Failed diagnostic hysteroscopy: Analysis of 62 cases

Journal Pre-proof Failed diagnostic hysteroscopy: analysis of 62 cases Fortunato Genovese, Gisella D’Urso, Federica Di Guardo, Giulio Insalaco, L. Ciotta, A. Carbonaro, V. Leanza, Marco Palumbo

PII:

S0301-2115(19)30487-7

DOI:

https://doi.org/10.1016/j.ejogrb.2019.10.031

Reference:

EURO 11034

To appear in: Biology

European Journal of Obstetrics & Gynecology and Reproductive

Received Date:

21 June 2019

Revised Date:

30 September 2019

Accepted Date:

17 October 2019

Please cite this article as: Genovese F, D’Urso G, Di Guardo F, Insalaco G, Ciotta L, Carbonaro A, Leanza V, Palumbo M, Failed diagnostic hysteroscopy: analysis of 62 cases, European Journal of Obstetrics and amp; Gynecology and Reproductive Biology (2019), doi: https://doi.org/10.1016/j.ejogrb.2019.10.031

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier.

Failed diagnostic hysteroscopy: analysis of 62 cases Fortunato Genovese1, Gisella D’Urso1, Federica Di Guardo1, Giulio Insalaco1, L.Ciotta1, A.Carbonaro1, V.Leanza1, Marco Palumbo1 Department of Medical Surgical Specialties, University of Catania, Via Tindaro 2, 95124 Catania, Italy.


Correspondig Author:

Federica Di Guardo

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Department of Medical Surgical Specialties, University of Catania, Italy

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1

Gynecology and Obstetrics Section

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Tel + 39 349 3696016; [email protected]

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Via S.Sofia 78, 95100-Catania, Italy

Abstract

OBJECTIVE: the aim of this study is to improve the office hysteroscopy success rate identifying some of the factors associated to an unsuccessful procedure and to stress the importance of adeguate follow up of

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patients after

office hysteroscopy failure by enlightening the underlying uterine pathology missed at the

first attempt. STUDY DESIGN: retrospective observational study. The Authors review the medical records related to 516 office hysteroscopies performed from January 2016 and November 2018, extrapolating the charts of all failed hysteroscopies occurred during this period. After a failed procedure all patients are offered a repeat hysteroscopy under regional anesthesia

in order to identify and treat the underlying uterine pathology,

those, who decline a repeat procedure, receive an appropriate follow up. Each case of failure is correlated risk factors, patient

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with patient clinical characteristics, indications to hysteroscopy, the presence of compliance regarding a repeat hysteroscopy, pathology result and patient follow up . RESULTS:

The present study shows an office hysteroscopy failure rate of about 12 % , 62 failed

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hysteroscopy out of 516 procedures performed during a three year-period. Severe pain due to cervical stenosis, often secondary to previous surgery, postmenopausal status or marked uterine ventrifixation or represent the main reason for not being able to complete the procedure in an office setting.

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retroflexion,

The uterine cavity was subsequently examined in only 26 (42%) out of 62 patients, mostly through

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repeat hysteroscopy under regional anesthesia (24 cases) or through vaginal hysterectomy for associated benign gynaecological pathology (2 cases). A significative endometrial pathology (endometrioid carcinoma)

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was ascertained in 2 (7,7%) of them. Moreover the endometrial cavity remains so far unexplored in 36

(58%) out of 62 patients, because

declines a repeat hysteroscopy under

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anesthesia.

the majority of them

DISCUSSION AND CONCLUSION: the Authors , as a result of the present study, suggest that office

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hysteroscopy should be sussessful at the first attempt, because the majority of patients (58%), in case of a failed procedure, do not undergo a repeat hysteroscopy in a reasonable time and important diagnosis, such as that of endometrial cancer, may be missed or delayed. In order to increase the procedure success rate, prior to the scheduled hysteroscopy they recommend to counsel all patients, identifying those who may benefit from pharmacological cervical softening, local anesthetic injection or the use of small

caliber

hysteroscopes. 2

Key words: office hysteroscopy, anaesthesia, cervical stenosis, patient discomfort.

