Comparative study between tactile electrosurgical ablation guided by rectal ultrasound and versapoint hysteroscopic ablation in cases of perimenopausal uterine bleeding

Perimenopause (often referred to as the menopausal transition) is the time period during which women go from premenopause (the reproductive years) into menopause []. The median length of perimenopause has been estimated to be anywhere between 4 [] and 11 years [], following the last cycle. Women are most likely to exhibit signs of perimenopause sometime in their 40s, although some women exhibit signs as early as their 30s or as late as their 50s []. There are epidemiological surveys which suggest that approximately as many as 10% of women in their early 30s could be approaching their perimenopause transition []. The causes of abnormal uterine bleeding (AUB) in non-gravid women of reproductive age are standardized in the International Federation of Gynecology and Obstetrics (FIGO) classification system (PALM-COEIN) []. PALM group includes five entities with structural etiologies of AUB that can be diagnosed with imaging techniques and/or histopathology (polyp, adenomyosis, leiomyoma, malignancy, and hyperplasia). COEIN group includes non-structural entities that are not diagnosed by imaging or histopathology: coagulopathy, ovulatory dysfunction, endometrial, iatrogenic, and not yet classified []. According to FIGO classification, women with no structural cause for AUB should actually be differentiated into one or a combination of the following three etiologies: coagulopathy (AUB-C), disorder of ovulation (AUB-O), or primary endometrial disorder (AUB-E) []. In a study of endometrial pathology in AUB, it has been found that the commonest pathology causing AUB is disordered proliferative pattern (20.5%); other causes include benign endometrial polyp (11.2%), endometrial hyperplasia (6.1%), carcinoma (4.4%), and chronic endometritis (4.2%) []. Up to 14% of women experience irregular or excessively heavy menstrual bleeding (HMB) []. Clinically, the gynecologists categorized the patient's bleeding pattern, before using the FIGO classification, into one of the four types: irregular bleeding, heavy but regular bleeding (menorrhagia), severe acute bleeding, and abnormal bleeding []. Menorrhagia is HMB and is classically defined as a loss of more than 80 ml/cycle []. Menorrhagia affects more than or equal to 9% of all women, increasing to 20% during the perimenopause []. HMB is an important cause for anemia in perimenopausal women; generally, HMB is a symptom of ovulatory disorders, primary endometrial disorders, fibroid, adenomyosis, and endometriosis or genital malignancies []. The anovulatory bleeding, which is more common near menarche and the perimenopause, is often irregular, heavy, and prolonged; it is more likely to be associated with endometrial hyperplasia and cancer []. Hysteroscopy is a highly specific, accurate, safe, and clinically useful tool for detecting intrauterine abnormalities and to direct the treatment toward the specific pathology []. It allows direct visualization of the uterine cavity and allows for directed biopsy at the time of procedure []. To achieve optimal visualization, diagnostic hysteroscopy should be performed in the follicular phase of the cycle and if the ultrasound examination is inconclusive or suggests intrauterine pathology [] Tactile electrosurgical ablation is another treatment modality. It is conducted by a specially designed insulated curved probe with a ball-like end 5 mm in diameter and a total exposed (active end) surface area of 43.6 mm []. This was named tactile electrosurgical ablation probe (TEA probe). Endometrial ablation has been performed with heat, cold, light, microwaves, chemicals, and radio frequency as sources of energy [], These methods are substantially distinct in the ease of use, learning curves, costs, efficacy, and safety. Indeed, life-threatening complications have been reported []. The main cause for conducting this this study is the limitation of resources used in hysteroscopic ablation as it expensive and not available all the time. These methods have the potential to treat challenging cases of endometrial ablation using a specially designed monopolar electrosurgical coagulation probe able to perform electrosurgical ablation without hysteroscopy. In a series of previous studies, the safety and the feasibility of TEA were investigated using an in vitro model of hysterectomy specimens []. Moreover, a pilot clinical study was conducted under laparoscopic monitoring []. The previous results showed complete coagulation of the endometrium along with 2–4 mm of the adjacent myometrium. No full-thickness damage was observed, with the maximum depth involving only 16% of myometrial thickness []. Laparoscopic monitoring was performed in the initial clinical series to confirm that full-thickness damage did not occur []. The aim was to evaluate the efficacy of TEA of endometrium under rectal ultrasound guidance versus modified tactile versapoint hysteroscopic ablation in the management of perimenopausal AUB. Patients and methods This study was conducted in the Department of Obstetrics and Gynecology of Al-Azhar University Hospital (Assuit), Egypt, on 50 perimenopasaul patients with AUB during the period from 1-10-2018 to 1-10-2019. Inclusion criteria Patients with dysfunctional uterine bleeding, aged between 35 and 45 years, unsuccessful medical treatment, and those who completed their families. Exclusion criteria Age less than 35 years or more than 45 years, coexisting gynecological pathology, endometrial hyperplasia with atypia and cancer, uterine size more than 12 weeks, women with previous scar such as cesarean section scar or myomectomy, and general causes for bleeding were the exclusion criteria. Complete history taking, including personal history, history of present illness, past history, menstrual history, obstetric history, medical history, and family history, was taken to fulfil inclusion criteria. At the time of registration, the baseline information was taken, especially with respect to age, parity, and general cause of bleeding. Investigations The following investigations were done: serum Na, coagulation profile, complete blood count, liver function tests (e.g. serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase, and bilirubin), random blood sugar, kidney function tests (e.g. serum creatinine and blood urea nitrogen), and urine analysis. Ultrasound Pelvic ultrasound was done for all cases. Patients were divided into 2 groups according to the endometrial ablation method: Group 1 (25 participants): ablation was done using tactile ablation guided by rectal ultrasound. Group 2 (25 participants): hysteroscopic ablation was done using versapoint hysteroscope. Follow-up of both group after ablation for 6-month duration was done. The following factors were assessed for both groups: Pre- and postoperative endometrial thickness. Complications during or after surgery. The cost in both groups. Outcomes (normal menses and lifestyle). Recurrence if occurs after 6 months. No. of patients who need hysterectomy after 6 months. Methodology In tactile ablation, operative time ranged from 10 to 15 min, depending on the size of the uterine cavity and proposed end points. The technique of TEA is largely similar to the dilatation and curettage procedure. Hence, the procedure requires to be aware of electrosurgical principles. We had satisfactory experience in ultrasonic monitoring, high-resolution ultrasonic machine used, and performing dilatation and curettage. Even if it seems that TEA is a blind technique, it is not underprivileged of direct external visual monitoring by ultrasonography. In addition, we performed TEA under the great tactile sense of the experience of our gynecologists. In hysteroscopy (versapoint) patients, they were also put under lithotomy position, and then complete sterilization was done. Hysteroscopy was used to enter intra-uterine cavity and then ablation was done by versapoint, under the effect of distension media (glycine 105%).

