Table 11.3Myomectomy for treatment of uterine fibroids – comparative studies

Bibliographic informationStudy type and evidence levelNo. of patientsPatient characteristicsIntervention and comparisonFollow-upOutcome measuresEffect sizeSource of funding and additional comments
Agostini 2005470randomised

EL = 1−
94 randomised; 47 to oxytocin; 47 to placeboPopulation characteristics: Women; symptomatic uterine fibroids; scheduled for myomectomy

Baseline characteristics (oxytocin vs placebo):

Age = 40 vs 39

Weight of fibroid (g) = 286 (SD 206) vs 268 (SD 253)

Indication for surgery:

bleeding = 24 vs 21

Pelvic pain = 17 vs 20

Fertility = 6 vs 6

Country: France
oxytocin pre-treatment before myomectomy; placebo pre-treatment before myomectomy2 daysIntra-operative blood loss (ml); Change in haemoglobin (g/dl); blood transfusion ratesOxytocin (n = 47) vs placebo (n = 47)

Intra-operative blood loss (ml):

508 (SD 558) vs 451 (SD 336), P = 0.55

Change in haemoglobin (g/dl):

1.89 (SD 1.26) vs 1.93 (SD 1.2), P = 0.87

Blood transfusion rates:

7 of 47 vs 2 of 47, P = 0.09
Funding source: Not stated
Broder 2002425Comparative cohort study

EL = 2+
81 women undergoing abdominal myomectomy (AH) (n = 30) and uterine artery embolisation (UAE) (n = 51) for symptomatic fibroidsPopulation characteristics: Mean age:

UAE: 43.5 years
AH: 37.6 years (P < 0.001)

More likely to have previous myomectomy (P < 0.001)

Country: Germany
abdominal myomectomy vs uterine artery embolisation

abdominal myomectomy vs uterine artery embolisation
AH: mean 49 months

UAE: mean 46 months
Further invasive treatment

overall symptoms improvement

patient satisfaction
Further invasive treatment

UAE: 15 (29%) (12% hysterectomy, 16% myomectomy, 2% UAE)

AM: 1 (3%) (0=0.04) (3% hysterectomy, 0 myomectomy, 0 UAE)

overall symptoms improvement

UAE: 92%
AM: 90% (NS)

Patient satisfaction:

Dissatisfied: UAE: 6% AM: 21% (P = 0.06)

Clinical failure:

UAE: 39%
AM: 30% (NS)

Using logistic regression:

UAE more likely to have further invasive therapy (OR 12.5, 95%CI 1.4 to 110.1)
Funding source: not stated

Study summary: UAE more likely than AM to need further invasive therapy 3–5 years after index procedures
Celik 2003471Randomised; double-blind

EL = 1−
25 randomised; 12 placebo pre-treatment; 13 vaginal misoprostol (400 μg)Population characteristics: Women; symptomatic uterine fibroids; scheduled for myomectomy

Baseline (misoprostol vs placebo):

Age = 31.7 vs 32.2
Parity = 2.2 vs 2.3
BMI = 28.3 vs 28.5
Number of myoma = 5.5 vs 5.3
Largest myoma (mm) = 150.7 vs 154.2
Uterus size (weeks) = 15.7 vs 15.5
Intramural fibroids = 79% vs 81%
Subserous = 20% vs 18%

No statistical difference between groups

Country: Turkey
Misoprostol prior to myomectomy; placebo prior to myomectomy1 dayHaemoglobin levels (g/dl); Estimate intra-operative blood loss (ml); need for transfusions; operating time (min); length of stay (days)Misoprostol (n = 13) vs placebo (n = 12):

Haemoglobin levels (g/dl):

Pre-operative = 12.6 vs 12.3 (NS)
Post-operative 1 hour = 10.6 vs 9.7 (P < 0.05)
Postoperative 24 hours = 9.7 vs 8.9 (P < 0.05)

Estimate intra-operative blood loss (ml): 472 (SD 77) vs 621 (SD 121); P < 0.05

Need for transfusions: 2 vs 4 (P < 0.05)

Operating time (min): 48.5 vs 58

Length of stay (days): 4.2 vs 4.2
Funding source: Not stated
Corson 1994472Placebo; double-blind; randomised – double-blind

EL = 1−
64 women in total – not stated how many in each group.Population characteristics: Women; benign pathology – uterine fibroids, polyps; scheduled for hysteroscopic surgery – ablation, myomectomy, polypectomy. Variation in pre-treatment for women