Introduction

Hysteroscopy is an endoscopic surgical procedure, which allows a direct visualization of the entire

2].

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uterine cavity. Today it is considered the gold standard for evaluation of intrauterine pathology [1, In the last decades the concept of diagnostic hysteroscopy has evolved toward office

hysteroscopy, which gives the possibility to see and treat many of the lesions observed, such as

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polyps or small fibroid [3]. Traditionally hysteroscopy was performed as a day care procedure and patients received regional anesthesia [4]. Nowadays, thanks to the improvement in materials and

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technologies, with increasingly smaller instrument diameters [5], the use of saline solution for the

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distention of the uterine cavity [6], and the ameliorating operator experience, the office hysteroscopy (OH) without anesthesia has progressively replaced operative hysteroscopy under

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regional or general anesthesia performed in the operating room [7,8]. However, it should not be forgotten that, even today, there is a considerable number of diagnostic hysteroscopy that cannot be

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carried out without anesthesia, mostly due to patient discomfort often secondary to anatomical impediments. Notwithstanding the operator’s adeguate technical skills, experience and

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instrumentation, in certain cases it is not possible, not only, to carry out biopsy or other office hysteroscopic operations, but

a guided endometrial

even, to visualize the entire uterine cavity and

make a diagnosis; under these circumstances it becomes absolutely necessary to discuss with the patient all the next available options. With this in mind the Authors direct their attention to what happens to patients with failed office hysteroscopy, trying to understand how many of them, subsequently, manage to complete their 3

diagnostic work up, what means are employed to reach the diagnosis , how important it is, and above all what should be done in order to avoid a failed hysteroscopy which, in other words, represents a missed diagnosis.

Materials and methods At the Institute of Obstetrics and Gynaecologic Pathology, of the Policlinico-Vittorio Emanuele January 2016 to November 2018 a total of 516

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University Hospital, Catania, Italy, from

hysteroscopies, have been performed in an ambulatory setting by an expert operator. A detailed explanation of the procedure is given to each patient, who is invited to sign an informed consent.

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Women with acute infections, active bleeding, viable pregnancy or unstable medical conditions (i.e., uncontrolled arterial hypertension, diabetes, neurologic disorders and cardiac disease) are

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excluded. In premenopausal women, the procedures are performed during the early proliferative

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phase of the menstrual cycle. All the hysteroscopies are performed in an office setting, a rigid hysteroscope, with a minimum diameter of 5 mm, equipped with a telescope of 2.9 mm and a 30° degree angle (Karl Storz-Bettocchi hysteroscope),

using the vaginoscopic approach [10],

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without tenaculum and speculum, is introduced through the vagina and the endocervical canal into the uterine cavity employing, as a distention medium, normal saline solution. In the presence of

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known risk factors, the examination has not been deferred or postponed in order to adopt measures

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to reduce the risk of failure, such as topical estrogen administration in postmenopausal women weeks before the examination, administration of misoprostol hours before the procedure, or anxiolytics in cases of patient’s particular apprehension towards the exam. Neither analgesia, nor local anesthesia are administered to the patient. A diagnostic hysteroscopy is considered complete when a sistematic examination of the uterine cavity is performed, inclusive of cervical canal, uterine fundus and tubal ostia. When the procedure cannot be performed, in primis the patients are offered a repeat hysteroscopy, either in office or in the operating room under anesthesia, in 4

secundis clinical and ultrasound follow up is proposed to patients who decline a repeat hysteroscopy with adeguate counseling. The Authors reviewed retrospectively the charts of

all the 516

hysteroscopy, peaking up only those related to failed office diagnostic procedures, which represent the exclusive object of this retrospective study. Data are collected from the chart of each patient and whenever possible further informations are obtained directly from each patient by telephone call. Each failed case is correlated with patient age, date of last menstrual period, menopausal status (years from menopause), parity, number of previous caesarean section and or normal spontaneous

