TBEA (Thermal Balloon Endometrial Ablation) использование при гиперплазии эндометрия

[dr_medvedev]

Human Reproduction, Vol. 14, No. 11, 2743-2747, November 1999
© 1999 European Society of Human Reproduction and Embryology

Thermal balloon ablation versus endometrial resection for the treatment of abnormal uterine bleeding
A. Gervaise1, H. Fernandez1,3, S. Capella-Allouc1, S. Taylor1, S.La Vieille2, J. Hamou1 and V. Gomel1

1 Department of Obstetrics and Gynecology, Antoine Beclere Hospital, 157, Rue de la Porte de Trivaux, 92140 Clamart and 2 CEMKA, 43, Bd du Maréchal Joffre, 92340 Bourg-La-Reine, France

This study compares the clinical efficacy and safety of a thermal uterine balloon system with hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. In all, 147 women were treated by two experienced gynaecological surgeons: one performed 73 thermal balloon ablations and the other 74 endometrial resections between November 1994 and April 1998. The inclusion criteria were similar in both groups. The operative time was reduced significantly with the uterine balloon technique. There were no intra-operative complications in either group and postoperative morbidities were minimal and not statistically different. Multivariate analysis noted two prognostic factors associated with failures: retroverted uterus with thermal balloon ablation and age under 43 years with endometrial resection. The overall success rate did not differ significantly between the two groups 83.0 ± 5% for balloon ablation and 76.3 ± 6% for endometrial resection. Uterine balloon ablation appears to be as efficacious as endometrial resection. The former is much easier to perform, making the technique readily reproducible, especially by those with limited expertise in hysteroscopic surgery, and thus more widely applicable and safer.

При мено- и метроррагиях выглядит многообещающе. Кто что скажет по поводу гиперпластических процессов эндометрия?

[dr_medvedev]

: Br J Obstet Gynaecol. 1998 May;105(5):517-23. Related Articles, Links

Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. International Collaborative Uterine Thermal Balloon Working Group.

Amso NN, Stabinsky SA, McFaul P, Blanc B, Pendley L, Neuwirth R.

Department of Obstetrics and Gynaecology at Queen Elizabeth Hospital, Gateshead, UK.

OBJECTIVE: To evaluate the safety and efficacy of thermal balloon therapy for menorrhagia. DESIGN: Prospective, observational study. SETTING: Fifteen centres in Canada and Europe. POPULATION: Two hundred and ninety-six eligible women for whom follow up data were available for three months or more. Eligible women included those for whom further fertility was not a concern, were not postmenopausal, suffered from intractable menorrhagia, had a normal uterine cavity, and who were fully informed regarding the investigational nature of uterine thermal balloon therapy. METHODS: Three hundred and twenty-one procedures of balloon endometrial ablation were performed using the same protocol between June 1994 and August 1996. Exclusion criteria included structural uterine abnormality or (pre) malignant lesions. Treatment entailed controlled heating of fluid in an intrauterine balloon. General anaesthesia was employed in the 61% of procedures while local anaesthesia with or without sedation was used in 39% of cases. ANALYSIS: Follow up data at 3 and/or 6, and/or 12 months were required for inclusion in the analysis. A paired t test, Wilcoxon signed-ranks test, and multiple and logistic regression analyses were used to evaluate the changes in bleeding and dysmenorrhoea patterns, and possible confounding variables, respectively. Success was defined as the subjective reduction of menses to eumenorrhoea or less. RESULTS: No intra-operative complications occurred, and post-operative morbidity was minimal. Success of the procedure was constant over the year (range 88%-91%). Treatment led to a significant decrease in the duration of menstrual flow and severity of pain (P < 0.0001). Increasing age, higher balloon pressure, smaller uterine cavity, and a lesser degree of pre-procedure menorrhagia were associated with significantly improved results. Pre-treatment with gonadotrophin releasing hormone agonists increased amenorrhoea and spotting rates (P = 0.03), but was only used in 5% of cases. CONCLUSION: Thermal balloon endometrial ablation appears to be safe, as well as effective in properly selected women with menorrhagia and is potentially an outpatient procedure.

