Abstract
Abstract
Objective:
Transvaginal myomectomy is the mainstay of treatment for prolapsed pedunculated submucosal myoma. This research was conducted to evaluate the outcome of transvaginal removal of clinically diagnosed prolapsed myomas in an office-based versus an operating-room (OR) setting.
Materials and Methods:
This was a retrospective cohort study of all patients with prolapsed myomas treated at a single university hospital during 2008–2016.
Results:
A total of 76 patients with prolapsed myomas were included in this study. All patients were managed with transvaginal myomectomy, which was performed in the OR in 53 (70%) patients and in the office in 23 (30%). The main presenting symptoms were abnormal uterine bleeding (85%) and abdominal pain (19%) and did not differ between the groups. Patients treated in the office tended to have thinner myoma pedicles (<2 cm, 90% versus 41.4%; p = 0.007). The success rate—defined by complete myoma removal—was higher in the OR group (98.1% versus 82.6%; p = 0.01). Among patients treated in the office, abdominal pain was associated with procedural failure (50% versus 5%; p < 0.02). Only 1 patient (1.3%) required hysterectomy for symptomatic uterus myomatosus that occurred 3 years after the transvaginal myomectomy.
Conclusions:
This preliminary study supports management of clinically suspected prolapsed myoma in an OR setting. In patients with thin myoma pedicles coupled with the absence of abdominal pain, in-office removal can be considered due to its associated safety and high success rate in this subset of patients.
Introduction
Uterine fibroids can be found partially or totally intramural, subserosal, or submucosal per the International Federation of Gynecology and Obstetrics classification. 1
The majority of patients with uterine fibroids are asymptomatic, and, thus, fibroids are often diagnosed during routine gynecologic or sonographic examinations. 2 Symptomatic patients typically complain of heavy and prolonged bleeding, dysmenorrhea, or noncyclic pelvic pain. 3
In women who underwent surgery for leiomyomas, 2.5% had pedunculated submucosal myomas. 4 Rarely, these myomas may extrude progressively from the uterine cavity. A prolapsed pedunculated myoma is also known as a “myoma nascens” (born myoma). The main complication of this condition is necrosis of the myoma due to insufficient blood supply through the long pedicle.5,6
Prolapsed myomas collectively represent a separate entity regarding diagnosis and treatment. The diagnosis is accomplished by visualization and palpation during pelvic examination, and transvaginal myomectomy is the mainstay treatment approach. The removal procedure includes grasping the myoma using forceps, and excision of the myoma by twisting it around its pedicle under direct vision.6,7 However, a large broad-based pedunculated myoma can bleed heavily and pose a risk for uterine inversion during removal, which could lead to an emergency hysterectomy. 8 Therefore, these procedures are usually performed in the operating room (OR).
Transvaginal myomectomy of a prolapsed myoma in an office-based setting has been scarcely mentioned in the medical literature, 9 with no data available regarding the safety and the efficacy of this therapeutic approach.
Given the paucity of literature, the goal of this study was to compare the clinical courses and outcomes of clinically diagnosed prolapsed myomas treated in the office versus in the OR.
Materials and Methods
Patients
This was a retrospective cohort study. The study group comprised all patients diagnosed with prolapsed pedunculated submucosal myomas referred to our center (Assaf Harofeh Medical Center) between November 2007 and November 2016. The presumptive diagnosis of a prolapsed myoma was performed by visualization and palpation during pelvic examination. Patients found to have cervical myomas were excluded.
Surgical procedure
During the study period, the decision regarding utilization of transvaginal myomectomy for treating prolapsed myomas in an office setting or in an OR, and the myomectomy itself, were made by 5 senior gynecologists. All of the senior physicians were equally skilled in both techniques.
The in-office procedure was offered to patients who met the following criteria:
The patient had hemodynamic stability. The patient had sufficient pain tolerance to withstand the discomfort of an in-office procedure without anesthesia, with a baseline visual analogue scale (VAS) The patient had a myoma pedicle that was amendable to twisting off. Size of the lesion was not a restriction factor.
According to our department protocol, the in-office procedure is performed only when there is an available OR and dilatation-and-curettage equipment for cases of excessive or massive bleeding.
Data collection
For this study, emergency room (ER) encounters, hospital admissions. and outpatient clinic follow-up visits were abstracted from departmental electronic medical records. The following data were extracted for each patient: demographics; medical and gynecologic history; presenting symptoms and signs; physical examination findings; complete blood count; and imaging studies. The time lapsed from the onset of symptoms until each patient first presented at the clinic or ER were also calculated. In addition, intraoperative findings, postoperative course, and final histologic reports were also reviewed. The study protocol was approved by the institutional review board.
Statistical analysis
Patient characteristics were described as proportions for categorical variables and as means and standard deviation for continuous variables. Significance between groups was assessed by the χ2 square test and Fisher's exact test for categorical variables and the Mann–Whitney-U test, a nonparametric test for continuous variables without normal distribution. A 2-sided p-value <0.05 indicated statistical significance. The data were analyzed using the Software Package for Statistics and Simulation (IBM SPSS, version 23, IBM Corp., Armonk, NY).
Results
During the study period, 81 patients diagnosed with prolapsed myomas were identified. Five patients underwent removal procedures elsewhere and were thus excluded, with 76 patients comprising the final cohort. The mean age was 48.3 ± 10.7 years, with a range of 22 to 73 years. The background characteristics of patients are summarized in Table 1.
Baseline & Clinical Characteristics & Outcomes in Relation to Operative Approach
Bold denotes significant findings.
