Laparoscopic salpingotomy for tubal pregnancy: comparison of linear salpingotomy with and without suturing

Akira Fujishita1,2, Hideaki Masuzaki1, Khaleque Newaz Khan1, Michio Kitajima1, Koichi Hiraki1 and Tadayuki Ishimaru1

1 Department of Obstetrics and Gynecology, Nagasaki University School of Medicine, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan

2 To whom correspondence should be addressed. e-mail: fujisita{at}net.nagasaki-u.ac.jp


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
BACKGROUND: The study was carried out to clarify the incidence of post-operative tubal adhesions, patency rate and pregnancy outcome after laparoscopic salpingotomy with and without suturing for tubal pregnancy. METHODS: From May 1996 to December 2002, a total of 97 cases of tubal pregnancy were treated in our centre by laparoscopic conservative surgery. The successful salpingotomy cases were randomly assigned to undergo salpingotomy without suturing (group I; n = 43) or with suturing (group II; n = 32). We compared these patients and assessed their surgical and pregnancy outcome by second look laparoscopy (SLL) 3 months after the first operation. RESULTS: Seventy-five cases (77%) were treated successfully by salpingotomy at initial laparoscopic surgery, and the remaining 22 cases were unsuccessful because of bleeding or complete tubal damage. Pelvic findings were assessed at SLL in 21 of 43 cases (49%) in group I and 17 of 32 (53%) in group II. There were no significant differences in gestational age, ectopic site, tubal diameter, tubal condition, intraperitoneal haemorrhage and pre-operative HCG levels between the two groups. Only the operation time was longer in group II than in group I (91 ± 15 versus 69 ± 15 min, P < 0.05). The tubal patency rate of the treated side was 90% (19/21) in group I and 94% (16/17) in group II. Also the peritubal adhesions were observed in 33% (7/21) in group I and 29% (5/17) in group II, and were mostly comprised of filmy adhesions. A tubal fistula occurred in two cases in each group. Pregnancy rate was 79% (15/19) in group I and 92% (12/13) in group II, and this did not reveal any significant difference of cumulative pregnancy rate between the groups. CONCLUSION: We recommend laparoscopic linear salpingotomy as a useful method in the management of cases with tubal pregnancy who desire future pregnancy. This preliminary study emphasizes that the procedure involving suturing has no additional benefit over the non-suturing technique during salpingotomy.

Key words: ectopic pregnancy/laparoscopy/linear salpingotomy/second look laparoscopy/suturing


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Bruhat et al. (1980Go) were the first to describe a method for conservative laparoscopic surgery for ectopic pregnancy. Since then, the technical developments have been substantial and today the technique includes both radical treatment and various conservative pharmacological management strategies (Pouly et al., 1986Go; Mecke et al., 1989Go; Lindblom et al., 1990Go; Lang et al., 1992Go; Fernandez et al., 1998Go). In women who wish to preserve future fertility, conservative surgery by linear salpingotomy is considered the gold standard for the management of ectopic pregnancy. Laparoscopic conservative surgery has been reported to have advantages in terms of efficacy, safety, cost and subsequent reproductive outcome in comparison with laparotomic surgery (DeCherney et al., 1987Go; Lavy et al., 1987Go; Vermesh., 1989Go; Clasen et al., 1997Go; Yao and Tulandi, 1997Go; Hajenius et al., 2000Go).

It is also important to consider the closure of the tubal incision after linear salpingotomy. Previous reports have discussed the cumulative pregnancy rate in laparotomy cases (DeCherney and Kase, 1979Go, De Cherney et al., 1981Go; Reich et al., 1987Go; Tulandi and Guralnick, 1991Go; Vermesh and Presser, 1992Go). We started laparoscopic salpingotomy in our department in 1993, and we usually keep the salpingotomic wound open without suturing at the initial stage. However, more recently Kawauchi et al., 1994Go, personal communication, it has been suggested that suturing may be superior to not suturing after laparoscopic salpingotomy, in order to reduce the post-surgical tubal adhesions. According to our initial attempts, we seldom experienced tubal adhesion after laparoscopic salpingotomy without suturing as observed at any second surgery. These pleasing surgical findings in favour of a non-suturing procedure prompted us to analyse the conflicting idea of whether the suturing procedure is truly necessary for laparoscopic salpingotomy in the management of tubal pregnancy.

