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Abstract
Hysteroscopic surgery is the actual gold standard treatment for several types of intrauterine
pathologies, including submucous myomas (SMs). To date, the availability of Hysteroscopic
Tissue Removal systems (HTRs) opened a new scenario. Based on these elements, the
aim of this article is to review the available evidence about HTRs for the management
of SMs. We included 8 papers (3 prospective studies and 5 retrospective studies).
A total of 283 women underwent intrauterine morcellation of SM: 208 were treated using
MyoSure and 75 using Truclear 8.0. Only 3 articles reported data about procedures
performed in outpatient/office setting. Only half of the included studies included
type 2 SMs. HTRs significantly reduced operative time compared to traditional resectoscopy
in some studies, whereas others did not find significant differences. Despite the
availability of few randomized controlled trials and the cost of the instrument, according
to our systematic review, the use of HTRs seems to be a feasible surgical option in
terms of operative time and complications. Nevertheless, the type of SM still remains
the biggest challenge: type 0 and 1 SMs are easier to manage with respect to type
2, reflecting what already is known for the “classic” hysteroscopic myomectomy.
The purpose of this randomized controlled study was to compare conventional resectoscopy and hysteroscopic morcellation among residents in training (Canadian Task Force classification I). Sixty women with an intrauterine polyp or myoma were randomized to either hysteroscopic removal by conventional resectoscopy or hysteroscopic morcellation performed by 6 residents in training for obstetrics and gynecology (10 procedures per resident). The mean operating time for resectosocpy and morcellation was 17.0 (95% confidence interval [95% CI] 14.1-17.9, standard deviation [SD] 8.4) and 10.6 (95% CI 7.3-14.0, SD 9.5) min, respectively (p = .008). Multiple linear regression analysis showed that operating time increased significantly, for both resectoscopy and morcellator, when volume of intrauterine disorder increased. The use of the hysteroscopic morcellator reduced operating time more than 8 min in comparison to conventional resectoscopy (p < .001) when correction for volume was applied. Subjective surgeon and trainer scores for convenience of technique on a visual analog scale were in favor of the morcellator. No learning curve was observed. In conclusion, the hysteroscopic morcellator for removal of intrauterine polyps and myomas offers a good alternative to conventional resectoscopy for residents in training.
Purpose and scope The aim of this guideline is to provide clinicians with up-to-date, evidence-based information regarding management of distension media in operative hysteroscopy, with particular reference to prevention and management of complications that may arise from fluid overload. Identification and assessment of evidence This guideline was developed using the methodology described by the RCOG for developing RCOG Green-top Guidelines (Clinical Governance Advice No.1: Development of RCOG Green-Top Guidelines (available on the RCOG website at http://www.rcog.org.uk/womens-health/clinical-guidance/development-rcog-green-top-guidelines-policies-andprocesses). The classification of evidence levels and grade of recommendations are given in Appendix 1. The Cochrane Library (CENTRAL), MEDLINE (through PubMed), EMBASE (through Embase.com) were searched for potentially eligible records. We searched the databases using a combination of MeSH (Medical subject Headings) and relevant index terms. We used MeSH or index terms for the following key word: “operative hysteroscopy”, “TCRE”, “TCRF”, “hysteroscopy” AND “glycine”, “resectoscope”, “hysteroscopy” AND “fluid overload”, “hysteroscopy” AND “distension media”, “hysteroscopy” AND “management”. The search was limited to humans and papers in the English language. Relevant guidelines were also searched using the same criteria in the National Guidelines Clearinghouse, the National Electronic Library for Health, the Organising Medical Networked Information (OMNI) and the Canadian Medical Association (CMA) Infobase. The literature search, study selection and data extraction were carried out by two authors (SU and DM) independently, and a third author (JC) made the final decision in case of disagreement. Three authors (SU, DM and JC) graded the level of evidence. Introduction Hysteroscopy enables visualisation of the uterine cavity and allows the diagnosis and surgical treatment of intrauterine pathology. To achieve this, the uterine cavity needs to be distended by a medium which could either be fluid or carbon dioxide [1]. Carbon dioxide is used for diagnostic hysteroscopy, as bleeding during operative procedures obscures visibility. For this reason, fluid media are used for operative procedures, as they allow continuous irrigation giving a clear picture and enable use of both mechanical and electrosurgical instruments. During operative hysteroscopy absorption of large volumes of distension solutions can occur leading to serious complications arising from significant fluid overload. Excessive fluid absorption is most likely with prolonged hysteroscopic procedures requiring continuous irrigation of fluid or where blood vessels within the myometrium are opened. Thus, particular care is required with resection of the endometrium (transcervical resection of the endometrium – TCRE) and