OR, operating room.
All patients were managed with transvaginal myomectomy, which was performed in the OR in 53 (70%) patients and as an in-office procedure in 23 patients (30%). Among those treated in the OR setting, 38 patients (71.7%) were hospitalized, with a mean hospitalization duration of 1.9 days, while 15 patients (28.3%) who had the procedure were discharged several hours following the procedure.
Complete successful transvaginal myomectomy was accomplished in a significantly higher proportion of patients treated in the OR setting (98.1% versus 82.6%; p = 0.01). Four patients managed in the in-office setting underwent subsequent nonemergent successful transvaginal myomectomy in the OR, whereas 1 patient treated the OR setting proceeded to an additional transvaginal surgery in the same hospitalization period due to difficulty in reaching the base of the myoma pedicle in the first attempt made in the OR. In both groups, there were no cases of excessive or massive bleeding.
No significant differences were found between groups in regard to the lesions' size, hemoglobin postoperative decline, or blood products' transfusion requirements. Patients treated in the office setting were more likely to have at a myoma pedicle <2 cm (90% versus 41.4%; p = 0.007). In addition, a higher number of patients treated in the OR were confirmed to have leiomyomas histologically (79.2% versus 34.8%; p < 0.001; Table 1).
Among patients treated in the office setting, abdominal pain at admission was the only significant factor associated with removal failure, while neither the pedicle or lesion size correlated with a successful outcome (Table 2).
Factors Related to Successful Outcome of In-Office Transvaginal Myomectomy
Bolding denotes significant finding.
Histologic examinations revealed 25 cases (32.9%) of epithelial-origin lesions (18 were endometrial polyps and 7 were adenomyomas) and 50 cases (65.8%) of benign leiomyomas, with the remaining patient (1.3%) diagnosed with a carcinosarcoma.
During the follow-up period, an additional transvaginal myomectomy procedure was required in 2 patients (2.7%) and hysteroscopic myomectomy was required in 5 patients (6.6%), at a range of 3 months to 4 years following the first procedure due to persistent abnormal vaginal bleeding. Total abdominal hysterectomy was necessary in 1 patient (1.3%), at 3 years of follow-up due to symptomatic (abnormal vaginal bleeding and anemia) uterine fibroids after failure of conservative treatment.
Discussion
The current study, looked at treatment of clinically diagnosed prolapsed myomas in an in-office versus an OR setting. A higher success rate was found among patients treated in the OR. Nevertheless, successful removal was achieved in most patients treated in an office-based setting, particularly in the absence of abdominal pain at presentation.
The utilization of an in-office transvaginal approach for treating prolapsed pedunculated submucosal myomas has been scarcely reported. 9 In the current cohort, one-third of the patients underwent an in-office procedure with an overall success rate of 82.6%. While this rate was lower than that obtained in the OR setting, utilization of transvaginal myomectomy in the office was safe and performed easily, which obviated the need for general anesthesia and hospitalization. As suggested in the study's protocol, appropriate selection of eligible patients for this therapeutic approach is of paramount importance. While patients' hemodynamic stability, pain tolerance, and pedicle allowing for twisting off were eligibility criteria for an in-office procedure, myoma size was not a restrictive factor. Coupled with the current study findings, these criteria may serve for prospective studies to delineate the subset of patients most suitable for this clinical approach better.
The diagnosis of prolapsed myoma is clinically presumptive once the lesion has protruded through the cervical canal. However, as previously reported endometrial polyps might sometimes be difficult to distinguish from leiomyomas, as their macroscopic appearance as well as their clinical symptoms (e.g., irregular vaginal bleeding) often overlap. 6 Previous studies demonstrated final diagnoses of endometrial polyps in 5.7%–2.7% of cases presenting with prolapsed myomas6,10,11; accordingly, in the current study, final histologic examination revealed that 33.3% of cases were of endothelial origin (endometrial polyps and adenomyomas). This finding highlights the complex differentiation based on clinical presentation between these entities further.
The first limitation of this study is that its retrospective design raises the possibility of biases inherent to such investigations. Second, the relatively small sample size and the conducting of the study in a single institution could limit the generalizability of the results to different populations. Third, the decision regarding the treatment approach was not randomized but rather based on physician discretion, which could have led to a potential selection bias. Fourth, the study might have lacked sufficient statistical power to detect small—but clinically relevant—differences in infrequent outcomes.
Nevertheless, despite these potential caveats, as this was the first study to compare the utilization of an in-office versus an OR setting for treating protruding myomas, the current authors believe this study adds valuable information to the current literature and lays the groundwork for further investigations.
Conclusions
In this observational study, utilization of an in-office procedure for transvaginal removal of prolapsed pedunculated submucosal myomas, appeared to be safe with an overall favorable success rate. As this approach obviates the need for the need for general anesthesia and patient hospitalization, it is a plausible option, and might prove to be cost-effective. A lack of abdominal pain at presentation and the presence of a thin myoma pedicle were associated with successful outcomes of in-office procedures. However, as higher success rates occurred among patients managed in the OR, this should remain as the mainstay of treatment. As only two-thirds of patients were confirmed to have leiomyomas histologically, this emphasizes further the limited clinical diagnostic ability with respect to this condition. Further prospective studies are warranted to confirm these current findings and to delineate patients who are most suitable for in-office transvaginal myomectomy procedures better.
Footnotes
Acknowledgment
The authors thank Samuel Lurie, MD, for his comments on the manuscript for this article.
Author Disclosure Statement
No financial conflicts exist.