Clinical outcomes following interval laparoscopic transadominal cervico-isthmic cerclage placement: Case series

M.J. Mingione, J.J. Scibetta, S.R. Sanko and W.R. Phipps1

Department of Obstetrics-Gynecology, University of Rochester, 601 Elmwood Avenue, Box 668, Rochester, NY 14642, USA

1 To whom correspondence should be addressed. e-mail: William_Phipps{at}URMC.Rochester.edu


    Abstract
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
The purpose of this report is to describe outcomes following laparoscopic transabdominal cervico-isthmic cerclage placement in cases of cervical incompetence not amenable to a conventional transvaginal procedure. We reviewed records of the first 11 patients at an academic teaching hospital who underwent laparoscopic transabdominal cerclage placement as an interval procedure, using a technique we previously first described. For all patients, the clinical course, including surgical complications and outcome of all subsequent pregnancies, is briefly described. One case was complicated by a small bowel injury secondary to concomitant extensive enterolysis. Otherwise there were no complications. Mean estimated blood loss was <40 ml. To date, 10 patients have conceived a total of 12 pregnancies following the procedure. Two pregnancies resulted in spontaneous losses at 8 weeks gestation, two in deliveries by Caesarean section at 34.5 weeks, and eight in deliveries by elective Caesarean section at 38 weeks or more. Each delivery resulted in the birth of a healthy infant. In conclusion, patients who require a transabdominal cerclage may undergo a laparoscopic interval procedure and achieve outcomes similar to those following placement via laparotomy during pregnancy.

Key words: cerclage/cervical incompetence/operative laparoscopy/surgical techniques


    Introduction
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
Since its detailed description nearly four decades ago (Benson and Durfee, 1965Go), many case series have confirmed the value of placing a transabdominal cervico-isthmic cerclage by laparotomy in that small subset of women with cervical incompetence for whom a conventional transvaginal procedure would be inadequate or impossible. In general, the procedure has been done in pregnant women, either towards the end of the first trimester or early in the second trimester, with delivery rates of viable infants consistently in the range of 85–90% (Mahran, 1978Go; Novy, 1991Go; Cammarano et al., 1995Go; Gibb and Salaria, 1995Go; Topping and Farquharson, 1995Go; Craig and Fliegner, 1997Go; Turnquest et al., 1999Go).

In 1998, we described in a case report for the first time the successful use of an interval laparoscopic technique for transabdominal cerclage placement, so as to avoid the need to resort to a laparotomy during the pregnant or non-pregnant state (Scibetta et al., 1998Go). Here we update that initial report by summarizing our results for the first 11 patients who underwent laparoscopic transabdominal cerclage placement at the Strong Memorial Hospital, an academic teaching hospital, between December 1995 and August 2002.


    Case reports
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
The 11 cases described here all involved non-pregnant women with indications for transabdominal cerclage placement as proposed by Novy (1991Go), based on the obstetric history, the details of previous transvaginal cerclage attempts, and current cervical anatomical status. All were performed by the senior surgeon (J.J.S.), who had substantial experience with transabdominal cerclage placement by laparotomy prior to 1995, and who was assisted by another attending physician and/or senior resident. University of Rochester Research Subject Review Board review was not necessary to proceed in this fashion according to institutional guidelines, although in each case informed consent was obtained, and the patient was made aware of the innovative nature of the procedure. All pertinent office and hospital records were reviewed meticulously to provide the data for this report. The specific technique used, described in detail in our previous report (Scibetta et al., 1998Go), is described here more briefly.

Brief description of surgical technique
Under general anaesthesia, the patient is placed in the dorsal lithotomy position, and a Foley catheter inserted. The vaginal wall/cervix is grasped with a tenaculum anterior to the cervical opening, and an 8 mm dilator placed into the cervix and then secured to the tenaculum. A laparoscopy involving four puncture sites is then carried out, using an umbilical incision for the laparoscope trocar. Findings such as endometriosis or adhesions are treated according to individual circumstances.