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vaginal delivery, previous abdominal or gynaecological surgery, pelvic ultrasound findings, included marked uterine antiflexion or retroflexion, coexisting bleeding, and

indications to

hysteroscopy, further correlation is made between failed hysteroscopy and missed uterine pathology

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if recognized and or clinical follow up. Depending on the patient's choice, the Authors divided the patients with failed hysteroscopy in 5 groups; groupA: patients who accept to undergo a repeat

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hysteroscopy under loco-regional anesthesia; group B: patients

who choose clinical and

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ultrasound follow up; group C: patients who choose to undergo total hysterectomy under general anesthesia, for associated benign gynaecologic pathology; group D: patients lost to follow up;

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group E: patients still waiting for repeat hysteroscopy. Limitations of the present study are the retrospective nature of the study and the impossibility in

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Results

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some cases to achieve complete informations on each patient.

The Authors found that hysteroscopy was successful in 454 cases (87,9 %) and failed in 62 out of 516 office hysteroscopies performed, with a total office hysteroscopy failure rate of about 12%, similar to that reported by the International Literature, variable from a maximum of 56% to a minimum of 0,5% [2, 10, 28, 31]. Failure is generally due to one or more of the following factors: anatomic impedements (cervical stenosis at different level), bleeding, patient’s anxiety and patient’s 5

pain. Authors, although unable to quantify how much each factor has individually contributed to an unsuccessful office hysteroscopy, retain that cervical stenosis, according to the current Literature, may be considered the predominant cause of office hysteroscopy failure. Concerning the clinical history of the 62 patients, complete data about them are reported in table 1. The mean age was 52,5 years (22-84 years),

43,5 % of them were premenopausal and 56,5 %

postmenopausal; almost 23 % of patients had one or more previous cesarean sections and another

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11 % had a previous uterine curettage for incomplete abortion or termination of pregnancy.

As illustrated in detail by table 2, the most common indications to office hysteroscopy was

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postmenopausal bleeding with endometrial thickness > 5 mm (38,7%), followed by the following ones in decreasing order of frequency: suspected endometrial polyps (33,9%), suspected submucous

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myoma (8,1%), postmenopausal bleeding without endometrial thickening ( 6,5%), abnormal uterine

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bleeding without endometrial thickening (4,8%), and infertility ( 4,8%), see also figure 1.

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Regarding risk factors associated with office hysteroscopy failure, often causing cervical stenosis or uterine ventrifixation, they are reported for each patient in table 3. Only 6 (patient 6,7,12,14,20 and

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26) patients out of the 62 studied did not have risk factors for OHF (office hysteroscopy failure), instead the remaining 56 patients presented one or more risk factors, as illustrated in figure 2.

A repeat hysteroscopy under regional anaesthesia, although offered to all the 62 patients, was accepted by only 24 of them, group A, who underwent the procedure successfully in the 6

operating room; while 2 patients, group C, requested

to be submitted to

vaginal

hysterectomy under general anesthesia, for associated gynaecologic pathology. Therefore, so far, on the basis of the available informations, the uterine cavity was finally examined in only 26 (42%) out of 62 patients. An underlying endocavitary pathology was identified in all these 26 cases, as summarized in table 4, including the 2 patients (patient 13 and 57) who, bypassing the repeat hysteroscopy, underwent vaginal hysterectomy for associated uterine prolapse. The most frequent identified pathology is represented by

endometrial

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polyp, found in 19 cases (73,1%), followed by submucous myoma, found in 4 cases (15,4%); endometrioid carcinoma was diagnosed in 2 cases (7,7%), patient 18 and patient 50, and endometrial hyperplasia without atypia was ascertained only in 1 case (3,8%), see

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also figure 3.