Publication Types:
Multicenter Study

[dr_medvedev]

J Am Assoc Gynecol Laparosc. 2000 May;7(2):175-9. Related Articles, Links

Thermal balloon and rollerball ablation to treat menorrhagia: two-year results of a multicenter, prospective, randomized, clinical trial.

Grainger DA, Tjaden BL, Rowland C, Meyer WR.

Division of Reproductive Endocrinology, University of Kansas School of Medicine Wichita, 2903 East Central, Wichita, KS 67214, USA.

STUDY OBJECTIVE: To evaluate 2-year follow-up results in patients participating in a randomized, clinical trial comparing uterine balloon therapy with rollerball endometrial ablation. STUDY DESIGN: Prospective, randomized, clinical trial (Canadian Task Force classification I). SETTING: Fourteen university-affiliated and private practice sites. PATIENTS: Two hundred fifty-five women with menorrhagia. INTERVENTIONS: Patients were randomized to rollerball or uterine balloon endometrial ablation. MEASUREMENTS AND MAIN RESULTS: Patient satisfaction with both treatments was consistently high. Only 15 hysterectomies had been performed (6 for menorrhagia) at the end of 2 years, 11 in the rollerball group, 4 in the balloon therapy group. CONCLUSION: Endometrial ablation by both procedures was highly successful in avoiding hysterectomy and relieving symptoms of menorrhagia. Additional benefits were reduction in dysmenorrhea and premenstrual syndrome.

Publication Types:
Clinical Trial
Randomized Controlled Trial

J Am Assoc Gynecol Laparosc. 1999 Nov;6(4):435-9. Related Articles, Links

Thermal balloon endometrial ablation to treat menorrhagia in high-risk surgical candidates.

Aletebi FA, Vilos GA, Eskandar MA.

Department of Obstetrics and Gynecology, St. Joseph's Health Center, University of Western Ontario, London, Canada.

OBJECTIVE: To evaluate the safety and efficacy of thermal balloon therapy in a subset of women with menorrhagia considered to be high-risk surgical candidates for hysteroscopic endometrial ablation or hysterectomy. DESIGN: Prospective, observational study (Canadian Task Force classification II-2). SETTING: University-affiliated teaching hospital. PATIENTS: Women with menorrhagia, at high risk because of bleeding disorders (12), morbid obesity (6), heart-lung transplantation (2), cardiac pacemaker (2), postmenopausal bleeding (8), bowel disease with extensive adhesions and ileostomies (3), cervical stenosis (3), and other medical disorders (9). INTERVENTION: Treatment consisted of controlled heating to 87 degrees C of 5% dextrose in water within an intrauterine latex balloon pressurized to 170 mm Hg for 8 minutes. General anesthesia was used in 28 patients (60%) and local anesthesia with or without intravenous sedation in 18 (40%). MEASUREMENTS and MAIN RESULTS: No intraoperative complication occurred and postoperative morbidity was minimal. Follow-up of 43 women ranged between 6 and 30 months. Overall success of the procedure was 79% (34 patients), with 33% reporting amenorrhea, 19% hypomenorrhea, 28% eumenorrhea, and 21% menorrhagia. CONCLUSION: Thermal balloon endometrial ablation is safe and effective in treating menorrhagia when other therapies are contraindicated or difficult to perform.

JSLS. 2002 Oct-Dec;6(4):305-9.

Long-term results in the treatment of menorrhagia and hypermenorrhea with a thermal balloon endometrial ablation technique.

Mettler L.