The peritoneum of the uterovesical reflection is incised transversely with laparoscopic scissors, and the bladder advanced downward. A 5 mm Mersilene polyester fibre ligature, 30 cm in length (RS-21, Ethicon, Inc., Somerville, NJ, USA), is prepared by first removing the swagged needles from the ends, which are each then tagged with a loop of suture material. The ligature is then passed into the pelvis and positioned behind the uterus. A disposable Endo Close suturing device (Auto Suture Company, Norwalk, CT, USA) is then passed into the abdominal cavity, its tip directed toward the lateral aspect of the uterovesical reflection incision on the left. The tip is guided along the isthmus, medial to the left-sided uterine vessels and through the tissue of the cardinal ligament, so as to pierce the posterior leaf of the broad ligament just above the insertion of the uterosacral ligament. The loop at one end of the Mersilene ligature is grasped with the tip of the device, and the device is pulled back anteriorly, bringing with it the ligature. This sequence of events is then repeated on the right side, so as to bring the other end of the Mersilene ligature anteriorly along the isthmus on the right.

After verifying that the ligature is lying flat and snugly against the isthmus posteriorly (Figure 1), the ends of the ligature are tied together anteriorly and excess ligature material is trimmed (Figure 2). The knot is then secured further by tacking each free end to the underlying band, and the peritoneum is sutured over the knot. The pelvis is lavaged with normal saline solution, haemostasis confirmed, and the laparoscopy terminated in the usual manner.



View larger version (132K):
[in this window]
[in a new window]
 
Figure 1. The large arrow shows the ligature lying flatly and snugly posteriorly, above the uterosacral ligament insertions, which are indicated by the smaller arrows.

 


View larger version (137K):
[in this window]
[in a new window]
 
Figure 2. The arrow shows the ligature tied down anteriorly, after excess ligature material has been trimmed. The peritoneum will be sutured over the knot after each free end has been tacked to the underlying band segment.

 

    Results
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
A summary of our cases is presented in Table I, listed in the sequence in which the procedures were performed. In seven cases, the primary indication for transabdominal cerclage was the absence or virtual absence of the entire exocervix, precluding placement of a transvaginal cerclage. In one of these (case 1), there was a history of in utero diethystilboestrol exposure. In another (case 2), a single cone biopsy had been done because of adenocarcinoma in situ, and in another four (cases 3, 4, 7 and 9), two or more cervical cone biopsies had been done because of severe dysplasia and/or carcinoma in situ.


View this table:
[in this window]
[in a new window]
 
Table I. Summary of the course of patients undergoing laparoscopic transabdominal cerclage placement
 
In one case, the entire anterior cervix was absent, on the basis of a cervical injury at the time of a previous vaginal delivery (case 5). In two cases (cases 6 and 10), the cervix was markedly abnormal in appearance, and three prior vaginal cerclage procedures had resulted in unacceptable outcomes. In the remaining case (case 11), there was a history of a single cone biopsy followed by a pregnancy loss at 20 weeks, and the markedly abnormal cervix was judged not suitable for an attempt at transvaginal cerclage placement.

In case 10, the procedure was complicated by an initially unrecognized penetrating small bowel injury that occurred during lysis of extensive adhesions that involved the bowel and uterus and nearly precluded placing the cerclage. Subsequently, the patient developed a pelvic abscess that was treated with computed tomography (CT)-guided drainage and i.v. antibiotics. This patient had previously had a vaginal delivery at 25 weeks gestation and then a classical Caesarean section at 27 weeks (following premature rupture of membranes) despite transvaginal cerclages. These pregnancies were followed by a hospital admission for pelvic inflammatory disease, and then her last pregnancy, which had resulted in a loss at 20 weeks despite another vaginal cerclage. There were no other surgical complications. Mean estimated blood loss for the 11 cases was <40 ml, with a range of 10–100 ml. Mean surgical time (from incision to incision closure) was 68 min, including two cases that included significant concomitant lysis of adhesions (cases 1 and 10, which had surgical times of 85 and 89 min, respectively). The last three cases other than case 10 all had surgical times of <60 min.

