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Transcervical endometrial cryoablation (ECA) for menorrhagia
International Journal of Gynecology & Obstetrics 47 (1994) 135-140
Article
Transcervical endometrial cryoablation R. Pittrof*, Department
of Obstetrics
(ECA) for menorrhagia
S. Majid, A. Murray
and Gynecology,
Arrowe Park Hospital, Birkenhead L.49 5PE. UK
Received 18 March 1994; revision received 15 June 1994; accepted 30 June 1994
Abstract Objective: To evaluate endometrial cryoablation (ECA) as a treatment for menorrhagia. Method: Prospective study of 67 women. ECA uses the Joule Thompson principle of expanding gases. The ECA probe has a channel to inject saline solution into the uterine cavity. The probe is introduced into the uterine cavity, which is distended with 5 ml saline solution. The device is activated for two freeze-thaw cycles. The saline solution forms an ice mold of the uterine cavity which can be.observed by ultrasound scan. Results: No surgical or long-term complications were observed. Twothirds of patients followed up for > 3 months were completely satisfied. Conclusions:ECA is technically very easy, can be learned quickly, is free of complications and led to improvement of menstrual symptoms in 63% of patients followed up for 3-18 months. The device is virtually maintenance-free and requires only a small initial investment, while running costs are negligible. Keywords:
Cryosurgery; Menorrhagia; Minimally invasive surgery
1. Introduction Each year in the UK about 70 000 hysterectomies are performed, two-thirds of which could be treated with minimally invasive procedures for menorrhagia [l]. Established methods such as transcervical endometrial resection or ablation carry a risk of uterine perforation [2-41 and its sequelae (fluid overload [5-71, air embolism [8,9] and hemorrhage [lo]), are technically difficult and require a high initial investment. There is therefore * Corresponding author, Department of Obstetrics and Gynaecology, King’s College Hospital, London SE5 8RX. UK, Tel.: (+44) 071-487 5050; Fax: (+44) 071-487 5850. 0 1994 International 0020-7292/94/$07.00 SD/ 0020-7292(94)02193-3
Federation
of Gynecology
a need for a technically easy procedure, with a low complication rate and low initial and running costs. The present study investigated such a method. The study was approved by the Regional Ethics Committee and informed consent was obtained from all patients who participated in the study. 2. Subjects and methods Sixty-seven women who would have otherwise undergone hysterectomy for prolonged menorrhagia (mean 6 years, range l-25 years) participated in the trial. Within the previous 6 months all patients and Obstetrics
had undergone
a transvaginal
ultra-
136
R. Pittrofei
al. /ht.
J. Gynecol. Obsret. 47 (1994) 135-140
sound scan, endometrial biopsy or dilatation and curettage (D & C), cervical smear and swabs and high vaginal swabs. Significant endometrial or uterine pathology was excluded in all but one patient who had a tamoxifen-associated endometrial polyp which was removed at the time of endometrial cryoablation (ECA). The mean age of the patients was 34 years (range 28-50 years) and all patients had completed their family. All patients classified their menstrual loss as heavy and unresponsive to medical treatment. Preoperatively patients received a single injection of goserelin 3.6 mg, leuprorelin 3.75 mg, medroxyprogesterone acetate injection 150 mg or danazol600 mg daily, or buserelin 900 pg daily for 3-6 weeks. All patients who did not use a permanent method of contraception underwent sterilization. All procedures were performed under general anesthesia. Each patient received 1.2 g coamoxiclav intravenously at induction of anesthesia and 500 mg ketoprofen was given intramuscularly at the end of the procedure. The patients were positioned as for D & C. A formal examination under anesthesia was performed and position of the uterus and length of the uterine cavity noted. The cervix was then dilated to Hegar No. 8. The ECA probe looks similar to a No. 8 Hegar cervical dilator. Its distal 5 cm can be cooled to -45°C using the Joule Thompson principle of expanding CO2 or N20 (BOC cylinders). The proximal part of the device is insulated to prevent cold injury to the cervix and vagina. The probe has a distension channel and a thermocouple, which was added after the first 6 months of the trial. The cryodevice was introduced into the uterus to the full length of the uterine cavity with the tip pointing towards one cornu. The uterus was then distended with 5 ml isotonic saline solution which forms a coupling medium between the endometrium and the probe. The cryodevice was activated for 5 min and an ice mold formed inside the uterine cavity. Filling of the uterine cavity with the distension medium and its conversion to ice was observed using transvaginal and transabdominal ultrasound in the first three patients. After 5 min, the thawing mechanism of the device was activated, the device was removed and the complete