Country: USA
Dilute vasopressin (20 units); placeboNot statedBlood loss (ml)Minimal operative bleeding: 81% in vasopressin vs 42% in placebo (P = 0.0002)Funding source: Not stated
Derman 1991459Comparative case series – chart review

EL = 2−
156 women (94 undergoing hysteroscopic submucous resection of uterine leiomyomas, 62 endometrial ablation)Population characteristics: 94 women undergoing submucous resection

Mean age: 36.6 years (26–50)

Indications: 83% menorrhagia/metrorrhagia, 16% infertility, 1% post-menopausal bleeding

Country: USA
hysteroscopic submucous resection an/or endometrial ablation

None
up to 9 yearsperi-operative complications

fertility

length of hospital stay

recurrence of symptom requiring repeat hysteroscopic or major abdominal surgery
Hysteroscopic submucous resection:

peri-operative complications:

0 heart failure
0 adverse reaction to Hyskon
4 blood transfusion
23 (24.5%) reported problems (recurrent abnormal bleeding, uterine rupture and pain)
16% further surgery, 84% did not require further surgery at 9 year follow-up
Fertility – 21 became pregnant (2 aborted and 5 TOP; 18 infants delivered)

Endometrial ablation:

0 blood transfusion
22.5% recurrence in increased bleeding
8% had another surgical procedure
91.3% had not required further surgery at 6 year follow-up
Fertility – 0 became pregnant
Mean length of stay – 2.06 nights
Funding source: Not stated

Study summary: hysteroscopic submucous resection of uterine leiomyomas and endometrial ablation appeared to be effective treatment of menorrhagia and leiomyoma over the long term, although effectiveness appears to diminish with time
Fedele 1990473RCT

EL = 1+
n = 24:

GnRH-a (buserelin) prior to myomectomy (n = 8)

Immediate myomectomy (n = 16)
Population characteristics: Women with symptomatic multiple uterine leiomyomas, prevalent symptoms of infertility (n = 18) and menorrhagia (n = 6)

Mean age: 33.6 years (24–38)

Country: Italy
GnRH-a (buserelin) prior to myomectomy or immediate myomectomy Intranasal GnRH-a (buserelin) prior to myomectomy vs immediate myomectomy6 monthsIntra-operative blood loss

post-operative morbidity

short-term myoma recurrence
Intra-operative blood loss (mean):

GnRH-a + myomectomy – 235 ml (SEM 22)
immediate myomectomy −275 ml (SEM 35): NS

Post-operative morbidity (pyrexia ≥ 39 °C):

GnRH-a + myomectomy – 2 women
immediate myomectomy −3 women (NS)

Short-term myoma recurrence:

At 3 months – negative in both groups

At 6 months – Myoma < 1.5 cm recurrence detected by ultrasound:

GnRH-a + myomectomy – 5 (63%)
immediate myomectomy – 2 (13%)

(P < 0.05)
Funding source: not stated

Study summary: A period of induction with hypo-estrogen prior to myomectomy may favour short-term recurrence of myomas, limiting the efficacy of surgery
Fletcher 1996474randomised

EL = 1−
52 randomised; 26 to vasopressin; 26 to tourniquetPopulation characteristics: Women; aged 24 to 45; symptomatic uterine fibroids; uterus size = 10 weeks gestation; excluded if – contraindications to vasopressin.

Baseline characteristics:

Age = 33.2 vs 35.2
Uterus size (weeks) = 16.5 vs 16.6
Number of fibroids = 10.1 vs 9.2
Largest fibroid diameter = 6.6 vs 9.4

Country: Jamaica
Vasopressin; tourniquetNot statedIntra-operative blood loss (ml); Haemoglobin level; postoperative fever;Vasopressin (n = 26) vs tourniquet (n = 26):

Intra-operative blood loss (ml):

287.3 (SD 195) vs 512.7 (SD 200), P = 0.036

Blood loss > 1 litre = 0 vs 6, P = 0.023

Transfusions = 1 vs 5, P = 0.191

Haemoglobin level:

Baseline = 11.9 vs 12.2
Post-operative = 10.2 vs 9.8
(no effect caused by transfusions)

Post-operative fever:

3 vs 5, P = 0.703
Funding source: Not stated
Frederick 1994475Randomised; single blind

EL = 1−
20 randomised (10 to vasopressin; 10 to placebo)Population characteristics: Women; scheduled for myomectomy; symptomatic uterine fibroids; uterine size > 14 weeks.