On the other hand, as showed in table 5, the uterine cavity remained so far unexplored in 36

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(58%) out of 62 patients, divided as follow: 25 women, group B, (40,3%) chose clinical and

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ultrasound follow up, among them 1 patient for failed repeat hysteroscopy even under anesthesia, due to an inviolable secondary atresia of the cervical canal. 7 patients, group D (11,3%), after declining repeat hysteroscopy, were lost to follow up, and 4, group E

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Discussion

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(6,5%), are still waiting for a repeat hysteroscopy under anesthesia, see also figure 4.

Author’s analysis demonstrates that almost 90% of patients (fig.2) with failed hysteroscopy have one

or more of the risk factors, indicated in table 3, such as postmenopausal status, previous

cesarean sections or other abdominal surgery, conditions that may cause, with different meccanisms, more or less severe cervical stenosis or abrupt kinking of the cervical canal. The Authors notice that, in case of failure, only a minority (42% ) of patients, accepts a repeat 7

procedure, while the majority of them (58%) remains without a definitive diagnosis. Significant endometrial pathology, such as endometrial cancer, found in 7,7% of group A and C patients , may be missed or more lately diagnosed in group B patients, equal to 40,3% of the total, although appropriate ultrasound and clinical follow up is given. Additionaly the number of important missed diagnosis could further increase, considering that group D patients, equal to 11,1% of the total, are lost to follow up. should be successful at the first

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In view of these data, the Authors recognize that office hysteroscopy

attempt, and suggest that clinicians should meet all patients prior to the office hysteroscopy, in order to identify those at risk of failure, as indicated in table 3, and those with procedure related anxiety and low pain tolerance. Preoperative counselling would allow clinicians to adopt

specific pharmacological or technical

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(hysteroscope size, ancillary instrument for internal or external uterine os divulsion) measures, as suggested

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by the Literature, to improve patient compliance in selected cases and consequently decrease the procedure failure rate. Non pharmacological intervention have also been suggested to improve the procedure success

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rate such as pressure, stretching, heat, electricity, music and hypnosis [32]. In case, for instance, of patients with previous caesarean section or abdominal surgery,

the topical use of

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cervical ripening agents may be advised; in fact several studies, conducted in the last 10 years, investigating the role of misoprostol, have shown that the local administration of this prostaglandin prior to the procedure

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makes easier the hysteroscope passage through the cervix, reducing the risk of complications, such as cervical tears, and uterine perforation. As reported by a recent study, misoprostol seems to be more effective

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in premenopausal nulliparous women compared to postmenopausal women in reducing the pain during the introduction of the hysteroscope, but not necessarily throughout the entire procedure [15]. However clear data about the dosage, time and route of administration (vaginal or oral) are not still clear and its use has been reported to produce side effects such as preoperative pelvic pain and vaginal bleeding in a considerable number of patients[18]. In case of postmenopausal women, not on hormonal replacement therapy and without a history of breast cancer, topical estrogen use

may be suggested to counteract the atrophyc changes of the genital tract 8

leading to a painful and difficult uterine access [14], Casadei, et al. reported a statistically significant increase rate of successful hysteroscope introduction, and lower pain, using 5 mcg of estradiol vaginally daily for 14 days, followed by 400 mcg of misoprostol 12 hours prior to the procedure, demonstrating that the association of both pharmacological treatments is effective in partially solving cervical stenosis in postmenopausal patients [16,17,19]. Regarding the use of local anaesthetic, it may be taken in consideration during diagnostic outpatient hysteroscopy: the simple instillation of local anaesthetic into the cervical canal seems not to be effective on

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pain reduction, decreasing maybe only the incidence of vasovagal reactions, although the injection of local anaesthetic into or around the cervix is associated with pain reduction, it is still unclear how really advantageous it is.

Routine administration of intracervical or paracervical local anaesthetic has been

advocated especially when larger diameter hysteroscopes are being employed (outer diameter > 5mm) and or

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when the need for cervical dilatation is anticipated [23,24,25].