cycle (insertion of the device, distension of the uterine cavity, activation and removal of the device) was repeated with the cryoprobe pointing towards the other cornu. Rectal and esophageal temperature was measured in the first five patients. ECA can be performed as a day case treatment and patients are usually discharged the same or the following day. For the first 12 months of the trial patients received co-amoxiclav 750 mg and mefenamic acid 500 mg 8 hourly for 3 days and were asked to abstain from intercourse until the discharge had settled. Postoperative follow-up was arranged at 6 weeks and then at 3-monthly intervals. Menstrual and urinary symptoms, vaginal discharge, premenstrual tension and frequency of sexual intercourse were assessed preoperatively retrospectively and the same symptoms and return to normal household work and sexual activity were assessed in the first 18 patients in a prospective but subjective fashion by the patient postoperatively. All patients and their general practitioners were asked to report any complications. Satisfaction with the procedure was assessed in all patients. 3. Results All ECAs were completed within 15 min and the ECA probe was not activated for more than 10 min in any case. No surgical complications occurred. Tubal spillage of uterine distension fluid was not observed in the 31 patients who underwent simultaneous laparoscopic sterilization. In all cases, where laparoscopy was performed blanching of the uterine serosa was noted. This was more noticeable towards the uterine cornu to which the probe was pointing. The ice mold of the uterine cavity melted within 1 min once the thawing mechanism of the ECA probe was activated. Central body temperature did not drop more than 1.4”C in any of the monitored patients. Operative blood loss was less than 5 ml in all cases. The only postoperative complications were transient urinary frequency and urgency and moderate pelvic pain. Three patients required one dose of intramuscular morphine. Two patients were discharged within 6 h and 60 patients within 24 h of their surgery. The first three patients who
R. Pit&of et al. /ht.
J. Gynecol. Obstet. 47 (1994) 135-140
Table 1 ECA audit
became amenorrheic. No patient had any longterm complications and vaginal discharge; urinary symptoms and pelvic pain settled in all patients within 2 weeks. All patients returned to normal social and sexual activity within 3 months (mean 2 weeks, range 1- 12 weeks). Frequency of sexual intercourse, dysmenorrhea or premenstrual tension was unaffected or improved following ECA in the first 18 patients. Twenty-two patients underwent hysterectomy following failed ECA. No pathology attributable to the ECA was noticed in any of them. There were no cases of intrauterine adhesions among the cases of failed ECA and the endometrium appeared macroscopically and histologically normal. Follow-up was either for 18 months or until the patient requested hysterectomy for persistent menstrual problems. Thirteen of the 67 patients were excluded from further analysis. In seven of them follow-up had not reached 3 months, while six patients underwent ECA without adhering to the protocol (Table 1). Of the 19 patients treated until 1 October 1992, three were excluded from further analysis because of protocol violations. Ten of the remaining 16 patients (62.5%) were completely and persistently satisfied with the outcome and were discharged from follow-up 18 months after the procedure. All
Patient satisfaction Total no. of procedures performed until 9 December 1993 No. of surgical complications No. of long-term complications No. of procedures performed with working device No. of procedures performed with non-working device Duration of ECA 5-10 min Duration of ECA I I-15 min Duration of ECA > 15 min
67 0 0 46
22 (63.6%“)
21
3 (14.2%)
137
60 7 0
“Excluding six patients with protocol violation and seven patients with follow-up < 3 months. Protocol violations: tamoxifen-associated polyp/no preparation, n = 1 (failure); no preoperative endometrial preparation. n = I (failure); endometrial thickness > 5 mm, n = 4 (success. n = 1; failure, n = 3).
underwent ECA were kept for observation for 48 h. Two further patients who were admitted for more than 24 h underwent other concomitant surgery (minilaparotomy and pelvic floor repair). No patient was lost to follow-up and 60 were followed up for more than 3 months. No patient
Table 2 Evaluation of 39 ECAS performed with working equipment (follow-up > 3 months) Patient assessment of ECA
Y
N
Y
N
Laparoscopic tubal ligation ~ Y N
5 6
16 12
2 I
I9 17
12 8’
Hysteroscopy
D&C
Satisfied Failed ECA
Pre/postoperative treatment
Performed before or during ECA
9= 10
Vasectomy
____ Y N 7 5
14 13
Danazol LHRH 7 9”
16b 7b
Other 1 2”
BT~~ patients with protocol violation. bOne patient with protocol violation. D L C at the time of ECA did not improve the result of ECA. The result of ECA is not affected by the presence of patent tubes. Patients receiving LHRH or medroxyprogesterone acetate had a significantly (P < 0.05) better outcome (70.8% success rate) than patients receiving danazol or no pre-ECA treatment (38.9% success rate).
R. Pittrofet
138
al. /ht.