Department of Obstetrics & Gynaecology, University of Kiel, Kiel, Germany. [Ссылки доступны только зарегистрированным пользователям ]

BACKGROUND AND OBJECTIVES: Evaluation of long-term results using a thermal balloon endometrial ablation technique to treat menorrhagia and hypermenorrhea, considered dysfunctional uterine bleedings. METHODS: A single-arm, prospective study with long-term follow-up of 48 months at the department of obstetrics and gynecology, University of Kiel, Germany. Following hysteroscopic evaluation of the uterine cavity and fractionated curettage, the Cavaterm endometrial thermal ablation technique was performed on 70 patients over the age of 40 with menorrhagia and hypermenorrhea in whom medical treatment had previously failed. The study included a group of 10 patients with adenomyosis and uterine fibroids. RESULTS: In 65 patients, a complete 48-month follow-up evaluation was possible: 58% of patients reported amenorrhea and 33% hypomenorrhea. Nine percent of patients remained eumenorrheic. Fifty percent of the small group with failed indications for the procedure had to undergo a hysterectomy. CONCLUSIONS: The Cavaterm thermal coagulation system in the earlier mode of application (15 minutes at a temperature of 70 degrees C and a pressure of 200 mm Hg) is a safe and highly effective method of endometrial ablation resulting in a minimal amount of posttreatment menstrual bleeding.

[dr_medvedev]

Любопытно, что метод успешно применяется даже при небольших миомах:

Thermal Balloon Ablation in Myoma-Induced Menorrhagia under Local Anesthesia
Mehmet Emin Soysala, Seyide Kara Soysala, Kubilay Vicdanb

aDepartment of Obstetrics and Gynecology, Pamukkale University Medical Center, Denizli, and
bDepartment of Obstetrics and Gynecology, Bayindir Medical Center, Ankara, Turkey


Address of Corresponding Author

Gynecologic and Obstetric Investigation 2001;51:128-133 (DOI: 10.1159/000052908)

Key Words
Thermal balloon ablation
Menorrhagia
Myoma

Abstract

Objective: Our purposes were to compare the impact of surgery on menstrual blood flow reduction and on the increase in hemoglobin values as primary endpoints at 12 months, and operating time, complication rates, postoperative pain scores at 12 h and surgically induced amenorrhea rates at 12 months as secondary endpoints after roller ball endometrial ablation or thermal balloon ablation for myoma-induced menorrhagia. Materials and Methods: Menorrhagic women (documented by a validated pad scoring system) over 40 years of age, with a mobile myomatous uterus smaller than 12-week pregnancy, were enrolled in a prospective randomized trial to compare endometrial roller ball ablation and thermal balloon ablation after pharmacological endometrial thinning. One year after surgery, primary and secondary endpoints in both groups were compared. Results: Forty-five subjects underwent endometrial thermal balloon ablation under local anesthesia and 48 underwent endometrial roller ball ablation under general anesthesia. Statistically significant but similar decreases in mean pictorial blood assessment score and increases in mean hemoglobin values were noted for both groups at 12 months. Those who underwent endometrial roller ball ablation had experienced significantly more intraoperative complications. Conclusion: Thermal balloon ablation under local anesthesia for myoma-induced menor- rhagia provided both significant and statistically similar reductions in menstrual blood flow and increases in hemoglobin values with no intraoperative complication compared to roller ball endometrial ablation.

Copyright © 2001 S. Karger AG, Basel

Author Contacts

Assoc. Prof. Dr. Mehmet Emin Soysal
PK 7
TR-20100 Denizli (Turkey)
Tel. +90 258 265 77 71, Fax +90 258 241 70 39
E-Mail [Ссылки доступны только зарегистрированным пользователям ]

Article Information

Received: Received: April 20, 2000
Accepted after revision: August 31, 2000
Number of Print Pages : 6
Number of Figures : 1, Number of Tables : 4, Number of References : 35

[dr_medvedev]

Вообще очень многообещающий метод, особенно на нашем постсоветском пространстве. Можно модифицировать с использованием обычных внутриматочных и даже Фолеевских катетеров!
Вот еще одно большое исследование:

Human Reproduction, Vol. 18, No. 5, 1082-1087, May 2003
© 2003 European Society of Human Reproduction and Embryology

Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicentre follow-up study
Nazar N. Amso1,11, Hervé Fernandez2, George Vilos3, Claude Fortin4, Peter McFaul5, Monika Schaffer6, P.F.M. Van der Heijden7, Marlies Y. Bongers8, Barry Sanders9 and Bernard Blanc10