hysteroscopic myomectomy – transcervical resection of fibroids – TCRF). Operative hysteroscopic procedures are usually carried out using resectoscopes which are larger diameter, continuous flow operating hysteroscopes. They incorporate a working element that moves an electrically activated wire loop. These devices were initially developed to use monopolar current, which require non-electrolyte distending media such as glycine and sorbitol. Such solutions are however hypotonic so that excessive absorption can cause a number of complications including hyponatremia, a variable degree of hypo-osmolality, and certain solution-specific problems that are described below. Isotonic electrolyte-containing solutions cannot be used with monopolar energy because this leads to activation of ions that disperse the electric current and reduce the power density. Hence the heat generated in tissues is insufficient to destroy or have a tissue effect [2]. Resectoscopes have now been developed to use bipolar electrical current with the advantage that they are compatible with electrolyte-containing distension solutions such as physiological normal saline and Ringer’s lactate. Use of these solutions reduces the risk of hyponatremia, but excessive absorption can, as with monopolar current, lead to expansion of the extracellular fluid volume with the potential to generate fluid overload, pulmonary oedema, hypertension and cardiac failure. Operative hysteroscopy can also be performed using small diameter, continuous flow hysteroscopes which incorporate a small, usually 5Fr or 7Fr, diameter working channel down which mechanical or electrosurgical instruments can be passed. Tissue removal systems refer to operative hysteroscopes that have been designed to simultaneously cut and aspirate tissue from within the uterine cavity. These systems usually incorporate their own fluid monitoring equipment but fluid overload can still occur. Smaller diameter operative hysteroscopes are less likely to cause fluid overload due to smaller diameter inflow channels and the generally less invasive nature of procedures that can be undertaken with such technology. However fluid overload may still occur and vigilance when using any operative hysteroscopic technology is mandatory. Fluid overload What is the definition of fluid overload? A fluid deficit of more than 1000 ml should be used as threshold to define fluid overload when using hypotonic solutions in healthy women of reproductive age. [C] A fluid deficit of 2500 ml should be used as threshold to define fluid overload when using isotonic solutions in healthy women of reproductive age. [GPP] Data evaluating fluid deficit during hysteroscopic surgery are lacking preventing a standard definition of fluid overload. A decrease in serum sodium of 10 mmol/L corresponds to an absorbed volume of approximately 1000 mL when using 1.5 % glycine [3] and it is for this reason that a fluid deficit of 1000 mL has traditionally been the threshold at which procedures should be curtailed in women of reproductive age when using hypotonic media. With the advent of bipolar electrosurgical systems using isotonic solutions, fluid deficits >1000 mL will be tolerated by healthy women but a safe, upper limit is not still well defined and will depend upon an individual’s size, age and medical fitness. In the absence of evidence to define an upper safe threshold for isotonic media the BSGE/ESGE Guideline Development Group recommends a limit of 2500 ml. This is in line with other national guidelines [4]. These thresholds apply to otherwise healthy fit women. However, in the elderly or those women with co-morbid conditions such as cardiovascular disease and renal impairment, lower thresholds should apply and it is suggested that upper fluid deficit levels of 750 ml for hypotonic solutions and 1500 ml for isotonic solutions [4]. What should be the incidence of fluid overload during hysteroscopic surgery? The incidence of fluid overload will vary according to case mix and type of hysteroscopic surgery. In general when using large diameter resectoscopes the incidence of fluid overloads should be less than 5 %. [D] The clinical course and outcome of all women with fluid overload should be audited. This should include unrecognised fluid overload in women presenting post-operatively as well as all women where fluid overload was identified during surgery. [GPP] The incidence of fluid overload during hysteroscopic surgery is generally low [5]. Several prospective and retrospective studies have looked at the incidence of excessive fluid absorption and electrolyte disturbances during operative hysteroscopy and most report rates under 5 % [6–12]. Given the absence of a uniform definition of fluid overload, women manifesting with signs or symptoms of fluid overload post-hysteroscopic surgery should be recorded and followed up in the same way as those symptomatic and asymptomatic women who reach the pre-defined threshold for fluid overload. Complications of distending media The complications of distension media during hysteroscopic surgery depend primarily on the type of medium used and the complexity of the operation. The main complications that occur are related to fluid absorption during the procedure leading to fluid overload with or without electrolyte imbalance. What factors pre-dispose to systemic fluid absorption? Surgeons should understand the factors that can lead to systemic fluid absorption. High intrauterine distension pressure, low mean arterial pressure, deep