J. Gynecol. Obstet. 47 (1994) 135-140
Table 3 Preoperative endometrial thickness (ET) in patients treated with a working ECA probe (n = 39, follow up >3 months) ET(mm)2 Success Failure
3
I
3
4
5
6
7
8
>8
Not recorded
6 3
7 7
I 0
0 1”
1” 0
0 2b
0 0
4 3b
“One patient with protocol violation. bTwo patients with protocol violation. Patients with an endometrial thickness > 5 mm were more hkely to have a failed ECA but this was not statistically signilicant (P > 0.1).
were satisfied at their 3-month follow-up appointment and none developed any menstrual problems later. These patients are presented elsewhere [ 111. Of the 21 patients treated between 1 October 1992 and 18 March 1993, only three (14.2%; follow-up duration 8, 9 and 10 months) were satisfied with the result of the procedure. The remaining 18/21 patients opted to have a hysterectomy. Examination of the ECA console in March 1993 revealed a leak so that most of the pressurized gas bypassed the ECA probe. The console was replaced and a thermocouple was incorporated into the ECA probe. Twenty-seven patients were treated with the new ECA probe and console. Three patients were treated despite protocol violations (Table 1) and seven patients have not yet been followed up for 3 months. Improvement of menstrual symptoms was inadequate in five patients at their 3-month followup appointment and they were offered a hysterectomy. Twelve patients (12/17, 70.6%) were satisfied with the treatment (duration of follow up: 3-8 months). Other variables are presented in Tables 1-3. 4. Discussion Minimally invasive management of menorrhagia has been shown to be cost-effective when compared with hysterectomy [ 12,131. Transcervital endometrial resection [lo], ablation using laser [ 141, roller ball [15] or radiofrequencyinduced heat [16] are established methods for the treatment of menorrhagia. They require however a
high initial investment and extensive training and/or have been associated with serious complications [2-lo]. There is consequently the need for a simple and safe method which does not require expert skills in gynecological endoscopy. Transvaginal ultrasonography and endometrial biopsy have been reviewed as screening and diagnostic tools for endometrial pathology by Wikland et al. [ 171. Preoperative preparation of the endometrium induces endometrial atrophy. This not only increases the success rate of ECA but also increases the diagnostic accuracy of transvaginal ultrasonography, as an endometrial thickness <4 mm on transvaginal ultrasonography virtually excludes endometrial pathology including endometrial cancer [18]. It should therefore not be necessary to perform a hysteroscopy before commencing an ECA. ECA was one of the first methods used for minimally invasive treatment of menorrhagia [ 1g-221. Complications have rarely been reported [23,24]. Our results with ECA, particularly the absence of any surgical complications, are encouraging. While we have no conclusive proof that patients 20-40 were treated with a non-working ECA device, the impressive improvement of the results once the console had been replaced strongly suggests this. One could almost say that 21 patients treated with a non-working device could serve as a control group as neither surgeon nor patient were aware of the problem at the time. This excludes a significant placebo effect of the procedure. The technical problem in the standard console (and not in the probe itself) has now been overcome and the incorporation of a thermocouple into the ECA device enables the surgeon to monitor its function. Patients who received luteinizing hormonereleasing hormone (LHRH) analogs and who were treated with a working device had a satisfaction rate of 71%. This is less than that reported for other treatment methods performed in centers of excellence by surgeons dedicated to the procedure [25], but ECA has several advantages over alternative methods of minimally invasive surgery for menorrhagia: (1) ECA is as simple as D & C. The
R. Pittrof et al. /ht.
J. Gynecol. Obstet. 47 (1994) 13.5-140
device has a familiar shape; uterine perforation did not occur and appears extremely unlikely. ECA can therefore be performed by junior staff as a day case procedure. (2) ECA is simple to use and has virtually no learning curve. It would thus be the ideal tool for a surgeon without extensive training in hysteroscopic surgery. (3) ECA appears virtually free of acute and long-term complications. A maximum of 10 ml isotonic saline is used as a uterine distension medium and fluid overload cannot become a problem. The ECA device is thoroughly pressure-tested so that no pressurized gas can leak into the uterus. Air embolism is therefore extremely unlikely. The familiar and blunt shape of the device, which does not need to be moved within the uterine cavity, safeguards against uterine perforation. Other methods of endometrial ablation or resection thin the uterus and perforation becomes more likely during the procedure. ECA does not remove any tissue. As the endometrium freezes, perforation becomes even less likely. The formation of intrauterine adhesions could interfere with the subsequent evaluation of irregular uterine bleeding. The device is cheap (< ESOOO),almost maintenance-free and has very low running costs. Following the addition of a thermocouple its performance can easily be monitored. This compares favorably with laser technology with equipment costs of f50-100 000 [25] and the need for a specially adapted theater. (5) While 64% of patients treated with a working device improved, none became amenorrheic. Light or normal menstruation is culturally more acceptable to some patients than amenorrhea. 5. Conclusion Transcervical ECA using a uterine distension medium is faster, cheaper and easier to perform than alternative methods of endometrial ablation/resection. While visually guided methods of endometrial destruction demand a high level of skill, ECA can be performed by anyone who can safely perform a D & C. ECA performed at the time of diagnostic D & C can therefore become part of the diagnostic examination of patients with menorrhagia, provided suitable endometrial preparation has been given.