Ten of the 11 patients were able to achieve a total of 12 intrauterine pregnancies following cerclage placement, one of which followed embryo transfer of cryopreserved donor oocyte-derived embryos as previously described (Scibetta et al., 1998Go). The only patient not conceiving had, before the surgery, expressed a desire to conceive in the near future, but subsequently changed her mind about this (case 9).

Of the 12 pregnancies, two resulted in losses at 8 weeks gestation, including one in which a suction dilatation and curettage (D&C) was performed for a missed abortion. Of the remaining 10 pregnancies, one resulted in delivery by Caesarean section at 34.5 weeks of gestation because of concern raised by a fetal heart rate tracing demonstrating recurrent deep variable decelerations, and another resulted in a Caesarean section at 34.5 weeks because of severe pre-eclampsia. The other eight all resulted in deliveries by elective Casarean section at 38 weeks or more. All of the infants born were healthy. None of the cerclages have been removed.


    Discussion
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
Outcomes in the 10 pregnancies with known outcomes proceeding past 8 weeks of gestation were uniformly good, comparing favourably with the 85–90% salvage rate reported in most case series involving placement of transabdominal cerclage by laparotomy during pregnancy. It is unlikely that either of the two early losses was related to the cerclage itself. Results similar to ours were reported recently by von Theobald (2002Go), who described five patients undergoing laparoscopic transabdominal cerclage placement as an interval procedure, all of whom in subsequent pregnancies were delivered by Caesarean section at ~38 weeks of gestation. Thus the approach we describe appears to give results comparable with those achieved with the conventional transabdominal approach, with the obvious advantages of avoiding a laparotomy. These advantages very probably include reduced de novo post-operative adhesion formation, which most reproductive surgeons believe is the case for most pelvic surgeries done laparoscopically as opposed to by laparotomy (Johns, 2001Go).

Our outcomes and those of von Theobald (2002Go) also compare favourably with those following a newly described transvaginal approach, more elaborate than the more commonly used Shirodkar or McDonald techniques, that results in a cerclage stated to have characteristics essentially identical to those using a transabdominal approach (Golfier et al., 2001Go). Golfier et al. used this approach in 20 women, primarily as an interval procedure, and reported results for 23 pregnancies in 15 women whose pregnancy extended beyond 16 weeks. Of these 23 pregnancies, there were three losses before 24 weeks, three deliveries of live infants before 34 weeks, and 17 deliveries of live infants after 34 weeks. A possible advantage of the approach used by Golfier et al. compared with ours is that theirs would presumably be more amenable to being done under spinal or epidural anaesthesia, although in fact general anaesthesia was used in all of their cases.

It is of note that both our series and that of Golfier et al. (2001Go) included patients who had no history of either a mid-trimester loss or a premature delivery. Specifically, this was the case for five of our patients (cases 2, 3, 5, 7 and 9), all of whom had cervical anatomy that would have made the placement of a conventional transvaginal cerclage impossible. Similarly, eight of the 20 patients described by Golfier et al. (2001Go) underwent surgery on a ‘prophylactic’ basis, mostly because of an absent exocervix following surgery for cervical cancer. It is quite possible that, especially such patients without prior losses, would have had good obstetrical outcomes without any cerclage, but our five such patients elected to proceed with the surgery because of the perceived risks associated with their anatomy per se.

