M. Sherief El Sayes, MD

 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. 

 In this prospective study there were 207  with a confirmed EP at Hadi Hospital and El-Rashed Hospital, private  hospitals in Kuwait. Of these 184 were treated laparoscopically and 23  were treated by laparotomy. The diagnosis of EP was based on history, clinical symptoms,  physical examination, a positive serum B-human chorionic gonadotrophin  (B hCG), transvaginal ultrasonography and confirmed at laparoscopy. 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.

 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. 

 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.


 The incidence of ectopic pregnancy (EP) has increased all over the world  from 0.5% thirty years ago, to a present day 1-2%

. 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

. 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 

 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.

. Surgery remains the mainstay of treatment.

. Surgical treatments may be radical (salpingectomy) or conservative  (usually salpingostomy), and they may be performed by laparoscopy or  laparotomy 

. 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.

. 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.

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. 


 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.


 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 litre of lactated Ringer's solution was left in the pelvis at the  conclusion of the operation to help prevent adhesion formation 

. 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 IM every four hours or diclofenac sodium 100 mg, (Rofenac tablets &  ampoules, Spimaco, Saudi Arabia). An outpatient follow up appointment was arranged for four to  six weeks after discharge from hospital.


 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.



 
 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.


 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 

. 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.

. 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 haemoperitoneum 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) (

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 (

 
 The technical advancement in the field of minimal access surgery has  greatly enhanced the possibility of both diagnosing and treating EP  effectively. 

. 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. 

. The frequency of EP in our series was 1.1%.In Abha, Saudi Arabia the incidence of EP was 0.74 per 100 live births 

. In northern Europe between 1976 and 1993 the incidence increased from 11.2 to 18.8 per 1000 pregnancies. 

. In the United Kingdom there are around 11 000 cases of EP per year (incidence 11.5 per 1000 pregnancies)

. Although the present study has not focused on the risk factors of EPs many such well factors have been reported in literature 

. The predisposing factors, which have been  demonstrated in the present study, were almost comparable with those  found in a previous studies.

. The presence of known risk factors can  increase suspicion, but any sexually active woman presenting with  abdominal pain and vaginal bleeding after an interval of amenorrhea has  an EP until proved otherwise 

. In the present study The most important symptoms were  abdominal pain (96%), short period of amenorrhea (89.1%) and vaginal  bleeding (79%). These were comparable with other studies. 

 The study also demonstrated that the most important  signs were abdominal tenderness (89%) and adnexal tenderness (64%). History and physical examination alone do not reliably diagnose  or exclude EP, as up to 9% of women report no pain and 36% lack adnexal  tenderness 

. The usefulness of ultrasound in the study was confirmed by the fact that 86% were confirmed by ultrasound (

).  The presence of an intrauterine pregnancy generally excludes EP,  although other ultrasound findings have to be considered, especially if  symptoms are atypical, severe, or persistent. The use of quantitative  measurement of serum concentrations of B hCG together with transvaginal  ultrasonography has improved the diagnosis of EP. 

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%.

. 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 

 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. 

. 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 

. 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 (

). 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.

. Also it has been shown that conservative surgery is more likely to be performed if the laparoscopic approach is used.

. 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 

. Cornual pregnancies generally require a laparotomy and surgical excision 

; although cases have been successfully managed via the laparoscope 

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 %.

. 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. 

 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 

. 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 

.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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Articles

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.

M. Sherief El Sayes, MD

Articles

Tubal Ectopic Pregnancy: Laparoscopy vs. Laparotomy