To our knowledge, there has been no prospective randomized study on the adhesion rate, chromopertubation results of ipsilateral tubal patency by second look laparoscopy (SLL) and follow-up fertility outcome after suturing and non-suturing procedures during linear salpingotomy. Therefore, the present study was undertaken to compare the adhesion formation of tubes, tubal patency rate and reproductive outcome after laparoscopic conservative surgery for ectopic pregnancy by salpingotomy with suturing versus without suturing.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Patient selection
During the 79 months from May 1996 to December 2002, we performed conservative laparoscopic surgery in a total of 103 cases of ectopic pregnancies in our hospital. We selected laparoscopic salpingotomy on the basis of following criteria: (i) the patients’ desire for future pregnancy; (ii) haemodynamically stable women; (iii) no signs of active bleeding; and (iv) no severe adhesions in the tubal wall. Any cases with interstitial pregnancy, ovarian pregnancy and abdominal pregnancy were excluded from this study. Finally, 97 tubal pregnancies were treated by laparoscopic salpingotomy during this period (Figure 1).



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Figure 1. Flow chart diagram of the study. Six out of 103 women were excluded because of non-tubal pregnancy. Ninety-seven women with tubal pregnancy treated by laparoscopic linear salpingotomy initially were entered in this protocol, but 22 patients were excluded due to unsuccessful outcome at surgery. In total, 75 patients with tubal pregnancy were randomized into two groups. Twenty-one (group I) of 43 patients with laparoscopic salpingotomy without suturing agreed to second look laparoscopy (SLL). Seventeen (group II) of 32 patients with laparoscopic salpingotomy with suturing could be assessed by SLL.

 
We prospectively randomized our study for tubal pregnancy by computer generated randomization list in which salpingotomy cases without suturing were compared with those with suturing. We recommended SLL at 3 months after the first operation to identify the difference in early adhesion formation. When patients did not accept SLL, we examined tubal patency by hysterosalpingography (HSG). This study was approved by the Medical Ethical Committee of Nagasaki University School of Medicine. A pre-operative informed consent was obtained from all women after explaining to them the possible risks and complications of conservative procedures such as persistent ectopic pregnancy and repeated tubal pregnancy. If tubal damage precluded a linear salpingotomy, a radical management such as segmental resection or salpingectomy was performed as appropriate.

Surgical procedure
The laparoscopic procedure was perfomed according to that previously described by Pouly (1986Go) and Tulandi and Saleh (1999Go). Briefly, usually two operating trocars (5 mm) were inserted by means of lateral supra-pubic incisions, but in the cases of salpingotomy with suturing, a 5 mm supra-pubic ancillary puncture site was used. In the case of haemoperitoneum, aspiration and washing of the pelvis was done with saline solution under pressure using the Hamou Endomat (Karl Storz Endoscopy-Japan Inc.). Evaluation of the tubal site for operation and measurement of the lengthwise and crosswise extension of swelling tubes was done using a 5 mm probe (deflecting palpation probe; catalogue no. 26173T, Karl Storz Endoscopy-Japan Inc.).

In order to prevent haemostasis, vasopressin (Pitressin; Sankyo Co. Ltd Japan) was diluted in 4 ml of saline solution and injected into the mesosalpinx through a 22 gauge needle (Peti-needle; Hakko Co. Ltd, Japan). A 10–20 mm incision for linear salpingotomy was made in the anti-mesenteric proximal portion of the haematosalpinx using a fine-tip needle cautery or knife electrode (Karl Storz Endoscopy-Japan Inc.). The irrigation and suction tube (5 mm) was introduced through the salpingotomy incision, and all clots and trophoblastic tissues were aspirated. In most cases, aspiration removed the product of conception entirely. In some cases, saline solution was injected under high pressure with the Hamou Endomat or grasping forceps, in an attempt to separate the trophoblast from the tubal wall.