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As far as the hysteroscopes size is concerned, miniature hysteroscopes (outer diameter < 5 mm) have been reported to be effective on reducing the discomfort experienced by the woman, when used for outpatient

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hysteroscopy [14,28,29].

Although the office hysteroscopy is a minimally invasive procedure, a state of anxiety, from low to

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severe, is correlated with this procedure, therefore the use of pharmacological interventions such as administrations of anxiolytics and sedatives prior to the procedure has been advocated [20,21], preoperative counselling and patient education that are capable by themselves, to reduce

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preoperative anxiety [22].

Conclusions

Office hysteroscopy has gained worldwide acceptance and today is used as gold standard for the investigation and treatment of several pathologies involving the uterine cavity. However, although the minimally invasive nature of the procedure, severe pain and or low pain tolerance may represent an invalicable obstacle for a limited number cases, with the necessity to recur to a repeat 9

hysteroscopy under anaesthesia. Therefore various expedients, pharmacological and not, have been proposed in order to overcome cervical stenosis, patient anxiety and low pain tolerance at the first attempt, avoiding the problems related to the management of a failed procedure, but results from Literature are still controversial. To the best of Author’s knowledge, although office hysteroscopy has been demonstrated to be safe, reliable and mostly well tolerated by patients [30], the success of the procedure is not just dependent on the adoption of recent technological instrumentation such as miniaturization of

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equipment, but it is also influenced by the favourable anatomical characteristics of the uterus itself, by the individual pain sensibility as well as by the emotive conditions of the patient. A detailed collection of patient history, aimed to identify those cases at risk of failure, may help the clinicians

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to personalize the approach in view of an optimal hysteroscopic performance.

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Conflict of Interest: This work was not supported by any grant or other form of funding. The Authors declare no conflict of interest in relation to this article. The Authors alone are

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responsible for the content and writing of the paper.

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15. Tasma, M. L., et al. "Misoprostol for cervical priming prior to hysteroscopy in

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postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial." BJOG: An International Journal of Obstetrics & Gynaecology 125.1 (2018): 81-89.

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16. Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized,

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17. Costa AR, Pinto-Neto AM, Amorim M, Paiva LH, Scavuzzi A, Schettini J. Use of misoprostol prior to hysteroscopy in postmenopausal women: a randomized, placebo controlled clinical trial. Journal of Minimally Invasive Gynecology 2008; 15: 67–73.)

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29. Rullo S, Sorrenti G, Marziali M, Ermini B, Sesti F, Piccione E. Office hysteroscopy: comparison of 2.7 and 4mm hystero- scopes for acceptability, feasibility and diagnostic accuracy. J Reprod Med 2005;50:45–8. 30. Bettocchi S, Bramante S, Bifulco G, Spinelli M, Ceci O, Fascilla FD, Di Spiezio Sardo A. Challenging the cervix: strategies to overcome the anatomic impediments to hysteroscopy: analysis of 31,052 office hysteroscopies. Fertil Steril. 2016 May;105(5):e16-e17. 31. Cincinelli E, Parisi C, Galatino P, Pinto V, Barba B, Schonauer S. Reability, feasibility, and

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Table 1. Clinical characteristics of 62 patients with OHF (Office Hysteroscopy Failure)

AGE < 30 years 30-50 years >50 years Total

2 (3%) 27 (44%) 33 (53%) 62 (100%)

Total

27 (44%) 25 (40%) 10 (16%) 62 (100%)

MENOPAUSE

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Premenopause <20 years from ≥20 years from

Table 2. Clinical characteristics of 62 patients with OHF (Office Hysteroscopy Failure)

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PARITY

14 (23%)

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Nulliparity

N (%)

26 (42%)

Previous vaginal delivery and one or more previous caesarean section

7 (11%)

No informations about pregnancy

8 (13%)

Previous caesarean section (one or more)

7 (11%)

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Previous vaginal delivery (one or more)

TOTAL

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CURETTAGE

62 (100%)

N (%)

No curettage

47 (76%)

One or more curettage

7 (11%)

No informations about curettage

8 (13%)

TOTAL

62 (100%) 15

Table 3. Risk factors associated with OH failure found in 62 patients.

