TUBAL ECTOPIC PREGNANCY: LAPAROSCOPY
VERSUS LAPAROTOMY.
M NABIL EL TABBAKH (M.D), M SHERIEF EL SAYES (M.D)
Department
of Obstetrics and Gynecology, Faculty of Medicine, Al
Abstract
Objectives: To compare the efficiency of laparoscopic treatment versus conventional abdominal surgery in the treatment of ectopic pregnancy (EP) and to review the clinical presentation, evaluate methods of diagnosis, and identifying the risk factors.
Method: In this prospective
study there were 207 with a confirmed EP at
Results: Laparoscopic surgery gives an
overall success rate of 98.9%. Linear salpingostomy was the main procedure
performed in both groups. Estimated blood loss was significantly lower in the
laparoscopy group (P<0.0001).The duration of operation in laparoscopy group
was 66.46±19.97 min and 72.52±20.01 min in the laparotomy group. The duration
of hospitalization was significantly shorter in the laparoscopy group
(P<0.0001).Only 13 (7%) patients in the laparoscopy group required blood
transfusion, whereas 6(23%) in the laparotomy group needed transfusion
(P<0.01).There were no intraoperative complications in either group. Eighty
patients (47.3%)
in the laparoscopy did not need analgesia after surgery compared to laparotomy
group where all the patients need analgesia. The average time taken for the
B-hCG to return to normal (<20 IU/l) was 12 days after conservative surgery
in both groups. The cumulative frequency of hCG elimination down to the non
pregnant level (<20 IU/l) was similar in both groups.
conclusion: laparoscopic treatment
(salpingostomy or salpingectomy) of EPs offers major benefits superior to
laparotomy in terms of less blood loss, less need for blood transfusion, less
need for postoperative analgesia and a shorter duration of hospital stay.
Keywords:
laparoscopic surgery, ectopic pregnancy, laparoscopy, salpingostomy,
salpingectomy.
Introduction and aim of work
The incidence of ectopic pregnancy (EP) has increased all
over the world from 0.5% thirty years
ago, to a present day 1-2%(1).This
complication of early pregnancy, results in not only fetal loss, but also the
potential for considerable maternal morbidity and the risk of maternal death
(2)(3)(4). Until the risk factors that lead to EP are more fully understood,
early detection and appropriate management will be the most effective means of
reducing the morbidity and mortality associated with this condition (5)(6).
Although the incidence of EP increased, with the improvement of diagnostic
approaches, patients were detected at an earlier stage and possible to be
treated more conservatively.(7).Surgery remains the mainstay of
treatment.(8).Surgical treatments may be radical (salpingectomy) or
conservative (usually salpingostomy), and they may be performed by
laparoscopy or laparotomy (9).Improved anesthesia and cardiovascular
monitoring, together with advanced laparoscopic surgical skills and experience,
justifies operative laparoscopy for surgical treatment of EP even in women with
hemodynamic instability.(10)(11).Improvements in management have led to a fall
in the mortality rate from 2.9 per 1000 EPs in the early 1970s to 0.4 per 1000
in 1994-1996.(6).
This prospective clinical trial was conducted to compare the efficiency of laparoscopic treatment versus conventional abdominal surgery for tubal ectopic pregnancy and to review the clinical presentation, evaluate methods of diagnosis, and identifying the risk factors.
