and on postoperative day 1 in the minilaparotomy
group. The mean ^ SD duration of ileus was 1.1 ^ 0.4 days
in laparoscopy and 1.4 ^ 0.6 in minilaparotomy (P , 0.023).
The mean ^ SD days of discharge was 2.0 ^ 0.8 and
2.2 ^ 0.6 days in laparoscopy and minilaparotomy respectively (not significant). In the early postoperative course there
were no statistically significant differences between minilaparotomy (mean ^ SD: 1.2 ^ 0.6 vials) and laparoscopy
(mean ^ SD: 1.3 ^ 0.5 vials) in the amount of analgesics
required (not significant).
Table III. Postoperative data
Ileus (days) (mean ^ SD)
Discharge (days) (mean ^ SD)
Fever
Anaemia
Early complications
Laparoscopy
(n ¼ 50)
Minilaparotomy
(n ¼ 50)
P
1.1 ^ 0.4
2.0 ^ 0.8
0
0
0
1.4 ^ 0.6
2.2 ^ 0.6
2 (4)
1 (2)
0
0.023
NS
NS
NS
NS
Values in parentheses are percentages.
NS ¼ not significant.
2369
F.Fanfani et al.
No patients were submitted to a second surgery for early
postoperative complications and no wound infections or
dehiscence was registered in the 30 days after surgery.
Discussion
To date, minimally invasive surgery has to be considered the
gold standard in the surgical treatment of presumed benign
adnexal masses (Canis et al., 1997). This is the first prospective study in the present literature to compare two minimally
invasive approaches, such as laparoscopy and minilaparotomy, randomly assigned to patients undergoing surgery for
presumed benign adnexal masses.
In this study, all operative procedures were performed
without conversion to standard laparotomy, even in three
cases of unexpected borderline ovarian tumours requiring an
intensive surgical staging.
As far as the perioperative outcomes are concerned, it is
well accepted that laparoscopy is a better operative approach
than classic laparotomy in the management of benign adnexal
masses (Yuen et al., 1997; Carley et al., 2003). In this
context, attempts to explore less invasive transabdominal
incisions, such as minilaparotomy, could represent an alternative to laparoscopy in some specific conditions, such as cardiorespiratory contraindications or the presence of an unskilled
laparoscopic surgeon. We have previously demonstrated that
considering the low extent of tissue trauma and the absence
of retractors, minilaparotomy can elicit a neuroendocrinal
response less relevant than laparotomy and similar to laparoscopy (Marana et al., 2003). As far as early postoperative
outcome is concerned, in our study we found no significant
differences in terms of the amount of analgesics required to
control postoperative pain. The induction of pneumoperitoneum seems to cause serious intraoperative complications in
those patients with severe obesity or with a critical physical
status, suggesting that high risk patients should be treated by
Figure 2. Decision making algorithm.
2370
minilaparotomy or vaginal surgery (Hachenberg et al., 1998).
Moreover, we have previously demonstrated that minilaparotomy fulfils the criteria of minimally invasive surgery and
can be safely used in the management of benign and neoplastic disease (Fagotti et al., 2002; Fanfani et al., 2004). In the
present study, in the group of patients submitted to minilaparotomy a shorter operating time than patients submitted to
operative laparoscopy (71.9 ^ 31.8 versus 87.0 ^ 44.8 min;
P , 0.05) was observed. On the other hand, there were significant differences in terms of postoperative ileus (1.1 ^ 0.4
days in laparoscopy and 1.4 ^ 0.6 in minilaparotomy;
P , 0.023), without affecting the day of discharge. In
addition, no intraoperative or early complications were registered in either group. These data suggest that both surgical
approaches fulfil the criteria of minimally invasive surgery.
Operative laparoscopy generally requires a longer operating time, especially due to the time of specimen removal. On
the other hand, during laparotomy a part of the operating
time is spent in the opening and closing of the abdominal
wall. As shown in our study, minilaparotomy, with a narrower surgical field, can offer a time advantage in these
surgical steps. On the contrary, the presence of adnexal adhesions, due to previous abdominal surgery or endometriosis,
can represent a technical limitation for the minilaparotomy
that can be more easily overcome by the wider vision and the
abdominal distension offered by laparoscopy (Pelosi and
Pelosi, 1996). Furthermore, laparoscopy allows an optimal
inspection of the peritoneal surface that, when required,
should be performed during the surgical management of suspicious adnexal masses.
The rupture of the cysts during surgery has been demonstrated to have an unfavourable clinical impact in patients
with unexpected ovarian cancer (Vergote et al., 2001), and
laparoscopy is generally believed to increase the risk of cyst
rupture and spillage of the cyst content with respect to open
surgery (Flynn and Niloff, 1999; Pejovic and Nezhat, 2001).
Laparoscopy and minilaparotomy for benign adnexal masses
Our data confirmed this opinion, assessing that, excluding
endometriotic cysts, the overall frequency of inadvertent rupture of the cysts during operation was 6% in the laparoscopy
group and 2% in the minilaparotomy group.
An adequate preoperative evaluation should be carried out
to exclude possible malignancy including the history, examination, ultrasonography, and measurement of ovarian tumour
markers. Experienced ultrasonographers using some clinical
information and their subjective assessment of ultrasonographic images can differentiate malignant from benign
masses in most cases. The accuracy and the level of interobserver agreement are both correlated with experience,
varying from 82% in less experienced to 92% in the most
experienced investigators (Timmerman et al., 1999). About
10% of adnexal masses were extremely difficult to classify,
and were defined as unknown (Timmerman et al., 1999). We
believe that an explorative laparoscopy could be considered
during the surgical approach in this specific group.
In conclusion, taking into account that laparoscopy has to
be considered the first choice for benign adnexal surgery, our
data suggest that minilaparotomy could offer gynaecology
surgeons a valid alternative in the minimally invasive surgery
field, especially in specific settings. In addition, we believe
that surgeon and patient preference and characteristics, rather
than costs, should be the primary consideration in selecting
surgical methods in all patients with an adnexal mass suitable
for surgical treatment (Figure 2).
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Submitted on October 28, 2003; resubmitted on April 29, 2004; accepted on
June 22, 2004
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