139
ECA can replace some hysterectomies or transcervital endometrial resection or ablation particularly where resources are limited. Acknowledgment We would like to thank Mr Gibson, Mr Coleman and Dr Sigger of the Surgical Technology Group, Andover, UK, for their invaluable help during the development of the probe and the running of the trial. References 111Rutherford AJ, Glass MR, Wells M. Patient selection for hysteroscopic endometrial resection. Br J Obstet Gynaecol 1991; 98: 228. 121Pittrof R, Darwish DH, Shabib G. Near fatal uterine perforation during transcervical endometrial resection. Lancet 1991; 338: 197. 131 Perry CP, Daniel1 JF, Gimpelson RJ. Bowel injury from Nd:YAG endometrial ablation. J Gynaecol Surg 1990; 6: 199.
141 Magos AL, Bauman R, Lockwood GM, Tumbull AC. Safety of tramcervical endometrial resection. Lancet 1990, i: 44. I51 Garry R, Hasham F, Korki MS, Monney P. A multicentre collaborative study into the treatment of menorrhagia by Nd-YAG laser ablation of the endometrium. Br J Obstet Gynaecol 1991; 98: 357. 161Garry R, Monney P, Hasham F. Korki MS. A uterine distension system to prevent fluid absorption during NdYAG laser endometrial ablation. Gynaecol Endosc 1992; 1: 23. 171 Baumann R, Magos AL, Kay JSD, Turnbull AC. Absorption of glycine irrigation solution during transcervital resection of the endometrium. Br Med J 1990; 300: 394. 181 Baggish MS, Daniel1 JF. Catastrophic injury secondary to the use of coaxial gas cooled artificial sapphire tips for intra uterine surgery: a report of 5 cases. Laser Surg Med 1989; 9: 581. 191 Wood SM, Roberts FL. Air embolism during transcervital endometrial resection of the endometrium. Br Med J 1990; 300: 945. 1101 Magos AL, Bauman R, Lockwood GM, Turnbull AC. Experience with the first 250 endometrial resections for menorrhagia. Lancet 1991; 337: 1074. 1111 Pittrof R, Majid S, Murray A. Initial experience with transcervical endometrial cryoablation of the endometrium using saline as a uterine distension medium. Min Invas Ther 1993; 2: 69. 1121 Rutherford AJ, Glass MR. Management of menorrhagia. Br Med J 1990; 301: 290.
140
R. Pittrof et al. /ht.
J. Gynecol. Obstet. 47 (1994) 135-140
[131 Macdonald R. Modern management of menorrhagia. Br J Obstet Gynaecol 1990; 97: 3. (141 Goldrath M. Hysteroscopic laser ablation of the endometrium. In: Sharp F, Jordan J, editors. Gynaecological laser surgery. Proceedings of the RCOG 15th Study Group. New York: Perinatology Press, 1985; 263. [ 151 Vancaille TG. Electrocoagulation of the endometrium with the ball end resectoscope. Obstet Gynecol 1989; 74: 425. 1161 Phipps JH, Lewis BV, Roberts T, Prior MV, Hand JW, Elder M, et al. Treatment of functional menorrhagia by radiofrequency-induced thermal endometrial ablation. Lancet 1990; i: 374. 1171 Wikland M, Grandberg S, Karlson B. Replacing diagnostic curettage by vaginal ultrasound. Eur J Obstet Gynecol Reprod Biol 1993; 49: 35. [I81 Osmers R, Volksen M, Schauer A. Vaginosonography for early detection of endometrial carcinoma? Lancet 1990; 335: 1569.
[I91 Cahan WG, Brockunier A Jr. Cryosurgery of the uterine cavity. Am J Obstet Gynecol 1967; 99: 138. [20] Drogemueller W, Greer B, Makowski E. Preliminary observations of cryoablation of the endometrium. Am J Obstet Gynecol 1970; 107: 958. [2l] Drogemueller W, Greer B. Makowski cryosurgery in patients with dysfunctional uterine bleeding. Obstet Gynecol 1971; 38: 256. [22] Drogemueller W, Makowski E, Macsalka R. Destruction of the endometrium by cryosurgery. Am J Obstet Gynecol 1971; 110: 467. [23] Burke L, Rubin HK, Kim I. Uterine abscess formation secondary to endometrial cryosurgery. Obstet Gynecol 1973; 41: 224. [24] Magos AL. Endometrial ablation for menorrhagia. In: Studd J, editor. Progress in obstetrics and gynaecology. Vol. 9. Edinburgh: Churchill Livingstone, 1991; 375. [25] Garry R. Hysteroscopic alternatives to hysterectomy. Br J Obstet Gynaecol 1990; 97: 199.