This study was conducted on 50 women with perimenopausal uterine bleeding, with 25 participants in each group: In group 1, no cases dropped out and failed to be followed up for 6 month and no cases were excluded from the study. The effectiveness of management (recurrence of Hge) was about 92%. In group 2, no cases dropped out and failed to be followed up for 6 months, and no cases were excluded from the study. The effective of management (recurrent of Hge) was about 76%. [Table 1]a and b shows the sociodemographic study between both the groups. Age in both groups ranged from 38 to 45 years, with mean±SD of 41.64±2.271 years in group 1 and mean±SD of 41.72±2.35 in group 2, with P value 0.903. Parity also showed no statistically significant difference between both groups. [Table 2] shows the intraoperative complications in the two groups, where regarding thermal ablation of vagina and genitalia, there were two cases in group 1 but no cases in group 2, with P value 0.245; regarding cervical injury, there were 2 cases in group 1 and one case in group 2, with P value 0.500; regarding perforation of uterus, there were two cases in group 1 and one case in group 2, with P value 0.500; regarding specific complication of endometrial ablation by versapoint hysteroscopic ablation, which occurred in group 2 only, by distension media, four cases had complications such as hyponatremia (decrease in serum sodium of 10 mmol/l); and regarding postoperative complications such as hematometra, one case only had hematometra in group 1, with P value 0.500. [Table 3] shows the cost in $, which ranged in group 1 from $14 to 20 and from $40 to 50 in group 2, with mean±SD in group 1 of $17.08±1.8 and in group 2 of $44.1±2.98, with P value less than 0.001**. Surgical time (min) ranged in group 1 from 10to 15 min and from 20 to 30 min in group 2, with mean±SD of 12.04±1.8 min in group 1 and mean±SD of 24.9±3.1 min in group 2, with P value less than 0.001**. [Table 4] shows the outcome after 6 months. There were two cases in group 1 who came with recurrent Hge and six cases in group 2, with P value 0.123. [Table 4] shows the change in menstrual pattern. Overall, two cases developed amenorrhea, six cases developed hypomenorrhea, and five cases developed oligomenorrhea in group 1, and in group 2, one case developed amenorrhea, two cases developed hypomenorrhea, and 2 cases developed oligomenorrhea, with P. value 0.132. [Table 5] shows the number of patients who needed hysterectomy after 6 months of operation. In group 1, no patient needed hysterectomy, and one case only needed to hysterectomy in group 2, with P value 0.312. [Table 6] shows the endometrial thickness. It decreased after ablation (mm) in group 1, ranging from 4 to 8 mm, and in group 2, ranging from 2 to 6 mm, with mean±SD of 6.12±1.09 in group 1 and mean±SD of 3.88±0.93 in group 2, with P value less than 0.001**.