Patients and Methods
We
conducted a prospective study in two centers: Department of Obstetrics and
Gynecology, Hadi Hospital and Department of Obstetrics and Gynecology,
El-Rashed Hospital, a private hospitals in Kuwait state, during the period from
March 1999 to October 2001.During this period, there were 207 with a confirmed
ectopic pregnancy (62 cases at El-Rashed hospital &145 cases at Hadi
hospital).These patients were admitted through
emergency or outpatient department. Patients were managed by laparoscopy
(No 184) and by laparotomy (No 23).The
diagnosis of ectopic pregnancy was based on history, clinical symptoms,
physical examination, a positive serum B-human chorionic gonadotrophin (B
hCG),transvaginal ultrasonography (ultrasound
findings of empty uterus with or without adnexal mass),and confirmed at laparoscopy .All patients had diagnostic
laparoscopy as the primary procedure to confirm the diagnosis and to evaluate
the contra lateral tube before deciding which surgical approach would be
performed. The selection of operative approach was not based on any defined
criteria, but depended on the availability of laparoscopic facilities and the
surgical team. Once the EP had been diagnosed laparoscopically, the choice of
whether the patient would undergo a laparotomy or be managed laparoscopically
depended on the surgeon on call. Those not trained in operative laparoscopy
proceeded to perform a laparotomy.All laparoscopic procedures were performed by
the first author at Hadi hospital and the second author at El-Rashed hospital. Patients were counseled pre operatively about the
operative procedures and the risks and complications of operative laparoscopy,
conservative procedures for EPs and the need for follow-up. All operations were
conducted under general anesthesia with endotracheal intubation.After thorough evaluation, type of management was decided.
Surgical procedure was performed and the surgical specimens were sent for
histopathological examination.Ectopic pregnancy was histologically confirmed in
all these specimens.
Operative
laparoscopy
Laparoscopic
surgery was performed using three ports. Following the establishment of
pneumoperitoneum, a 10 mm 00 laparoscope was introduced through an
11 mm cannula in intra-umbilical incision. After a confirmation of the
diagnosis and laparoscopic treatment was deemed possible, a 5 mm puncture was
made in the left and right lower quadrant using direct visualization and
transillumination to avoid the epigastric vessels with continuous high flow
carbon dioxide insufflators. The procedure was visualized on a video monitor using
a camera (Endovision Telecam,Karl Storz,Germany) attached to the eyepiece of
the telescope. Linear salpingostomy was performed by making a linear incision
in the anti mesenteric border of the affected tube over the tubal swelling with
point needle monopolar diathermy. The pregnancy was removed with a forceps, the
tube was irrigated with lactated Ringer's solution and haemostasis was achieved
with bipolar diathermy. The tubal incision was then left to heal by secondary
intention. Laparoscopic total salpingectomy was performed by progressive coagulation and cutting of the mesosalpinx,
starting with the fimbriated end and progressing to the proximal isthmic
portion of the tube. There, it was separated from the uterus after bipolar
coagulation or loop-type ligation and cutting with scissors. Milking of tube
(tubal expression) was done for patients with fimbrial EP.The pregnancy
was removed from the abdominal cavity via a 10 mm port. Just prior to
withdrawal of the laparoscope the pneumoperitoneum was released and haemostasis
was checked to ensure that any 'tamponade effect' caused by the raised intra
abdominal pressure was detected. The pelvis was irrigated with copious amounts
of lactated Ringer's solution until all blood clots were evacuated. Adhesions
in the contra lateral fallopian tube were freed, if present. Half liter of
lactated Ringer's solution was left in the pelvis at the conclusion of the
operation to help prevent adhesion formation (12).In the presence of
haemoperitoneum, the amount of blood present was assessed by the difference
between the amounts of fluid irrigated and evacuated. Post-operative management
followed the normal practice in both departments. Analgesia was prescribed to the
patients on demand, namely pethidine, 1.5 mg/kg I.M every four hours or
diclofenac sodium 100 mg, (Rofenac tablets&ules,
Laparotomy
Laparotomy
was performed through a Pfannenstiel incision and
standard surgical techniques (the same laparoscopic
techniques were applied).
After surgery, To detect persistent viable
trophoblastic tissue all patients were followed up by
serial serum B-hCG levels on day 4 and day 7 and then weekly
until non-pregnant levels (< 20 IU/l) were reached, with weekly clinical
examination and transvaginal ultrasound scans if needed.