Article
Transcervical endometrial cryoablation R. Pittrof*, Department
of Obstetrics
(ECA) for menorrhagia
S. Majid, A. Murray
and Gynecology,
Arrowe Park Hospital, Birkenhead L.49 5PE. UK
Received 18 March 1994; revision received 15 June 1994; accepted 30 June 1994
Abstract Objective: To evaluate endometrial cryoablation (ECA) as a treatment for menorrhagia. Method: Prospective study of 67 women. ECA uses the Joule Thompson principle of expanding gases. The ECA probe has a channel to inject saline solution into the uterine cavity. The probe is introduced into the uterine cavity, which is distended with 5 ml saline solution. The device is activated for two freeze-thaw cycles. The saline solution forms an ice mold of the uterine cavity which can be.observed by ultrasound scan. Results: No surgical or long-term complications were observed. Twothirds of patients followed up for > 3 months were completely satisfied. Conclusions:ECA is technically very easy, can be learned quickly, is free of complications and led to improvement of menstrual symptoms in 63% of patients followed up for 3-18 months. The device is virtually maintenance-free and requires only a small initial investment, while running costs are negligible. Keywords:
Cryosurgery; Menorrhagia; Minimally invasive surgery
1. Introduction Each year in the UK about 70 000 hysterectomies are performed, two-thirds of which could be treated with minimally invasive procedures for menorrhagia [l]. Established methods such as transcervical endometrial resection or ablation carry a risk of uterine perforation [2-41 and its sequelae (fluid overload [5-71, air embolism [8,9] and hemorrhage [lo]), are technically difficult and require a high initial investment. There is therefore * Corresponding author, Department of Obstetrics and Gynaecology, King’s College Hospital, London SE5 8RX. UK, Tel.: (+44) 071-487 5050; Fax: (+44) 071-487 5850. 0 1994 International 0020-7292/94/$07.00 SD/ 0020-7292(94)02193-3
Federation
of Gynecology
a need for a technically easy procedure, with a low complication rate and low initial and running costs. The present study investigated such a method. The study was approved by the Regional Ethics Committee and informed consent was obtained from all patients who participated in the study. 2. Subjects and methods Sixty-seven women who would have otherwise undergone hysterectomy for prolonged menorrhagia (mean 6 years, range l-25 years) participated in the trial. Within the previous 6 months all patients and Obstetrics
had undergone
a transvaginal
ultra-
136
R. Pittrofei
al. /ht.
J. Gynecol. Obsret. 47 (1994) 135-140
sound scan, endometrial biopsy or dilatation and curettage (D & C), cervical smear and swabs and high vaginal swabs. Significant endometrial or uterine pathology was excluded in all but one patient who had a tamoxifen-associated endometrial polyp which was removed at the time of endometrial cryoablation (ECA). The mean age of the patients was 34 years (range 28-50 years) and all patients had completed their family. All patients classified their menstrual loss as heavy and unresponsive to medical treatment. Preoperatively patients received a single injection of goserelin 3.6 mg, leuprorelin 3.75 mg, medroxyprogesterone acetate injection 150 mg or danazol600 mg daily, or buserelin 900 pg daily for 3-6 weeks. All patients who did not use a permanent method of contraception underwent sterilization. All procedures were performed under general anesthesia. Each patient received 1.2 g coamoxiclav intravenously at induction of anesthesia and 500 mg ketoprofen was given intramuscularly at the end of the procedure. The patients were positioned as for D & C. A formal examination under anesthesia was performed and position of the uterus and length of the uterine cavity noted. The cervix was then dilated to Hegar No. 8. The ECA probe looks similar to a No. 8 Hegar cervical dilator. Its distal 5 cm can be cooled to -45°C using the Joule Thompson principle of expanding CO2 or N20 (BOC cylinders). The proximal part of the device is insulated to prevent cold injury to the cervix and vagina. The probe has a distension channel and a thermocouple, which was added after the first 6 months of the trial. The cryodevice was introduced into the uterus to the full length of the uterine cavity with the tip pointing towards one cornu. The uterus was then distended with 5 ml isotonic saline solution which forms a coupling medium between the endometrium and the probe. The cryodevice was activated for 5 min and an ice mold formed inside the uterine cavity. Filling of the uterine cavity with the distension medium and its conversion to ice was observed using transvaginal and transabdominal ultrasound in the first three patients. After 5 min, the thawing mechanism of the device was activated, the device was removed and the complete