A: markedly antiflexed uterus B: markedly retroflexed uterus

Patient

46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56.

Previous cesarean section <3 >3

A

Bleeding

<3 √ Bilateral salpingo-oophorectomy

B √ # # √ √ √

Appendectomy

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B B B

<3 <3

# B # Myomectomy Unilateral salpingo- oophorectomy

<3

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A B B

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#

√

<3 <3 <3

√ √ √ √

< 10

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# B A B

Bilateral salpingo-oophorectomy

Appendectomy Unilateral salpingo-oophorectomy

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B

Intestinal resection

Removal of ovarian cyst

B B B

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41. 42. 43. 44. 45.

Previous Abdominal surgery

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1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40.

Menopause (years from): <10 10-20 >20

B

√ <3

< 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10 < 10

√ <3 >3 <3

< 10

A B Appendectomy Appendectomy Right oophorectomy B

<3

< 10 < 10 < 10 < 10 10-20 10-20 < 10 10-20 >20 10-20 10-20

<3 >3

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57. 58. 59. 60. 61. 62.

>20 10-20 10-20 >20 >20 >20

Cholecystectomy

# patient with no risk factor identified Table 4. Pathology identified in 26 patients with OHF ( Office Hysteroscopy Failure) who undergo repeat hysteroscopy under regional anesthesia (24 cases) or vaginal hysterectomy under general anesthesia (2 cases)

Endometrial hyperplasia without atipia

Endometrioid endometrial Carcinoma

Endometrial polyp

Submucous myoma

√

8¥ 12 13 15 ¥ 18 20 22 23 26 32 34 36 37 38 ¥ 39 42 44 46 47 48 ¥ 49 ¥ 50 53 55 ¥ 57 60

√* √ √ √

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√

√

√ √ √

√

√

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√ √ √ √ √ √ √ √ √

√ √ √* √ 19 ( 73, 1%)

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√

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Patient

4 (15, 4 %)

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1 (3,8%) 2 (7,7%) ¥ Patients who underwent operative hysteroscopy in other institutes. * patients who underwent vaginal hysterectomy under general anesthesia

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Table 5. Follow up of 36/62 failed hysteroscopy patients who didn’t undergo a repeat procedure (except patient 29)

Patient 1 2 3 4 5 6 7 9 10 11 14

Clinical and ultrasound follow up chosen √ √

Lost to follow up

Waiting for repeat hysteroscopy under anesthesia

√ √ √ √ √ √ √ √ √

17

16 17 19 21 24 25 27 28 29# 30 31 33 35 40 41 43 45 51 52 54 56 58 59 61 62

√ √ √ √ √ √ √ √ √ √ √ V √ √ √ √ √ √

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√ √ √

√

√ √ √ 25 ( 40,3% )

7 ( 11,3% )

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# failed repeat hysteroscopy

4 ( 6,5% )

18

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Figure 1. Distribution of Indications to diagnostic office hysteroscopy in 62 patients with OHF

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Figure 2. Distribution of risk factors associated with OHF found in 62 patients

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-p

ro of

Figure 3. Distribution of pathologies identified in 26 patients with OHF who underwent repeated hysteroscopy under regional anesthesia (24 cases) or vaginal hysterectomy under general anesthesia (2 cases)

45.00%

re

Figure 4. Distrubution of follow in 36 patients with OHF.

40.3%

40.00%

lP

35.00% 30.00% 25.00%

na

20.00% 15.00%

11.3%

10.00% 0.00%

ur

5.00%

Lost to follow up

Waiting for repeat hysteroscopy under anesthesia

Jo

Clinical and ultrasound follow up chosen

6.5%

20