Statistical evaluation
The clinical and surgical data were
recorded in an investigative report form. These data were transferred to IBM-card,
using IBM-PC with statistical program SPSS under window VER.6.1 to obtain:
1-Descriptive Statistics: A-Mean, B-Standard deviation (±S.D), C-Range
(minimum-maximum), D-Number and percent .2-Analysis Statistics: a Student’s ״ t test,
Chi square test and Fisher’s exact test.P-value of less than 0.05was considered
significant.
Results
During the study period, 207 patients presented with an EP
(all of these were included in the study) and 19060 live births (7260 at
El-Rashed hospital &11800 at Hadi hospital) giving a total incidence of 1
ectopic pregnancy for every 92 (1.1%) live births. Patients were divided into 2
groups: Group I (n=184) had their EPs removed laparoscopically; Group II (n=23)
had a laparotomy. A comparison of the demographic and clinical data of the two
groups is shown in Table 1.There were no difference in the mean age, parity,
preoperative serum B-hCG, past gynecological history of pelvic infection,
frequency of previous EP, prior laparotomy,gestational age at the time of
surgery, use of intrauterine device and preoperative hemoglobin levels. Most
(58%) of our patients were within the 21-32 age group.Parous women constituted
64% and nulliparous patients constituted 23% of the study group. previous
history of abortion was found in 26% of the patients. According to the
ethnicity of women included in the present study, they were:1:Kuwaitis (175
women),2:Non-Kuwaitis,other Arabs (14 women),3:Non-Kuwaiti,Non-Arab (18
women).The diagnosis of EP was based on history, clinical symptoms, physical examination,
a positive serum pregnancy test,transvaginal sonography and laparoscopy.
History of infertility was found in 14%,Use of an intrauterine contraceptive
device was found in 12% and Previous ectopic pregnancy was found in 3.4%.The
presenting symptoms were abdominal pain (96%), short period of amenorrhea (89%)
and Vaginal bleeding (79%).The presenting signs were abdominal tenderness
(89%),and adnexal tenderness (64%). The diagnoses of EP in 86% were confirmed
by ultrasound. The study showed that 40% of EP was ruptured at the time of
presentation.
The operative outcome is summarized in table 2.All the EPs
were tubal.In 164 patients (79.2%) it was in the right fallopian tube and in 43
patients (20.8%) it was in the left fallopian tube. Among those attempted
laparoscopically, only two had to undergo a laparotomy because of failure of
the laparoscopic approach. This gives an overall success rate of 98.9% for
attempted laparoscopic removal of the pregnancy. Failure of the laparoscopic
approach because in one case it was not possible to achieve pneumoperitoneum
because of extreme obesity. In the second case because of technical problems in
the instruments. There was no difference in the mean diameter of the intact
tubal pregnancy. The incidence of haemoperitoneum (>100 ml of blood in the
pelvis) was lower in the laparotomy group. The greatest estimated
hemoperitoneum was 2,340 mL. Estimated blood loss was significantly lower in
the laparoscopy group (P<0.0001).Linear salpingostomy was the main procedure
performed in the laparoscopy and laparotomy groups (96.2% &73.9%
respectively) (table 2).The duration of operation in laparoscopy group was 66.46±19.97
min and 72.52±20.01 min in the laparotomy group and the difference between the
durations of operations was not considered to be significant. The duration of hospitalization
was significantly shorter in the laparoscopy group (P<0.0001).Only 13 (7%)
patients in the laparoscopy group required blood transfusion, whereas 6(23%) in
the laparotomy group needed transfusion (P<0.01).There were no
intraoperative complications in either group. Postoperatively four patients in
the laparoscopy group developed bruising over the umbilical wound, which
resolved spontaneously with ordinary care, while one patient in the same group
developed extensive bruising over the umbilical wound and extended to the lower
abdomen, which resolved after three weeks with ordinary care. Eighty patients
(47.3%) in the laparoscopy did not need analgesia after surgery compared to
laparotomy group where all the patients need analgesia.