cycle (insertion of the device, distension of the uterine cavity, activation and removal of the device) was repeated with the cryoprobe pointing towards the other cornu. Rectal and esophageal temperature was measured in the first five patients. ECA can be performed as a day case treatment and patients are usually discharged the same or the following day. For the first 12 months of the trial patients received co-amoxiclav 750 mg and mefenamic acid 500 mg 8 hourly for 3 days and were asked to abstain from intercourse until the discharge had settled. Postoperative follow-up was arranged at 6 weeks and then at 3-monthly intervals. Menstrual and urinary symptoms, vaginal discharge, premenstrual tension and frequency of sexual intercourse were assessed preoperatively retrospectively and the same symptoms and return to normal household work and sexual activity were assessed in the first 18 patients in a prospective but subjective fashion by the patient postoperatively. All patients and their general practitioners were asked to report any complications. Satisfaction with the procedure was assessed in all patients. 3. Results All ECAs were completed within 15 min and the ECA probe was not activated for more than 10 min in any case. No surgical complications occurred. Tubal spillage of uterine distension fluid was not observed in the 31 patients who underwent simultaneous laparoscopic sterilization. In all cases, where laparoscopy was performed blanching of the uterine serosa was noted. This was more noticeable towards the uterine cornu to which the probe was pointing. The ice mold of the uterine cavity melted within 1 min once the thawing mechanism of the ECA probe was activated. Central body temperature did not drop more than 1.4”C in any of the monitored patients. Operative blood loss was less than 5 ml in all cases. The only postoperative complications were transient urinary frequency and urgency and moderate pelvic pain. Three patients required one dose of intramuscular morphine. Two patients were discharged within 6 h and 60 patients within 24 h of their surgery. The first three patients who
R. Pit&of et al. /ht.
J. Gynecol. Obstet. 47 (1994) 135-140
Table 1 ECA audit
became amenorrheic. No patient had any longterm complications and vaginal discharge; urinary symptoms and pelvic pain settled in all patients within 2 weeks. All patients returned to normal social and sexual activity within 3 months (mean 2 weeks, range 1- 12 weeks). Frequency of sexual intercourse, dysmenorrhea or premenstrual tension was unaffected or improved following ECA in the first 18 patients. Twenty-two patients underwent hysterectomy following failed ECA. No pathology attributable to the ECA was noticed in any of them. There were no cases of intrauterine adhesions among the cases of failed ECA and the endometrium appeared macroscopically and histologically normal. Follow-up was either for 18 months or until the patient requested hysterectomy for persistent menstrual problems. Thirteen of the 67 patients were excluded from further analysis. In seven of them follow-up had not reached 3 months, while six patients underwent ECA without adhering to the protocol (Table 1). Of the 19 patients treated until 1 October 1992, three were excluded from further analysis because of protocol violations. Ten of the remaining 16 patients (62.5%) were completely and persistently satisfied with the outcome and were discharged from follow-up 18 months after the procedure. All
Patient satisfaction Total no. of procedures performed until 9 December 1993 No. of surgical complications No. of long-term complications No. of procedures performed with working device No. of procedures performed with non-working device Duration of ECA 5-10 min Duration of ECA I I-15 min Duration of ECA > 15 min
67 0 0 46
22 (63.6%“)
21
3 (14.2%)
137
60 7 0
“Excluding six patients with protocol violation and seven patients with follow-up < 3 months. Protocol violations: tamoxifen-associated polyp/no preparation, n = 1 (failure); no preoperative endometrial preparation. n = I (failure); endometrial thickness > 5 mm, n = 4 (success. n = 1; failure, n = 3).
underwent ECA were kept for observation for 48 h. Two further patients who were admitted for more than 24 h underwent other concomitant surgery (minilaparotomy and pelvic floor repair). No patient was lost to follow-up and 60 were followed up for more than 3 months. No patient
Table 2 Evaluation of 39 ECAS performed with working equipment (follow-up > 3 months) Patient assessment of ECA
Y
N
Y
N
Laparoscopic tubal ligation ~ Y N
5 6
16 12
2 I
I9 17
12 8’
Hysteroscopy
D&C
Satisfied Failed ECA
Pre/postoperative treatment
Performed before or during ECA
9= 10
Vasectomy
____ Y N 7 5
14 13
Danazol LHRH 7 9”
16b 7b
Other 1 2”
BT~~ patients with protocol violation. bOne patient with protocol violation. D L C at the time of ECA did not improve the result of ECA. The result of ECA is not affected by the presence of patent tubes. Patients receiving LHRH or medroxyprogesterone acetate had a significantly (P < 0.05) better outcome (70.8% success rate) than patients receiving danazol or no pre-ECA treatment (38.9% success rate).
R. Pittrofet
138
al. /ht.