In group I, the salpingotomy wound was left open; however, in group II, we closed the incision in one layer by one or two interrupted sutures using absorbable stitches (no. 3-0 vicryl: catalogue no. E9903S, Johnson & Johnson Medical Co. Ltd, Japan). Surgical specimens were generally withdrawn through the 5 mm trocar sleeve after grasping the tissue and passing through the operating channel of the laparoscope. We removed all clots and products of conception, and we assessed the contralateral Fallopian tube. If any bleeding or oozing of blood from inside the lumen or tubal wall occurred, or the procedure was associated with complete tubal damage, such cases with salpingotomy were switched to salpingectomy.

Statistical analysis
Data were analysed by using either a Student’s t-test, Wilcoxon rank sum test or {chi}2 test. If we assumed that the adhesion rate in group II was 50% and it could be reduced to 25% in the non-suturing group, the required sample size was ~50 patients in each group with {alpha} and {beta} errors of 0.05 and 0.20, respectively. In the event of pregnancy, the cumulative pregnancy rate was calculated by the inverse curve analysis of the Kaplan–Meier methods and the difference between curves was evaluated by log-rank test. A value of P < 0.05 was considered as significant. All data are expressed as means ± SD.


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
Of 103 cases with ectopic pregnancy, six cases with other ectopic sites, such as interstitial pregnancy (n = 3), ovarian pregnancy (n = 2) and abdominal pregnancy (n = 1), were excluded. Twenty-two cases of tubal pregnancy were treated unsuccessfully at initial surgery; thus 75 cases were randomized to receive either a suturing procedure (n = 32) or no suturing (n = 43). We could assess the tubal findings at SLL in 21 cases (group I) of salpingotomy without suturing and in 17 cases (group II) with suturing. Another 28 cases did not accept SLL and were assessed by HSG. A further nine patients were lost to follow-up.

Table I shows the clinical and labolatory data in each group. There was no difference between the two groups in patient age, gravidity, parity, gestational age, history of ectopic pregnancy or tubal microsurgery, pelvic inflammatory disease, infertility and Chlamydia infection rate. There was also no difference between the distribution of anatomic location of the ectopic pregnancy in the two groups (Table I). Tubal rupture was observed in one case in each group, and these ruptured cases displayed a small ruptured hole and there was no massive bleeding. We tried to approach these cases by conservative surgery. As shown in Table I, we did not observe any difference in the mean maximum diameter of the ectopic pregnancy and the mean volume of intraperitoneal haemorrhage between the two groups. The only significant difference observed was in the operation time, which as expected was longer in group II (91 ± 15 min) compared with group I (69 ± 15 min) (Student’s t-test, P < 0.05). Although the mean concentration of pre-operative urinary and serum HCG levels was higher in group I than in group II, the difference was not significant (Wilcoxon test).


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Table I. Clinical and laboratory data in each group
 
The surgical outcome and SLL findings in groups I and II are shown in Table II. Persistent ectopic pregnancy occurred in one case of group I but none of group II. This case was treated with methotrexate (MTX) injection (20 mg i.m. for 4 days) with a consequent smooth decline of HCG levels. Endometriosis was seen in two cases in group I and one in group II. The tubal patency rate of the treated side was 90% (19/21) in group I and 94% (16/17) in group II; the peritubal adhesion rate was 33% (7/21) in group I and 29% (5/17) in group II. Most of these adhesions were filmy and would be classified as less than three points according to the AFS classification score (American Fertility Society, 1988Go). Adhesiolysis was very easy at SLL. On the other hand, the contralateral tubal patency rate was 80% (16/20) in group I and 94% (15/16) in group II. In the contralateral tube, the peritubal adhesion rate was 5% (1/20) in group I and 6% (1/17) in group II.


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Table II. Treatment outcome and SLL findings in each group
 
Interestingly, we observed a tubal fistula in two cases in each group. The fistula hole was very small with a slight reddish change on the surface. We did not perform any surgical treatment during SLL for the fistula. The pregnancy rate was 79% (15/19) in group I and 92% (12/13) in group II (Table II). We observed 12 intrauterine pregnancies (with a viable fetus), one abortion and two repeated ectopic pregnancies in group I; and 10 intrauterine pregnancies, one abortion and one repeated ectopic pregnancy in group II during the follow-up period of 6–65 months.