On analysis of the pathological changes of ectopic
trophoblastic tissue it was found that 113 (54.59%) specimens were
histologically reported as unremarkable deciduas and chorionic-villi,39
specimens (18.84%) as hemorrhage with degenerated product of conception,28
(13.53%) as trophoblastic tissue with hemorrhage, and 27 (13%) as trophoblastic
tissue with fibrosis. The average time taken for the B-hCG to return to normal
(<20 IU/l) was 12 days after conservative surgery in both groups. The
cumulative frequency of hCG elimination down to the non pregnant level (<20
IU/l) was similar in both groups (Fig 1).
Discussion
The technical advancement in the field of minimal access
surgery has greatly enhanced the possibility of both diagnosing and treating EP
effectively. (13). Since the first excision of a tubal pregnancy through a
laparoscope by Shapiro & Adler (14), it has been used with increasing frequency.
and the laparoscopic approach for management of EP has replaced laparotomy.
(8)(15).The frequency of EP in our series was 1.1%.In
The study showed that 40% of EPs were ruptured at the time of presentation. In the prospective study of Soyannwo the ruptured EPs were 81.1%.(24).This difference may be related to the fact that most Kuwaiti women are regularly attendants for antenatal care starting in very early pregnancy and they are keen to do early B hCG and transvaginal sonography. In our laparoscopic group, the greatest estimated hemoperitoneum was 2,340 mL and the procedure was carried through successfully. Laparoscopy is not only suitable for early EPs but it is also safe and feasible in instances where there is tubal rupture and hemoperitoneum, provided the patient is not severely compromised haemodynamically (25) (26) There was a significant reduction of total blood loss (P<0.0001), number of patients who needed blood transfusion (P<0.01), total days needed for hospital admission (P<0.0001) and the need for postoperative analgesia in the laparoscopic group versus laparotomy group (P<0.0001). These findings were in agreement with previous studies. (9)(27)(28).In the present study laparoscopic techniques (salpingostomy or salpingectomy) do not increase the operating time. In fact, it actually saves time, as during a laparotomy, opening and closing the abdomen just to gain access to the affected tube consumes precious operating time. Previous comparative studies support this (9) (29).In the present study we have demonstrated that EPs can be managed successfully via minimal access surgery and Laparoscopic management offer several advantages over conventional treatment via laparotomy (Table 2). It not only results in reduced hospital stay with associated financial savings but also reduced patient morbidity, enabling women to return to their normal activities much sooner.(9)(19)(26).Also it has been shown that conservative surgery is more likely to be performed if the laparoscopic approach is used.(26).Our study confirms these results. The laparoscopic procedure performed depends on the site of the EP. An ampullary pregnancy is best be dealt with by performing a linear salpingostomy as described above. Linear salpingostomies are allowed to heal by secondary intention as it has been shown that there is no significant difference in adhesion formation nor in tubal patency rates whether the tube is sutured or not and the cumulative intra uterine pregnancy rates are similar (30). Cornual pregnancies generally require a laparotomy and surgical excision (31); although cases have been successfully managed via the laparoscope (32).Our study confirm this. If the affected tube is conserved, the patient should be followed by serial hCG estimations until these return to normal. This can take several weeks and the patient should be made aware of that possibility pre-operatively. Follow up is necessary because of the possibility of persistent trophoblastic tissue in the fallopian tube. Most series report an incidence of 5-10 %.( 26) (33).We had no cases amongst the 201 patients who had conservative surgery on the tubes (in both groups), with persistent trophoblastic tissues after surgery. These findings may be due to the preoperative levels of serum b-hCG < 3000 IU/l.Brumsted et al. (29) reported a frequency of second interventions of 8% in their laparoscopy group and zero in their laparotomy group. Complication in terms of second surgical intervention are related to the preoperative levels of serum hCG (34).In our study the postoperative elimination of hCG was similar in both the laparoscopy and laparotomy-treated patients, whether treated by conservative salpingostomy or radical salpingectomy,implying that the radicality in removing the trophoblastic tissue is as efficient by laparoscopy as by laparotomy.In the present study we have demonstrated that, the majority of tubal ectopic pregnancies can be managed laparoscopically. During the study period, of the 186 patients in whom laparoscopic management was attempted, 98.9% were successful. Operative laparoscopy is currently the best treatment for EP (8).The benefits to patients are self-evident and our findings are supported in the literature.
