The article we are discussing today is an open-label, multi-center, randomized controlled trial comparing salpingotomy versus salpingectomy in women with tubal pregnancy. It was done by the European Surgery and Ectopic Pregnancy Study Group, and published in The Lancet recently. The aim of this study was to investigate if salpingotomy, which conserves the fallopian tube, improved later pregnancy by natural conception compared to the salpingectomy. This was a multi-center ICT involving hospitals in the Netherlands, Sweden, UK, and USA.
Participants were women aged 18 years and older who fulfilled the following three criteria. Firstly, they had to have a presumptive diagnosis of tubal pregnancy, based on transvaginal sonography with serum hCG, which was subsequently confirmed at surgery. Secondly, their condition had to be amenable to either treatment intervention. If tubal rupture was present, the women were still eligible for the trial, as long as the tubal rupture did not affect the possibility of doing a salpingotomy. Thirdly, they had to have a healthy contralateral tube.
Women with contralateral tubal occlusion, or hydrosalpinx documented at a previous hysterosalpingography or laparoscopy, but unlikely to be pregnant in future if the assigned treatment was salpingectomy, and were thus excluded. During surgery, randomisation to either salpingectomy or salpingectomy was done via a central internet-based program running a computer-generated randomization sequence. Randomization was stratified by hospital, age, and history of tubal disease, whether they had previous ectopic pregnancy, tubal surgery, or pelvic inflammatory disease. The study was open-label, as patients and data analysts were not masked to the assigned intervention. If the assigned treatment was salpingotomy, the technique of linear salpingotomy was used, while salpingectomy, all techniques were allowed. To assess fertility after surgery, researchers contacted the participants by telephone, e-mail, or postal mail every six months for 36 months.
Participants completed a questionnaire about the occurrence and outcome of subsequent pregnancies, until an ongoing pregnancy occurred. The primary outcome was ongoing pregnancy by natural conception. Ongoing pregnancy was defined as either an intrauterine pregnancy visible on ultrasound at a gestational age of 12 weeks or more, with fetal cardiac activity, or a pregnancy that resulted in a live birth. The time to the first ongoing pregnancy in months was measured from the date of surgery to the first day of the last natural period, before the conception that let the ongoing pregnancy.
There were three secondary outcomes-- first, persistent trophoblasts, defined as rising or plateauing serum hCG concentrations post-operatively, that necessitated systemic methotrexate or surgical intervention. Second, repeat ectopic pregnancy, which was defined as any ectopic pregnancy or a persistent pregnancy of unknown location, for which surgery or medical treatment of methotrexate was necessary. Lastly, the first ongoing pregnancy after assisted reproductive therapy, which included ovulation induction, intrauterine insemination, or IVF.
I will now present a summary of the results from the study. A total of 446 women were recruited for the study, out of which 215 were randomly assigned to receive salpingotomy, while salpingectomy were randomly assigned to receive salpingectomy. Of the 215 women who were assigned to salpingotomy, only 164 underwent the same procedure, as the remaining 51 had to be converted eventually to salpingotomy.
The subsequent analysis of the study was done based on intention to treat rather than per protocol. The statistical power of the study was deemed to be sufficient, as only 404 women are needed for a power 80%, but the study was able to recruit more than this number. This table shows the study participant profiles. Of note, the top two risk factors for tubal disease are firstly, previous TOP, and secondly, history of chlamydia.
Meanwhile, the main symptom participants presented with were pelvic pain and PVD. And finally, unsurprisingly, the majority of participants had tubal pregnancies that were located at the ampulla. Overall, we can see that the profiles of both intervention groups were virtually identical. This table shows a subgroup analysis of the participants, which was done based on age, history of previous ectopic pregnancy, pre-operative serum hCG, and size of ectopic mass on ultrasound. The analysis was done to determine if these characteristics changes once [INAUDIBLE] T rate response to salpingectomy versus salpingotomy. Nonetheless, based on the interaction p value shown here, which are all above 0.05, we can see that these characteristics have no statistically significant interaction with the procedures chosen. This justifies the study's current patient selection criteria, which does not specifically select for the listed characteristics. This is a graph that shows the primary outcomes of the study.
The x-axis shows the time after a random assignment. The y-axis shows cumulative ongoing pregnancy rate in percentages. The red line is salpingectomy, and the blue line is salpingotomy.