myometrial penetration, prolonged surgery and large uterine cavities increase the likelihood of systemic fluid absorption. [GPP] Absorption of distension media into the systemic circulation occurs by (i) retrograde passage of the fluid through the fallopian tubes, (ii) through the endometrium and (iii) via opened blood vessels and sinuses during resection of uterine tissue when the intrauterine pressure is greater than the pressure in the venous sinus or blood vessel. Factors influencing absorption of distension fluid include: Intrauterine pressure – the higher the pressure, the greater the degree of absorption into the body; systemic absorption of fluid increases considerably when intrauterine pressure exceeds mean arterial pressure [13]. In addition, intrauterine pressures > 75 mm Hg increases the volume of media passing back along the fallopian tubes and into the peritoneal cavity [14]. Mean arterial pressure – the lower the mean arterial pressure, the lower the intrauterine pressure required to cause passage of fluid into the systemic circulation. Caution is thus required in the elderly and those with cardiovascular co-morbidities [15]. Depth of myometrial penetration - when tissue damage extends into the deeper myometrium, instilled fluid can be rapidly absorbed through opened myometrial venous sinuses. The risk of fluid absorption is even greater during myomectomies where large blood vessels are breached facilitating the absorption of fluid under pressure. Duration of surgery – the longer the procedure the more time for fluid to accumulate within the body [16]. Size of uterine cavity – larger cavities provide a greater endometrial surface area for fluid absorption and procedures will generally be longer. However, despite requiring more instilled fluid, high intrauterine pressures to allow adequate visualisation are harder to achieve [2]. Thus, rapid systemic fluid absorption is greatest with prolonged hysteroscopic procedures using large diameter endoscopes with high rates of media inflow creating significantly elevated intrauterine pressure and where uterine trauma and vessel transection occur such as with hysteroscopic myomectomy especially FIGO type I/II fibroids [17] metroplasty and endometrial resection. What factors influence the severity and nature of complications arising from excessive systemic fluid absorption? Surgeons should understand the factors that influence the severity and nature of complications arising from excessive systemic fluid absorption. Severe complications are more likely with hypotonic (low osmolality) electrolyte free solutions, women of pre-menopausal status and those with cardiovascular or renal disease. [GPP] Factors impacting on the propensity to serious complications arising from fluid overload include: Osmolality of distension fluid - hypotonic electrolyte-free solutions like glycine, mannitol and sorbitol can cause hyponatraemic hypervolaemia. If unrecognised and left untreated, bradycardia and hypertension can develop, rapidly followed by pulmonary oedema, cardiovascular collapse and death [18]. Menopausal status - premenopausal patients have a higher risk of developing neurological complications due to the suppressive effects of oestrogen on the ATPase pump which regulates the flow of electrolytes through the blood brain barrier [19, 20]. Cardiovascular and renal disease – those women with known cardiovascular disease, renal impairment and the elderly are less likely to adapt to sudden significant increases in intravascular fluid such that complications from systemic fluid expansion and electrolyte imbalance are more likely at lower levels of fluid deficit [11]. What complications arise from excessive systemic absorption of fluid distension media? Surgeons should be aware of the potential complications when using different distension media during hysteroscopic surgery. These include morbidity and mortality arising from cardiovascular complications (pulmonary oedema and heart failure) and neurological complications (cerebral oedema, neurological impairment and seizures). [GPP] The degree of systemic fluid absorption indicated by the size of the recorded fluid deficit and the type of the distension media will influence the presenting symptoms, type and severity of complications. All types of fluid media can potentially cause complications where there is rapid systemic absorption, expansion of the systemic circulation leading to pulmonary oedema and heart failure. However, clinically significant fluid and electrolyte disturbances are more likely with hypotonic and electrolyte-free distension media [3] because they create an osmotic imbalance between extracellular and intracellular fluid. Conditions of hypo-osmolality and hyponatraemia cause water to move into brain cells inducing cerebral oedema, neurological impairment, seizures and even death [3]. Physiological isotonic solutions such as normal saline are less likely to cause such electrolyte disturbance [21]. How do complications from excessive systemic absorption of fluid distension media present and how should they be managed? Surgeons should be cognisant of cardiovascular and neurological symptoms associated with systemic absorption of fluid distension media complications to allow timely recognition and treatment. [D] Where excessive systemic absorption of fluid distension media is suspected, strict fluid balance monitoring should be commenced, a urinary catheter inserted and serum electrolytes measured. If the patient develops signs