Baseline characteristics (vasopressin vs placebo):

Age = 32 vs 32
Parity = 0 vs 0
Size of uterus (weeks) = 17 vs 18
Number of fibroids = 14 vs 8
Size of largest fibroid (sm) = 8.6 vs 10

Country: Jamaica
Dilute vasopressin (20 u/ml); saline (20 ml)Not statedBlood loss (ml); Haemoglobin fall (g/dl); haematocrit fall (g/dl)Vasopressin vs placebo:

Blood loss (ml):

225 (150 to 400) vs 675 (500 to 800) (P = 0.0001)

Haemoglobin fall (g/dl):

1.7 vs 5.3 (P = 0.0002)

haematocrit fall (g/dl):

5 vs 13 (P = 0.0003)
Funding source: Not stated
Ginsburg 1993476randomised

EL = 1−
21 women randomised; 10 to vasopressin; 11 to tourniquetPopulation characteristics: Women; symptomatic uterine fibroids; scheduled for myomectomy. Excluded if – prior myomectomy, abdominal adhesions, adnexal masses, or coagulopathy

Baseline characteristics (vasopressin vs tourniquet):

Age = 36 vs 36
Uterine volume (cm3) = 833 vs 650

Country: USA
Vasopressin prior to myomectomy; tourniquet prior to surgeryNot statedTotal blood loss (ml); Operating time (minutes); ; Number of subjects transfused; length of stay (days); hematocrit (%)Vasopressin (n = 10) vs tourniquet (n = 11):

Total blood loss (ml): 461 (SD 177) vs 379 (SD 95)

Operating time (minutes): 72 (SD 6) vs 66 (SD 7)

Number of subjects transfused: 1 vs 3

Length of stay (days): 3.6 vs 4.0

Hematocrit (%):

Pre-operative = 34.0 vs 35.5
Post-operatively = 29.5 vs 29.9

No statistical difference for any comparison.
Funding source: Not stated
Jasonni 2001477randomised

EL = 1−
36 randomised; 20 to long-term GnRH; 16 to short-term GnRHPopulation characteristics: Women; symptomatic uterine fibroids; scheduled for myomectomy.

Country: Italy
GnRH-a for 6 months prior to myomectomy; GnRH-a for 2 months prior to myomectomyNot statedUterine volume (cm3); intra-operative blood loss (ml); LH, FSH and estradiol plasma levelsLong-term vs short-term:

Uterine volume (cm3): 680 (SD 276) vs 745 (SD 320)

Intra-operative blood loss (ml): 315 (SD 93) vs 336 (SD 88)

LH, FSH and stradiol plasma levels: rReduction in both groups, and no differences between groups
Funding source: Not stated
Lethaby 2001469Systematic review; meta-analysis

EL = 1+
26 trials included – 3 waiting to be reviewedPopulation characteristics: Search strategy using keywords and MeSH headings. Hand searching of bibliographies and specific journals.

Search undertaken on MEDLINE, EMBASE, Cochrane library, Current contents, NRR and NLMCTR

Country:
GnRH pre-treatment for hysterectomy or myomectomy in presence of fibroidsUterus size; operative complications62 outcomes are reported. Only most relevant are reported here

GnRH vs placebo pre-treatment for hysterectomy:

Uterine volume (ml) (n = 15, n = 978), WMD = −159.04 [−169.05 to −149.03] in favour of GnRH.
Duration of operation (min): WMD = −5.18 [−8.62 to −1.75] in favour of GnRH.
Proportion undergoing vaginal rather than abdominal hysterectomy: OR = 4.70 [2.97 to 7.45].
Post-operative complications: OR = 0.62 [0.39 to 0.97].
Difficulty with surgery: OR = 0.72 [0.52 to 1.00].
Intra-operative blood loss (ml): WMD = −57.98 [−75.66 to −40.30] in favour of hysterectomy.
No difference between groups for 12 of 16 operative adverse events. Wide confidence intervals for all adverse events.

GnRH vs placebo pre-treatment in myomectomy:

Intra-operative blood loss (ml) (8 studies, n = 263):
WMD = −67.46 [−90.55 to −44.37].
Duration of surgery (min) (5 studies, n = 190):
WMD = 4.20 [−2.69 to 11.08].
Decrease in myomas diameter (1 study, n = 46):
WMD = 19.20 [6.43 to 31.97].
7 of 9 operative adverse events showed no difference between groups. Wide confidence intervals for all adverse event measures.