For the first 18 months, pregnancy rates are slightly higher in the salpingectomy group, but thereafter, pregnancy is slightly higher in the salpingotomy group. Ultimately, after 36 months, the cumulative rate of ongoing pregnancy by natural conception was 60.7% for the salpingotomy, versus 56.2% for the salpingectomy group. However, this difference was not statistically significant, as the log rank p value was 0.678. Meanwhile, in terms of secondary outcomes, which includes adverse events such as persistent trophoblast and repeat ectopic pregnancy, there is statistically significantly more risk for persistent trophoblast for salpingotomy compared to salpingectomy, with a p value of 0.01. However, there was no statistically difference in risk for repeat ectopic pregnancy between the two procedures. In terms of other adverse events, salpingotomy was noted to be associated with higher incidences, as well. Of note, a higher percentage of patients undergoing salpingotomy required blood transfusion, compared to salpingectomy, implying increased blood loss associated with salpingotomy.
In addition, there is also a generally higher percentage of readmissions in the salpingotomy group, compared to that of the salpingectomy group. Causes for readmissions include suspected bleeding and persistent trophoblasts. Readmissions are undesirable, as they increase the cause of health care and cause undue distress to patients. Recognition of these adverse events are important, as we need to counsel patients about the potential adverse effects while they are deliberating between a choice of salpingotomy versus salpingectomy. In addition to evaluating the research paper, we did a literature review on the topic.
Evidence in this field is limited. We managed to find four retrospective studies and a randomized controlled trial. This perspective cohort study done in 1993 looked at 95 patients who underwent laparoscopic surgery for ectopic pregnancy. No significant difference in intrauterine pregnancy rates between the salpingotomy groups and salpingectomy was observed. This next cohort study done in France had 155 women followed up for at least six months post-treatment for ectopic pregnancy. Similarly, no significant difference in intrauterine pregnancy rates was found when comparing the conservative and radical surgery.
Another retrospective cohort study in 1998 compared 56 patients who underwent conservative surgery to 79 patients who underwent radical surgery. We managed to show a significantly higher intrauterine pregnancy rate in the group treated with conservative surgery. This last retrospective cohort study looked at 276 patients who underwent either salpingectomy or tubotomy, aka, salpingotomy. They also found significantly higher intrauterine pregnancy rates in the salpingotomy group. The only randomized controlled trial we found, known as the DEMETER randomized trial, was published recently. Essentially, the trial had two comparisons going on at the same time, radical treatment versus conservative surgery, and conservative versus radical surgery.
We are interested in the latter comparison, which had 230 patients reported. The trial showed no significant difference in two year intrauterine pregnancy rates, when comparing salpingotomy to salpingectomy. However, we should note that unlike that ESEP study, patients in this trial who underwent the conservative surgery were administered a dose of intramuscular methotrexate. This slide shows a summary of the latest evidence we found on this topic. Salpingotomy was first adopted based on assumptions of better fertility, since the tube is preserved. The four cohort studies we presented showed that salpingotomy only had marginal benefits over salpingectomy, in terms of intrauterine fertility rates. The DEMETER trial in 2013 failed to demonstrate any difference in fertility between the salpingotomy and salpingectomy arms.
In view of the available evidence, NICE and RCOG guidelines suggest offering salpingectomy for ectopic pregnancy, unless patients have other risk factors for infertility, such as contralateral tube damage. Clinicians should also inform patients about the potential need for further treatment of persistent trophoblasts and future ectopic pregnancy in the conserved tube. We thought that there could be more inclusion of other factors pertaining to fertility, in addition to having healthy contralateral tubes. Other factors, such as PCOS, endometritis, and smoking can all contribute to subfertility. This study did not explore the possible behavioral changes to sexual intercourse after treatment for ectopic pregnancy. Comparing ESEPs to other studies, there are more patients recruited than the DEMETER study.
As mentioned before, the salpingotomy arm in ESEP is not confounded by an additional dose of IM methotrexate. The results in this trial are consistent with the DEMETER study. In conclusion, salpingectomy should be preferred to salpingotomy in women with tubal pregnancy and a healthy contralateral tube for the following reasons. There is no difference in fertility rates between salpingectomy and salpingotomy, and there are less adverse effects of salpingectomy, namely persistent trophoblasts, blood loss, and readmission rates. In view of the possibility of a marginal benefit of salpingotomy, women who want to maximize pregnancy prospects can still opt for salpingotomy.
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