An obvious disadvantage of our approach, also the case for any interval cerclage procedure, is that a pregnancy progressing past the first trimester may never subsequently occur. This disadvantage could be circumvented by placing the cerclage laparoscopically only after the presence of an ongoing pregnancy is confirmed, but we have been reluctant to do so because of concern about haemorrhage-related complications. As discussed in our earlier report, we continue to believe that the firm nature of the non-pregnant cervical isthmus facilitates the ability of the surgeon to avoid injuring the uterine vessels. In this regard, we are aware of only one published case report of laparoscopic placement of a transabdominal cerclage during pregnancy (Lesser et al., 1998Go). Although the outcome of that case was ultimately favourable, during surgery there was bleeding from the uterine vessels on one side that required the use of haemostatic clips and packing, and operating time was prolonged. Along these same lines, the possibility of excessive bleeding has long been recognized to be problematic when a transabdominal cerclage is placed by laparotomy during pregnancy (Cammarano et al., 1995Go; Zaveri et al., 2002Go), and a decreased risk of bleeding was cited specifically as an advantage for placement in the non-pregnant state in a case series reported in 1997 that involved abdominal cerclages placed by laparotomy in both non-pregnant and pregnant women (Craig and Fliegner, 1997Go).

Assuming the laparoscopic approach we describe is only used for non-pregnant women, the desire to avoid surgery with no benefit warrants restricting the procedure to women reasonably likely to achieve a viable pregnancy. This of course is the case for any intervention, including tubal surgery and conventional IVF, the ultimate purpose of which is to produce a pregnancy. Additionally, as emphasized by Novy (1991Go) and Cammarano et al. (1995Go) for the transabdominal approach in general, it is important to limit the procedure to those cases in which a conventional transvaginal approach is not reasonably likely to be successful. In many cases, depending on individual circumstances, patients with a history of a single or even two failed transvaginal cerclage procedures may still be managed successfully with a repeat transvaginal procedure. Nonetheless, the presence of seemingly adequate cervical anatomy for a repeat transvaginal procedure is only one factor to be considered when a transabdominal approach is also being contemplated. This point of view is supported by a recent study (Davis et al., 2000Go), which retrospectively assessed pregnancy outcomes of patients with prior failed transvaginal cerclages for whom a transvaginal approach was feasible based on cervical anatomy, and specifically compared repeat transvaginal procedures with the conventional transabdominal approach. In that study, the transabdominal group, despite greater numbers of prior failed transvaginal procedures and prior mid-trimester losses, had significantly better outcomes than the repeat transvaginal group.

If an early loss occurs once the cerclage has been placed, the use of a dilator as described allows for the ability of a suction D&C to be performed, as occurred in case 1. In the event of a later loss that requires removal of the cerclage, so as to allow for uterine evacuation from below, consideration should be given to attempting the removal laparoscopically, as described in two case reports (Lesser et al., 1998Go; Scarantino et al., 2000Go) in which a cerclage had been placed by laparotomy during pregnancy.

Overall, our results suggest that a laparoscopic approach prior to pregnancy should be considered as an alternative to laparotomy during pregnancy for patients for whom a transabdominal cerclage is deemed necessary. The technique we describe could be used by any surgeon or surgical team possessing both good laparoscopic surgical skills and experience with transabdominal cerclage placement by laparotomy. Clearly it would be ideal if a randomized study directly comparing our approach with that of Golfier et al. (2001Go) or others was performed in a properly selected population, similar to the recent study of Althuisius et al. (2000Go, 2001), who compared management strategies in cases at lower risk for adverse obstetric outcomes from cervical incompetence. Unfortunately, execution of such a study might be problematic as a practical matter, given the relatively small numbers of women for whom a conventional transvaginal procedure is likely to be inadequate. In any event, hopefully larger series and/or comparative studies confirming our results will be published over the next several years.