For most outcomes there was no difference between groups, and all associated with wide confidence intervals.
Funding source: Health Research Council, New Zealand

Study summary: Use of GnRH for 3 to 4 months prior to surgery reduces fibroid size.
Liu 2004460controlled study with no randomisation

EL = 2+
342 women with symptomatic fibroidsPopulation characteristics: Mean age: 39 years (24 to 49)

Country: Taiwan
Myomectomy only (n = 108) (Group 1)

Combined uterine depletion and myomectomy (n = 234) – (Group 2)

Combined uterine depletion and myomectomy vs myomectomy only
25.4 months (14–52)Operation time

Intra-operative blood loss

Post-op symptoms improvement

Fibroid recurrence
Symptoms resolution

Menorrhagia:

Group 1: 79/94 (84%)
Group 2: 194/194 (100%)

Dysmenorrhoea:

Group 1: 31/36 (86%)
Group 2: 104/106 (98%)

Compression:

Group 1: 16/16 (100%)
Group 2: 37/37 (100%)

Total:

Group 1: 88/108 (82%):
Group 2: 232/234 (99%)

Operation time:

Group 1: 55 min (40–85)
Group 2: 68 min (48–115)

Intra-operative mean blood loss:

Group 1: 250 ± 133 ml (30–850)
Group 2: 50 ± 27 ml (20–350) (P < 0.001)

Post-op hospital stay:

Group 1: 3.4 ± 0.9 days
Group 2: 3.2 ± 1.0 days

Fibroid recurrence:

Group 1: 21 (19%) recurrence at 16 month follow-up, 5 (24%) underwent second myomectomy
Group 2: 0% (P < 0.001)
Funding source: Not stated

Study summary: The procedure of uterine depletion before myomectomy (for the management of uterine), reduces intra-operative blood loss, resulted in complete resolution of fibroid-related menorrhagia and has the potential to prevent fibroid recurrence.
Loffer 2005458Comparative study

EL = 2+
177 women

Hysteroscopic myomectomy without endometrial ablation (EA) (n = 104)

Hysteroscopic myomectomy with concomitant endometrial ablation (n = 73)
Population characteristics: Indications:

menorrhagia and menometrorrhagia

Women with EA: Mean age 44 years, 80% had endometrial pre-treatment

Women without EA: Mean age 37.6 years, 26% had endometrial pre-treatment

Country: USA
Hysteroscopic myomectomy without endometrial ablation (EA)

Hysteroscopic myomectomy without endometrial ablation (EA) vs) Hysteroscopic myomectomy with concomitant endometrial ablation
up to 15 yearsControl of bleeding

No of subsequent hysterectomy
Control of bleeding:

Women with EA:

96% bleeding was controlled at up to 15 years

Women without EA:

81% bleeding was controlled at up to 15 years

(OR 0.18, 95% CI 0.05 to 0.63)

In women who had complete removal of myoma:

bleeding was controlled in 90%

In women who had incomplete removal of myoma: bleeding was controlled in 76%

(OR 0.39, 95% CI 0.16 to 0.99)

In women who had complete removal of myoma and EA: bleeding was controlled in 97%

In women who had complete removal of myoma and no EA: bleeding was controlled in 84%

(OR 0.19, 95% CI 0.04 to 0.87)

In women who had incomplete removal of myoma and EA: bleeding was controlled in 92%

In women who had incomplete removal of myoma and no EA: bleeding was controlled in 70%

(OR 0.20, 95% CI 0.02 to 1.79) (NS)

Myoma completely removed + EA vs myoma not completely removed + EA: significant success in control of bleeding (common OR 5.25, 95% CI 1.49 to 18.5)

Subsequent hysterectomy:

In women with EA: 18%
In women with no EA: 22% (NS)
In women with complete resection: 18%
In women with incomplete resection: 30% (NS)
Complete myoma removal + EA: 18%
Complete myoma removal with no EA: 17% (NS)
Incomplete myoma removal + EA: 15%
Incomplete myoma removal with no EA: 37% (NS)
Funding source: Not stated

Study summary: Endometrial ablation at the time of hysteroscopic myomectomy improves results in the control of bleeding
Palomba 2002478randomised; open

EL = 1−
66 randomised; 22 to GnRH, iron and tibolone group; 22 to GnRH and iron and placebo; 22 to iron only. 5 women dropped out of study, but no information on from which groups.Population characteristics: Women; pre-menopausal; symptomatic uterine fibroids; largest fibroid between 400 and 500 cm3; maximum of 3 fibroids. Excluded if – systemic disease or malignancy, pregnant, submucosal fibroids

Baseline (tibolone vs GnRH vs iron only):

Age = 24.9 vs 27 vs 26.6
Parity = 1.1 vs 1.0 vs 1.0
BMI = 23.6 vs 24.4 vs 24.2

Country: Italy
GnRH, Iron tablets, and tibolone; GnRH, iron tablets and placebo; iron tablets only. All prior to surgery.3 monthsHot flushes (pre-surgery); Uterine volume (cm3); fibroid volume (cm3); fibroid symptoms; duration of surgery (minutes)Tibolone vs GnRH vs Iron only:

Hot flushes (pre-surgery):

Tibolone group significantly less than placebo group (P < 0.05). (Data presented on weekly basis so not summarised.)