The cumulative pregnancy rates at 12 and 24 months follow-up were 44 and 69% in group I, and 39 and 54% in group II, respectively. There was no statistically significant difference in cumulative pregnancy rate between group I and group II (P = 0.33, log-rank test, Figure 2). Most of the pregnancies occurred within 12 months after SLL. One case, complicated with male factor in group I, was conceived by artificial insemination using the husband’s sperm at 24 months after SLL. Also, one case of group II was conceived at 30 months after IVF. Repeated tubal pregnancy occurred in a total of three cases in the combined groups I and II, and all repeated tubal pregnancies occurred in the ipsilateral tube.



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Figure 2. The cumulative pregnancy rate in the salpingotomy without suturing (solid line, group I) and with suturing (dashed line, group II) groups as evaluated in the follow-up period. The inverse curve analysis of pregnancy outcome was calculated by Kaplan–Meier methods and log-rank test and indicated no significant difference in the pregnancy rate between them (P = 0.33).

 

    Discussion
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
The diagnosis and management of ectopic pregnancy has changed dramatically with the technical advances in sensitive assays for HCG and widespread use of transvaginal sonography. As a result, ectopic pregnancy can be identified early, and medical or surgical therapy can be given promptly.

Many treatment options are now available to the clinician for the management of tubal pregnancy: surgical treatment, which can be performed radically or conservatively, either laparoscopically or by an open surgical procedure; medical treatment with a variety of drugs; or expectant management. We practised conservative management as a first choice by MTX or MTX suspension under laparoscopic guidance until 1993 (Fujishita et al., 1995Go). However, MTX therapy has some disadvantages such as inadequately declining HCG concentration after MTX injection, and the requirement for additional MTX injection or surgical interventions. In addition, the Japanese insurance system does not permit this drug for ectopic pregnancy therapy in general practice, and women with ectopic pregnancy tend to reject MTX therapy because of its side effects.

Since 1993, laparoscopic surgery for ectopic pregnancy has been widely adopted by the health insurance system in Japan. Since then, we have practised laparoscopic salpingotomy as the first choice for surgery in patients who want a future pregnancy. When we started laparoscopic salpingotomy as conservative surgery, we routinely left the linear salpingostomic wound open (no suturing), because we did not have a sufficiently skillful suturing technique at that time. The most important issue involves closure of the tubal incision after linear salpingotomy. The edges of the incision can be either closed at the time of open surgery or left to heal by secondary intention.

DeCherney and Kase (1979Go) either closed the incision in two layers or left the incision open and employed a running locked suture for haemostasis. Semm (1982Go) described a laparoscopic method of reapproximation with an Ethi-endosuture using the extracorporeal knot. Bruhat et al. (1980Go) preferred to leave the tubal incision open. Reich et al. (1987Go) initially used Klepinger bipolar forceps to pinch the cut ends together; however, they later abandoned this technique in favour of Bruhat’s method. Nelson et al. (1986Go) compared primary and secondary closure of ampullary salpingotomy in the rabbit and found no statistically significant difference in subsequent pregnancy rate, nidation indices or percentage of adhesions. Tulandi and Guralnick (1991Go) compared salpingotomy with tubal suturing versus without tubal suturing. No significant differences were found in the number of subsequent intrauterine pregnancies and repeat ectopic pregnancies. Based on these data, it seems reasonable to speculate that primary closure of the tubal wall is unnecessary.

However, most of these reports were undertaken by open surgery and there were no comments in the literature on the necessity of suturing in cases of laparoscopic salpingotomy. Moreover, no prospective randomized study had been done to assess the reproductive outcome by SLL. Therefore, we planned this research to investigate the post-operative tubal adhesions and patency rate after laparoscopic salpingotomy in two groups of patients, with and without suturing. Our results indicated that the tubal patency rate and adhesion rate were not different between the groups. The cumulative pregnancy rate was also almost the same in both groups. Thus it is not always necessary to suture the incision line after linear salpingotomy or lapatotomic salpingotomy.