of cardiac failure or pulmonary oedema a cardiac echocardiogram and chest X-ray should be undertaken. [GPP] Asymptomatic hypervolemia with or without hyponatraemia should be managed by fluid restriction with or without diuretics. [GPP] The management of symptomatic hypervolemic hyponatraemia requires multidisciplinary involvement including anaesthetists, physicians and intensivists in a high dependency or intensive care unit. Initial treatment with 3 % hypertonic sodium chloride infusion is indicated to restore serum sodium concentrations to safe levels. [GPP] Fluid overload with hypotonic fluid media Glycine 1.5 % (200 mOsm/L) and sorbitol 3 % (165 mOsm/L) are the most common hypotonic electrolyte-free distending media used for operative hysteroscopy with monopolar electrosurgical energy. Moderate fluid overload causes hypervolaemia and consequent dilutional hyponatraemia. At that stage, despite the drop of sodium concentration, the osmolality of the blood is not greatly affected (normal osmolality, 280 mOsm/L). This asymptomatic hyponatraemia can be managed with fluid restriction and diuretics such as frusemide in the absence of a diuresis. Symptoms usually develop when serum sodium concentration drops below 125 mmol/L. The most frequent symptoms are headache, nausea, vomiting and weakness. If further fluid intravasation occurs, reduction of the blood osmolality creates an osmotic gradient that moves water into the interstitial and intracellular space, leading to brain oedema and increased intracranial pressure. The resultant cerebral oedema may present with signs of cerebral irritation such as agitation, apprehension, confusion, weakness, nausea, vomiting, visual disturbances, blindness and headache. If significant, it can lead to brain stem herniation, coma and death [22]. A further fall of sodium below 120 mmol/L may lead to confusion, lethargy, seizures, coma, arrhythmias, bradycardia and respiratory arrest. Thus, early recognition and treatment is essential to prevent cardiovascular complications and permanent neurological sequelae resulting from toxic hyponatraemia. A strict fluid balance must be commenced in theatre and should extend into the postoperative period. A urinary catheter should be inserted and the electrolytes, urea and creatinine measured. A loop diuretic like frusemide should be given intravenously and the urine output measured. If the patient develops signs of cardiac failure or pulmonary oedema a cardiac echocardiogram and chest X-ray should be undertaken with involvement of the physicians. The management of symptomatic hyponatraemia requires multidisciplinary involvement including anaesthetists, physicians and intensivists in a high dependency or intensive care unit (Table 1). Intravenous infusion of a slow 3 % hypertonic sodium chloride infusion (typically 1–2 mmol/L/h to prevent pontine myelinolysis) is indicated until serum sodium rises to 125 mmol/ [2, 18, 22, 23] correcting any cerebral oedema and reducing the risk of systemic complications. Acute hyponatraemia below 120 mm/l and/or acute symptomatic hyponatraemia should be treated with a 100 ml bolus of 3 % saline over 10 min and this can be repeated up to three times, followed by an infusion as described above. The recommended target increase of the serum sodium is 6 mmol/L over 24 h until 130 mmol/L is reached. Even a small increase in the sodium concentration can reduce the risk of cerebral oedema and its [24, 25]. The clinical condition and observations such as oxygen saturations, urine output and serum electrolytes including potassium and calcium should be closely monitored. Table 1 Management of suspected hypervolaemic hyponatraemia arising from fluid overload >1000 ml with hypotonic distension media Acute hypervolaemic hyponatraemiaa Management Asymptomatic hyponatraemia & [Na+] ≥120 mmol/L Fluid restriction (e.g., 1000 mL (20 % versus 4 %), a greater fall in serum sodium concentration (2.0 meq/L versus 0.5 meq/L and a greater rate of fall in sodium concentration ≥10 meq/L (8 % versus 0 %) than local anaesthesia with sedation. However, cases deemed suitable for local anaesthesia and hence eligible for randomisation are likely to have been less complex, short duration procedures limiting the generalisability of these findings. Another small RCT with 24 patients compared general with epidural anaesthesia during endometrial resection. There was significantly lower glycine deficit in the general anaesthesia group [64]. Suggested audit topics Proportion and type of hysteroscopic procedures exceeding recommended fluid deficits and exploration of clinical outcomes Prevalence of fluid distention media complications and compliance with guidance presented for subsequent management. Impact of innovations to reduce fluid overload on subsequent prevalence Recommendations for research Safe maximum fluid deficit thresholds during operative hysteroscopy for isotonic fluids Effectiveness of automated fluid delivery systems in reducing fluid distension media complications Effectiveness and safety, including fluid distention media complications, of new hysteroscopic tissue removal systems compared with conventional electrosurgery for operative hysteroscopic procedures such as myomectomy. The distension media related complications are relatively uncommon and RCTs to study the safety of surgical procedures would need large numbers of study entrants. Data on safety and complications may be more adequately collected prospectively from multiple centres within a reasonable