J. Gynecol. Obstet. 47 (1994) 135-140
Table 3 Preoperative endometrial thickness (ET) in patients treated with a working ECA probe (n = 39, follow up >3 months) ET(mm)2 Success Failure
3
I
3
4
5
6
7
8
>8
Not recorded
6 3
7 7
I 0
0 1”
1” 0
0 2b
0 0
4 3b
“One patient with protocol violation. bTwo patients with protocol violation. Patients with an endometrial thickness > 5 mm were more hkely to have a failed ECA but this was not statistically signilicant (P > 0.1).
were satisfied at their 3-month follow-up appointment and none developed any menstrual problems later. These patients are presented elsewhere [ 111. Of the 21 patients treated between 1 October 1992 and 18 March 1993, only three (14.2%; follow-up duration 8, 9 and 10 months) were satisfied with the result of the procedure. The remaining 18/21 patients opted to have a hysterectomy. Examination of the ECA console in March 1993 revealed a leak so that most of the pressurized gas bypassed the ECA probe. The console was replaced and a thermocouple was incorporated into the ECA probe. Twenty-seven patients were treated with the new ECA probe and console. Three patients were treated despite protocol violations (Table 1) and seven patients have not yet been followed up for 3 months. Improvement of menstrual symptoms was inadequate in five patients at their 3-month followup appointment and they were offered a hysterectomy. Twelve patients (12/17, 70.6%) were satisfied with the treatment (duration of follow up: 3-8 months). Other variables are presented in Tables 1-3. 4. Discussion Minimally invasive management of menorrhagia has been shown to be cost-effective when compared with hysterectomy [ 12,131. Transcervital endometrial resection [lo], ablation using laser [ 141, roller ball [15] or radiofrequencyinduced heat [16] are established methods for the treatment of menorrhagia. They require however a
high initial investment and extensive training and/or have been associated with serious complications [2-lo]. There is consequently the need for a simple and safe method which does not require expert skills in gynecological endoscopy. Transvaginal ultrasonography and endometrial biopsy have been reviewed as screening and diagnostic tools for endometrial pathology by Wikland et al. [ 171. Preoperative preparation of the endometrium induces endometrial atrophy. This not only increases the success rate of ECA but also increases the diagnostic accuracy of transvaginal ultrasonography, as an endometrial thickness <4 mm on transvaginal ultrasonography virtually excludes endometrial pathology including endometrial cancer [18]. It should therefore not be necessary to perform a hysteroscopy before commencing an ECA. ECA was one of the first methods used for minimally invasive treatment of menorrhagia [ 1g-221. Complications have rarely been reported [23,24]. Our results with ECA, particularly the absence of any surgical complications, are encouraging. While we have no conclusive proof that patients 20-40 were treated with a non-working ECA device, the impressive improvement of the results once the console had been replaced strongly suggests this. One could almost say that 21 patients treated with a non-working device could serve as a control group as neither surgeon nor patient were aware of the problem at the time. This excludes a significant placebo effect of the procedure. The technical problem in the standard console (and not in the probe itself) has now been overcome and the incorporation of a thermocouple into the ECA device enables the surgeon to monitor its function. Patients who received luteinizing hormonereleasing hormone (LHRH) analogs and who were treated with a working device had a satisfaction rate of 71%. This is less than that reported for other treatment methods performed in centers of excellence by surgeons dedicated to the procedure [25], but ECA has several advantages over alternative methods of minimally invasive surgery for menorrhagia: (1) ECA is as simple as D & C. The
R. Pittrof et al. /ht.
J. Gynecol. Obstet. 47 (1994) 13.5-140
device has a familiar shape; uterine perforation did not occur and appears extremely unlikely. ECA can therefore be performed by junior staff as a day case procedure. (2) ECA is simple to use and has virtually no learning curve. It would thus be the ideal tool for a surgeon without extensive training in hysteroscopic surgery. (3) ECA appears virtually free of acute and long-term complications. A maximum of 10 ml isotonic saline is used as a uterine distension medium and fluid overload cannot become a problem. The ECA device is thoroughly pressure-tested so that no pressurized gas can leak into the uterus. Air embolism is therefore extremely unlikely. The familiar and blunt shape of the device, which does not need to be moved within the uterine cavity, safeguards against uterine perforation. Other methods of endometrial ablation or resection thin the uterus and perforation becomes more likely during the procedure. ECA does not remove any tissue. As the endometrium freezes, perforation becomes even less likely. The formation of intrauterine adhesions could interfere with the subsequent evaluation of irregular uterine bleeding. The device is cheap (< ESOOO),almost maintenance-free and has very low running costs. Following the addition of a thermocouple its performance can easily be monitored. This compares favorably with laser technology with equipment costs of f50-100 000 [25] and the need for a specially adapted theater. (5) While 64% of patients treated with a working device improved, none became amenorrheic. Light or normal menstruation is culturally more acceptable to some patients than amenorrhea. 5. Conclusion Transcervical ECA using a uterine distension medium is faster, cheaper and easier to perform than alternative methods of endometrial ablation/resection. While visually guided methods of endometrial destruction demand a high level of skill, ECA can be performed by anyone who can safely perform a D & C. ECA performed at the time of diagnostic D & C can therefore become part of the diagnostic examination of patients with menorrhagia, provided suitable endometrial preparation has been given.