We believe that our study has some limitations and it is premature to conclude definitely regarding our findings because of the small sample size and small incision length. If the length of linear salpingotomy is >2 cm, suturing may be necessary, which was not examined in this study, as most of our incision lengths were within 2 cm at linear salpingotomy.

Regarding reproductive outcome, the intrauterine pregnancy rate was 77.4% (24/31), and recurrent ectopic pregnancy was 9.7% (3/31) in this series. Based on a review of 1514 patients attempting to conceive after linear salpingotomy, the intrauterine pregnancy rate and recurrent ectopic pregnancy rate were reported to be 61.4 and 15.4%, respectively, among patients who had the procedure performed by laparotomy, and 61 and 15.5%, respectively, in patients who had the procedure performed by laparoscopy (Yao and Tulandi, 1997Go). The high percentage of tubal patency as observed in this study may be due to follow-up assessment by SLL instead of the usual HSG test. In general, SLL has a relatively higher sensitivity and specificity than HSG. In the patients who strongly desire to conceive, we may recommend these patients for conservative surgery to accept SLL (Lundorff et al., 1990Go).

In this study, we found four cases of fistula after laparoscopic linear salpingotomy. The incidence rate was 9.5% (2/21) in salpingotomy without suturing versus 11.8% (2/17) in salpingotomy with suturing and there were no significant difference between these two groups. In the failure of tubal closure following laser salpingotomy for ampullary pregnancy, one report described that another ectopic pregnancy occurred in the tubal defect part (Cropp et al., 1987Go). The incidence and aetiology of this defective healing of salpingotomy are not known.

Pouly et al. (1986Go) have reported their experience with conservative laparoscopic treatment of 321 ectopic pregnancies. SLL was performed in 18 patients to assess tubal healing, and all salpingotomy sites were covered by serosa. Lundorff et al. (1990Go) reported 102 women with ectopic pregnancy who underwent SLL 6–10 weeks after first ectopic pregnancy surgery. The author reported the failure of tubal closure after salpingotomy with leakage in five cases. When such fistulas are present, repeated tubal pregnancy may occur at the fistula site, or it may increase the risk of defective ovum transport or a complication of abdominal pregnancy. In our four cases, all cases conceived by an intrauterine pregnancy and there was no case of repeat ectopic pregnancy and/or abdominal pregnancy. These fistula may be difficult to examine by HSG, and we first recognized this kind of fistula by SLL and by applying the chromopertubation test. Thus routine practice of SLL may be useful in finding such complications in future.

Laparoscopic treatment of ectopic pregnancy has been advocated for >20 years (Bruhat et al., 1980Go). The majority of women with ectopic pregnancy still undergo emergency laparoscopy. However, only 29% of hospitals had a formal policy to treat ectopic pregnancy by laparoscopy as a routine procedure in the UK (Ghosh et al., 1999Go). Laparoscopic surgery for ectopic pregnancy has been gradually spreading in Japan, but there are still some problems in the ability of hospitals in the regional areas to practise this surgery. The laparoscopic suturing technique is not difficult for many gynaecological specialists or laparoscopic surgeons. However, laparoscopic specialists do not always perform the laparoscopic salpingotomies. In this study, a 20 min difference in operating time was observed between suturing and not suturing. In fact, it typically took ~10 or 20 min for the laparoscopic suturing in 1996, at the beginning of this study, whereas now it takes just a few minutes for a skillful laparoscopic surgeon to complete the suturing technique.

The rapid evolution of endoscopic surgery and the prospect of its wider dissemination into different hospitals no longer permits the luxury of the surgeon to be self-taught. If the surgeon decides to perform laparoscopic salpingotomy for ectopic pregnancy as a conservative method, it can be remembered that suturing technique does not affect the adhesion and future pregnancy rate compared with the non-suturing technique. In conclusion, it is not necessary to apply laparoscopic suturing following linear salpingotomy to improve the surgical or reproductive outcome. For general practice, even in remote clinics, laparoscopic salpingotomy without suturing can be recommended in the successful management of ectopic pregnancy.


    References
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 References
 
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Submitted on October 3, 2003; accepted on January 8, 2003.





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