1 Department of Obstetrics and Gynaecology, University of Wales College of Medicine and the University Hospital of Wales, Cardiff CF14 4XN, UK, 2 H. A. Béclère, Clamart, France, 3 St Joseph’s Health Centre, London, Canada, 4 Clin Méd. Chateauguay, Canada, 5 Belfast City Hospital, Belfast, UK, 6 University Clinic Obstetrics and Gynaecology, Graz, Austria, 7 Twenteborg H., Almelo, The Netherlands, 8 St Joseph’s Hospital, Veldhoven, The Netherlands, 9 University of British Columbia, Vancouver, Canada and 10 Hôpital Conception, Marseilles, France


BACKGROUND: Initial reports from observational and randomized trials of uterine endometrial thermal balloon therapy (UBT) suggested good results as judged by return to eumenorrhoea or less and patient satisfaction. Long-term follow-up data remained limited by the small numbers of patients and duration of follow-up. We present long-term (4–6 years) follow-up data from a cohort of women previously treated with UBT for menorrhagia. METHODS: Of the 260 questionnaires sent to women eligible for long-term follow-up from 10 centres, 188 (72%) replies were received. The primary outcome measure was avoidance of hysterectomy. RESULTS: In women who responded to the questionnaire, 25 had undergone hysterectomy and 21 had had repeat ablation. At 4–6 years after UBT, the probability of avoiding hysterectomy was 86% of all women, and of avoiding re-ablation was 88% of non-hysterectomized women. Overall, the probability of avoiding any surgery was 75%. Women with an axial or retroverted uterus were at greater risk of hysterectomy or re-ablation. Among the participants, 47% of the non-hysterectomized women were amenorrhoeic, 30% were hypomenorrhoeic, 13.6% were eumenorrhoeic and 8.5% had heavy periods. CONCLUSIONS: This is the first long-term follow-up report of a second-generation endometrial ablation procedure and confirms our initial experience. The high rate of hysterectomy avoidance over 5 years or more is very encouraging for this technology.

[dr_medvedev]

Вот нашел всего лишь описание случая:

J Reprod Med. 2001 Oct;46(10):933-6. Related Articles, Links

Balloon thermoablation in a woman with complex endometrial hyperplasia with atypia. A case report.

Minassian VA, Mira JL.

Departments of Obstetrics and Gynecology and of Pathology and Laboratory Medicine, Texas Tech University Health Sciences Center, 3601 4th Street, Lubbock, TX 79430, USA. [Ссылки доступны только зарегистрированным пользователям ]

BACKGROUND: Endometrial ablation is an alternative to hysterectomy in patients with menorrhagia refractory to medical therapy. The histologic changes in the hyperplastic endometrium secondary to endometrial ablation are not well understood. CASE REPORT: A 44-year-old woman, gravida 4, para 4, had menorrhagia, was at high risk for medical treatment and underwent thermal balloon ablation. The dilatation and curettage specimen at the time of the procedure revealed complex hyperplasia of the endometrium with atypia. Subsequently a hysterectomy was performed, and the pathology specimen showed scarring, fibrosis and focal, weakly proliferative phase endometrium. There was no evidence of hyperplasia or malignancy. CONCLUSION: Endometrial ablation with a thermal balloon seems to have resulted in resolution of endometrial hyperplasia. However, hyperplasia of the endometrium should still be a contraindication to such a procedure because of the inability to accurately assess the endometrium after ablation.

Publication Types:
Case Reports

Выглядит не очень ободряюще
Может был у кого-то опыт?

[silver]

в отделении где я работаю -метод периодически используется
процедура проста однако описаны проблемы связанные с ней
попытаюсь выяснить прелиминарные результаты

[dr_medvedev]

Сообщение от silver

в отделении где я работаю -метод периодически используется
процедура проста однако описаны проблемы связанные с ней
попытаюсь выяснить прелиминарные результаты

Спасибо. Жду от Вас информации.