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ECA can replace some hysterectomies or transcervital endometrial resection or ablation particularly where resources are limited. Acknowledgment We would like to thank Mr Gibson, Mr Coleman and Dr Sigger of the Surgical Technology Group, Andover, UK, for their invaluable help during the development of the probe and the running of the trial. References 111Rutherford AJ, Glass MR, Wells M. Patient selection for hysteroscopic endometrial resection. Br J Obstet Gynaecol 1991; 98: 228. 121Pittrof R, Darwish DH, Shabib G. Near fatal uterine perforation during transcervical endometrial resection. Lancet 1991; 338: 197. 131 Perry CP, Daniel1 JF, Gimpelson RJ. Bowel injury from Nd:YAG endometrial ablation. J Gynaecol Surg 1990; 6: 199.
141 Magos AL, Bauman R, Lockwood GM, Tumbull AC. Safety of tramcervical endometrial resection. Lancet 1990, i: 44. I51 Garry R, Hasham F, Korki MS, Monney P. A multicentre collaborative study into the treatment of menorrhagia by Nd-YAG laser ablation of the endometrium. Br J Obstet Gynaecol 1991; 98: 357. 161Garry R, Monney P, Hasham F. Korki MS. A uterine distension system to prevent fluid absorption during NdYAG laser endometrial ablation. Gynaecol Endosc 1992; 1: 23. 171 Baumann R, Magos AL, Kay JSD, Turnbull AC. Absorption of glycine irrigation solution during transcervital resection of the endometrium. Br Med J 1990; 300: 394. 181 Baggish MS, Daniel1 JF. Catastrophic injury secondary to the use of coaxial gas cooled artificial sapphire tips for intra uterine surgery: a report of 5 cases. Laser Surg Med 1989; 9: 581. 191 Wood SM, Roberts FL. Air embolism during transcervital endometrial resection of the endometrium. Br Med J 1990; 300: 945. 1101 Magos AL, Bauman R, Lockwood GM, Turnbull AC. Experience with the first 250 endometrial resections for menorrhagia. Lancet 1991; 337: 1074. 1111 Pittrof R, Majid S, Murray A. Initial experience with transcervical endometrial cryoablation of the endometrium using saline as a uterine distension medium. Min Invas Ther 1993; 2: 69. 1121 Rutherford AJ, Glass MR. Management of menorrhagia. Br Med J 1990; 301: 290.
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J. Gynecol. Obstet. 47 (1994) 135-140
[131 Macdonald R. Modern management of menorrhagia. Br J Obstet Gynaecol 1990; 97: 3. (141 Goldrath M. Hysteroscopic laser ablation of the endometrium. In: Sharp F, Jordan J, editors. Gynaecological laser surgery. Proceedings of the RCOG 15th Study Group. New York: Perinatology Press, 1985; 263. [ 151 Vancaille TG. Electrocoagulation of the endometrium with the ball end resectoscope. Obstet Gynecol 1989; 74: 425. 1161 Phipps JH, Lewis BV, Roberts T, Prior MV, Hand JW, Elder M, et al. Treatment of functional menorrhagia by radiofrequency-induced thermal endometrial ablation. Lancet 1990; i: 374. 1171 Wikland M, Grandberg S, Karlson B. Replacing diagnostic curettage by vaginal ultrasound. Eur J Obstet Gynecol Reprod Biol 1993; 49: 35. [I81 Osmers R, Volksen M, Schauer A. Vaginosonography for early detection of endometrial carcinoma? Lancet 1990; 335: 1569.
[I91 Cahan WG, Brockunier A Jr. Cryosurgery of the uterine cavity. Am J Obstet Gynecol 1967; 99: 138. [20] Drogemueller W, Greer B, Makowski E. Preliminary observations of cryoablation of the endometrium. Am J Obstet Gynecol 1970; 107: 958. [2l] Drogemueller W, Greer B. Makowski cryosurgery in patients with dysfunctional uterine bleeding. Obstet Gynecol 1971; 38: 256. [22] Drogemueller W, Makowski E, Macsalka R. Destruction of the endometrium by cryosurgery. Am J Obstet Gynecol 1971; 110: 467. [23] Burke L, Rubin HK, Kim I. Uterine abscess formation secondary to endometrial cryosurgery. Obstet Gynecol 1973; 41: 224. [24] Magos AL. Endometrial ablation for menorrhagia. In: Studd J, editor. Progress in obstetrics and gynaecology. Vol. 9. Edinburgh: Churchill Livingstone, 1991; 375. [25] Garry R. Hysteroscopic alternatives to hysterectomy. Br J Obstet Gynaecol 1990; 97: 199.