amount of time. Online registries under the auspices of large international societies such as the ESGE may be useful tools to measure the incidence of complications before and following the introduction of new techniques, instruments and clinical practice guidelines. Executive summary of recommendations Good practice point - Recommended best practice based on the clinical experience of the guideline development group. Incidence of fluid overload A fluid deficit of more than 1000 ml should be used threshold to define fluid overload when using hypotonic solutions in healthy women of reproductive age. [C] In the absence of a consensus, a fluid deficit of 2500 ml should be used threshold to define fluid overload when using isotonic solutions in healthy women of reproductive age. [GPP] The incidence of fluid overload will vary according to case mix and type of hysteroscopic surgery. In general when using large diameter resectoscopes the incidence of fluid overloads should be less than 5 %. [D] The clinical course and outcome of all women with fluid overload should be audited. This should include unrecognised fluid overload in women presenting post-operatively as well as all women where fluid overload was identified during surgery. [GPP] Complications of distending media Surgeons should understand the factors that can lead to complication related to distension media. [GPP] Surgeons should understand the factors that influence the severity and nature of complications arising from excessive systemic fluid absorption. [GPP] Surgeons should be aware of the potential complications when using different distension media during hysteroscopic surgery. [GPP] Surgeons should be cognisant of symptoms associated with distension media complications to allow timely recognition. [D] Fluid absorption of over 1000 ml of hypotonic solution can cause clinical hyponatraemia. [D] Mild symptoms can develop even with absorption of over 500 ml of a hypotonic solution. [C] Larger volumes of isotonic solution need to be absorbed to cause symptomatic fluid overload but there are no data to define a safe threshold. [D] Isotonic medium is considered safer than hypotonic media as fluid absorption does not cause hyponatraemia. [A] Fluid deficit should still be closely monitored when using either hypotonic or isotonic distension media. [GPP] A maximum fluid deficit of 1000 ml should be set when using a hypotonic solution in a healthy woman and surgery immediately stopped on reaching this limit. [C] A maximum fluid deficit of 2500 ml should be set when using an isotonic solution in a health woman and surgery immediately stopped on reaching this limit. [GPP] Lower thresholds for fluid deficit should be considered in the elderly and women with cardiovascular, renal or other co-morbidities. Suggested upper limits are 750 ml for hypotonic solutions and 1500 ml for isotonic solutions although these limits may need to be reduced depending upon the clinical condition of the woman during surgery. [GPP] Most serious complications associated with fluid media are related to excessive absorption during surgery and rarely gas or air embolism during the procedure. [D] Choosing distension medium Isotonic, electrolyte-containing distension media such as normal saline should be used with mechanical instrumentation and bipolar electrosurgery because it is less likely to cause hyponatraemia where there is fluid overload. [D] Hypotonic, electrolyte-free distension media such as glycine and sorbitol should only be used with monopolar electrosurgical instruments. [D] Carbon dioxide gaseous media should not be used for operative hysteroscopy. [GPP] Strategies to reduce fluid absorption Preoperative administration of GnRH agonists should be considered in premenopausal women before hysteroscopic resection of fibroids. [B] Intracervical injection of dilute Vasopressin can be considered before dilatation of the cervix. [B] The intrauterine pressure needed for distension should be maintained as low as possible to allow adequate visualisation and kept below the mean arterial pressure. [B] Delivery of distension media Delivery of the distension medium can be safely and effectively achieved using simple gravity, pressure bags or automated delivery systems. [D] Automated pressure delivery systems facilitate the creation of a constant intrauterine pressure and accurate fluid deficit surveillance which is advantageous with prolonged cases such as endometrial resection or hysteroscopic myomectomy. [D] Monitoring fluid deficit Mechanisms should be in place to monitor fluid deficit during operative hysteroscopic surgery. [GPP] Closed systems should be used as they allow more accurate measurement of the fluid output. [GPP] Drapes that contain a fluid reservoir should be used as they allow measurement of the fluid output. [GPP] Automated fluid measurement systems are more accurate than manual measurement but they can still overestimate fluid deficit. Their use should be considered for prolonged complex hysteroscopic procedures where fluid absorption is anticipated. [D] Measurement of the fluid deficit should be done at a minimum of 10 min intervals during hysteroscopic surgery. [GPP] Anaesthesia and impact upon fluid overload and electrolyte imbalance Where feasible, the use of local anaesthesia with sedation should be considered for performing operative hysteroscopic procedures rather than general anaesthesia because fluid overload may be minimised. [B]
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