    References
 Top
 Abstract
 Introduction
 Case reports
 Results
 Discussion
 References
 
Althuisius, S.M., Dekker, G.A., van Geijn, H.P., Bekedam, D.J. and Hummel, P. (2000) Cervical incompetence prevention randomized cerclage trial (CIPRACT): study design and preliminary results. Am. J. Obstet. Gynecol., 183, 823–829.[CrossRef][ISI][Medline]

Althuisius, S.M., Dekker, G.A., Hummel, P., Bekedam, D.J. and van Geijn, H.P. (2001) Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): therapeutic cerclage with bed rest versus bed rest alone. Am. J. Obstet. Gynecol., 185, 1106–1112.[CrossRef][ISI][Medline]

Benson, R.C. and Durfee, R.B. (1965) Transabdominal cervicouterine cerclage during pregnancy for the treatment of cervical incompetency. Obstet. Gynecol., 25, 145–155.[ISI][Medline]

Cammarano, C.L., Herron, M.A. and Parer, J.T. (1995) Validity of indications for transabdominal cervicoisthmic cerclage for cervical incompetence. Am. J. Obstet. Gynecol., 172, 1871–1875.[CrossRef][ISI][Medline]

Craig, S. and Fliegner, J.R. (1997) Treatment of cervical incompetence by transabdominal cervicoisthmic cerclage. Aust. N.Z. J. Obstet. Gynecol., 37, 407–411.[ISI][Medline]

Davis, G., Berghella, V., Talucci, M. and Wapner, R.J. (2000) Patients with a prior failed transvaginal cerclage: a comparison of obstetric outcomes with either transabdominal or transvaginal cerclage. Am. J. Obstet. Gynecol., 183, 836–839.[CrossRef][ISI][Medline]

Gibb, D.M. and Salaria, D.A. (1995) Transabdominal cervicoisthmic cerclage in the management of recurrent second trimester miscarriage and preterm delivery. Br. J. Obstet. Gynecol., 102, 802–806.[ISI][Medline]

Golfier, F., Bessai, K., Paparel, P., Cassignol, A., Vaudoyer, F. and Raudrant, D. (2001) Transvaginal cervicoisthmic cerclage as an alternative to the transabdominal technique. Eur. J. Obstet. Gynecol. Reprod. Biol., 100, 16–21.[CrossRef][ISI][Medline]

Johns, A. (2001) Evidence-based prevention of post-operative adhesions. Hum. Reprod. Update, 7, 577–579.[Abstract/Free Full Text]

Lesser, K.B., Childers, J.M. and Surwit, E.A. (1998) Transabdominal cerclage: a laparoscopic approach. Obstet. Gynecol., 91, 855–856.[Abstract/Free Full Text]

Mahran, M. (1978) Transabdominal cervical cerclage during pregnancy. A modified technique. Obstet. Gynecol., 52, 502–506.[Abstract]

Novy, M.J. (1991) Transabdominal cervicoisthmic cerclage: a reappraisal 25 years after its introduction. Am. J. Obstet. Gynecol., 164, 1635–1642.[ISI][Medline]

Scarantino, S.E., Reilly, J.G., Moretti, M.L. and Pillari, V.T. (2000) Laparoscopic removal of a transabdominal cervical cerclage. Am. J. Obstet. Gynecol., 182, 1086–1088.[CrossRef][ISI][Medline]

Scibetta, J.J., Sanko, S.R. and Phipps, W.R. (1998) Laparoscopic transabdominal cervicoisthmic cerclage. Fertil. Steril., 69, 161–163.[CrossRef][ISI][Medline]

Topping, J. and Farquharson, R.G. (1995) Transabdominal cervical cerclage. Br. J. Hosp. Med., 54, 510–512.[ISI][Medline]

Turnquest, M.A., Britton, K.A. and Brown, H.L. (1999) Outcome of patients undergoing transabdominal cerclage: a descriptive study. J. Matern. Fetal Med., 8, 225–227.[CrossRef][Medline]

von Theobald, P. (2002) Le cerclage isthmique par coelioscopie. J. Gynecol. Obstet. Biol. Reprod. (Paris), 31, 273–275.[Medline]

Zaveri, V., Aghajafari, F., Amankwah, K. and Hannah, M. (2002) Abdominal versus vaginal cerclage after a failed transvaginal cerclage: a systematic review. Am. J. Obstet. Gynecol., 187, 868–872.[CrossRef][ISI][Medline]

Submitted on February 5, 2003; accepted on May 9, 2003.