Prevention of uterine bleeding to affect the general condition of perimenopausal women is the primary aim of this study. Perimenopause (often referred to as the menopausal transition) is the time period during which women go from premenopause (the reproductive years) into menopause []. Uterine ablation is effective in management of perimenopausal bleeding. EA improves treatment access for those women who have AUB and provides an alternative to major procedures such as hysterectomy []. Ablation is effective by tactile by about 85% These methods are substantially distinct in the ease of use, learning curves, costs, efficacy, and safety. Indeed, life-threatening complications have been reported []. These methods have the potential to treat challenging cases of endometrial ablation using a specially designed monopolar electrosurgical coagulation probe able to perform electrosurgical ablation without hysteroscopy []. Ablation is effective by hysteroscopy by about 70%. EA is now more prevalent than vaginal hysterectomy in Quebec. However, the effect of EA on hysterectomy rates remains uncertain. American statistics from six states show EA being used as an ‘additive medical technology rather than a substitute’ for hysterectomy []. Thus, the current study was performed to assess the efficiency of tactile ablation and hysteroscopic ablation in the management of irregular uterine bleeding in perimenopausal women. In the study of El Saman, et al. [], the study group was 19 women with irregular uterine bleeding, managed with tactile ablation, age ranged from 40 to 47 years, and time of operation ranging from 6 to 10 min. In our study, time of operation ranged in tactile ablation from 10 to 15 min and in versapoint ablation from 20 to 29 min, with highly statistically significant difference between the two groups. In our study, after 6 months of operative time, 3 cases developed amenorrhea (one in versa point group and two in tactile ablation group), with no statistically significant difference between the two groups. In the study of El Saman, et al. [], 9 cases developed amenorrhea from 6 to 24 months. However, in our study, after 1 year, only one patient need to do hysterectomy in group of versapoint, but no patient needed hysterectomy in the tactile group, with no statistically significant difference. In the study of El Saman et al. [], after 1 year, only one patient needed to do hysterectomy for recurrence of HMB. In the study of Sayed et al. [], 50 patients had irregular uterine bleeding, where 41 patients underwent hysteroscopic ablation, 8 underwent tactile ablation as hysteroscopic ablation could not be done because of severe bleeding or light source trouble, and 1 case underwent immediate hysterectomy owing to perforated uterus. In the study of Sayed et al. [], age of the patients ranged from 40 to 50 years, with mean±SD of 44±3.28 years, but in our study, age ranged 38–45 years, with mean±SD of 41.72±2.35 in the group of versapoint and mean±SD of 41.64±2.27 years in the group of tactile ablation. In the study of Sayed et al. [], mean±SD endometrial thickness (mm) was 4.4±0.99, but in our study, mean±SD endometrial thickness was 3.88±0.93 in the group of versapoint and mean±SD of 6.12±1.09 in the group of tactile ablation. In the study of Sayed et al. [], complications included perforated uterus in two cases, but in our study, three cases has perforated uterus, with one case in versapoint ablation and two cases in tactile group. In the study of Sayed et al. [], one case only needed hysterectomy during operation, but in our study, no case needed hysterectomy during the operation, but one case in group of versa point needed hysterectomy after operation as the second management. In the study of Sayed et al. [], 14 cases developed light menstrual bleeding (hypo or oligomenorrhea) in 41 cases managed by hysteroscopic ablation, and three cases in eight cases managed by tactile ablation 12 months after operative, but in our study, after 6 months, 11 cases developed light menstrual bleeding in group of tactile and four cases developed light menstrual bleeding in group of versa point. In the study of Sayed et al. [], after 12 months of operation, five cases needed hysterectomy, comprising four in the group managed by hysteroscopic ablation (41) and one case in the group managed by tactile ablation, but in our study, after 6 months, one case needed hysterectomy in the group of versapoint.

and recommendation

The quality of life depends upon multiple factors; however, one of the most important factors is genital tract health, as uterine bleeding is more common in perimenopausal women. Based on the results, we conclude the following: rapid treatment of uterine bleeding to avoid general health affection. tactile ablation shows less complications, has less cost, was more effective, but was less accurate, and it could not find any pathological lesion. hysteroscopic ablation has more complications, has more cost, is less effective, needs more time, but is more accurate and can find pathological lesion. Recommendation We recommended the use of tactile ablation in irregular uterine bleeding in perimenopasaul women as a rapid treatment, with less complications and less cost. Moreover, we recommended further studies as needed to assess the possibility of replacement of hysterectomy by tactile ablation in nonpathological perimenopausal irregular uterine bleeding, and ensure the efficacy of ablation of endometrium tissue. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

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