We concluded that laparoscopic treatment
(salpingostomy or salpingectomy) of EPs offers major benefits superior to
laparotomy in terms of less blood loss, less need for blood transfusion, less
need for postoperative analgesia and a shorter duration of hospital stay.
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|
Table 1:Demographic and
clinical data of the study groups. |
|
||||
|
|
|
Laparoscopy |
Laparotomy |
P value |
|
|
|
|
(n=184) |
(n=23) |
|
|
|
Age (Mean±SD),years |
27.6± 5.7 |
28.5±4.6 |
N.S |
|
|
|
Parity (Mean) |
0-7 (2.04) |
0-6 (2.02) |
N.S |
|
|
|
Preoperative B hCG
levels* |
2327.82±542.182 |
2303.78±473.235 |
N.S |
|
|
|
Previous PIDs**(n)(%) |
20 (10.9%) |
3 (13.0%) |
N.S |
|
|
|
Previous ectopic (n)(%) |
6 (3.8%) |
1 (4.3%) |
N.S |
|
|
|
Previous laparotomy (n)(%) |
28 (15.2%) |
4 (17.4) |
N.S |
|
|
|
Gestation at diagnosis*** |
8±1.7 |
8.5±1.8 |
N.S |
|
|
|
IUCD in
situ (n)(%) |
22 (11.9%) |
3 (13.0%) |
N.S |
|
|
|
Preoperative haemoglobin
levelsª |
10.07±2.8 |
10.4±3.4 |
N.S |
|
|
|
*IU/ml (Mean±SE) |
**PIDs=Pelvic
inflammatory diseases |
|
|||
|
***weeks (Mean±SE) . |
ªmg/dl (Mean±SD) |
|
|
|
|
|
|
|
|
|
|
|
|
Table 2: Operative outcome in the laparoscopy and
laparotomy groups. |
||||||
|
|
|
Laparoscopy |
Laparotomy |
Pvalue |
||
|
Location of the EP* |
|
|
|
|
|
|
|
Ampullary |
|
177 (96.2%) |
|
22 (95.7) |
|
N.S |
|
cornual |
|
2 (1.1%) |
|
1 (4.3%) |
|
N.S |
|
Fimbrial |
|
5 (2.7%) |
|
0 (0%) |
|
|
|
Side of the EP* |
|
|
|
|
|
|
|
Right |
|
146 (79.3%) |
|
18 (78.3%) |
N.S |
|
|
left |
|
38 (20.7%) |
|
5 (21.7) |
|
N.S |
|
Size of tubal
pregnancy** |
3.7±1.3 |
|
3.6±1.5 |
|
N.S |
|
|
Haemoperitoneum (n)(%) |
108 (58.7%) |
|
13 (56.5%) |
N.S |
||
|
Blood loss (ml) |
79.62 ± 96.7 |
|
270.7±138.4 |
<0.0001 |
||
|
Procedure performed (n)(%) |
|
|
|
|
|
|
|
Linear salpingostomy |
179 (97.3%) |
|
19 (82.6%) |
|
||
|
Salpingectomy |
2 (1.1%)# |
|
4 (17.4%)## |
|
||
|
Milking |
|
3 ( 1.6%) |
|
0 (0%) |
|
|
|
Duration of surgery (min)*** |
<||||||