Uterine volume (cm3):

Basline = 528 (SD 83) vs 504 (SD 92) vs 496 (SD 99).
1 week prior to surgery = 373 (SD 51) vs 337 (SD 50) vs 498 (SD 97).
1 week post-surgery = 198 (SD 27) vs 193 (SD 18) vs 201 (SD 19).

Reduction in volume significant for tibolone and GnRH groups, and no difference between groups

Fibroid volume (cm3);

Baseline = 179 (SD 48) vs 167 (SD 41) vs 163 (SD 38).

1 week prior to surgery = 130 (SD 31) vs 113 (SD 23) vs 164 (SD 39).

Reduction in volume significant for tibolone and GnRH groups, and no difference between groups.

Fibroid symptoms (10 cm VAS):

Menorrhagia:

Baseline = 6.8 vs 7.1 vs 6.8
1 week prior to surgery = 3.5 vs 1.8 vs 7.4
(Not measured post-operatively)

Duration of surgery (minutes): 99.8 (SD 22.7) vs 91.5 (SD 17.6) vs 117.3 (SD 16.1)

Intra-operative blood loss (ml): 186.8 (SD 62.2) vs 171.2 (SD 64.3) vs 245.8 (SD 53.0), P < 0.05 for iron vs other groups.
Funding source: Not stated
Phillips 1995575Case series; prospective

EL = 2+
208 (120 with transcervical electrosurgical resection, and 88 with additional transcervical endometrial resection)Population characteristics: TSR – Women; uterine fibroids; menorrhagia – subjective; desire to preserve fertility

TEMR (as above) but no desire for fertility; poor surgical risk; refused hysterectomy; post-menopausal bleeding.

Demographic information (TSR vs TSR-TEMR)

Mean age (years) = 37.9, 43.2
Mean leiomyoma diameter (cm3) = 2.6, 3.2
Mean uterine size (gestational weeks) = 7.2, 6.8

Country: USA
transcervical electrosurgical resection; transcervical endometrial resection; GnRH pre-treatment for women with > 50% of cavity occupied by fibroid.Up to 6 yearsOperative time; length of stay; Complications; menstrual bleeding patterns; Additional surgeryOperative time (TSR vs TSR-TEMR, minutes) = 30.2 vs 39.5

Mean length of stay (TSR vs TSR-TEMR, hours) = 4.3 vs 4.7

Complications (TSR vs TSR-TEMR) = 5 vs 3

Mean fluid absorbed (TSR vs TSR-TEMR, ml) = 578 vs 677 (P < 0.05)

Bleeding patterns at 6 months (TSR vs TSR-TEMR):

Amenorrhoea = 0 vs 62
Hypomenorrhoea = 0 vs 16
Eumenorrhoea = 113 vs 7
Unsatisfactory = 7 vs 3
Satisfactory = 113 (94.2%) vs 85 (96.6%)

Additional surgery by 6 months (TSR vs TSR-TEMR) = 8 vs 6

Bleeding patterns by 6 years follow-up (TSR vs TSR-TEMR):

Amenorrhoea = 8 vs 49
Hypomenorrhoea = 0 vs 11
Eumenorrhoea = 82 vs 9
Unsatisfactory = 16 vs 9
Satisfactory = 90 (84.1%) vs 69 (88.5%)
Funding source: Not stated

Study summary: TSR with or without TEMR is an effective and safe treatment for women with submucous leiomyomas suffering from chronic menorrhagia.
Razavi 2003424Comparative cohort study

EL = 2+
111 women undergoing abdominal myomectomy (AM) (n = 44) or uterine fibroid embolisation (UTE) (n = 67) for symptomatic uterine fibroidsPopulation characteristics: Mean age:

AM – 37.7 years; UTE – 44.2 years

Country: USA
abdominal myomectomy or uterine fibroid embolisation

abdominal myomectomy or uterine fibroid embolisation
AM: 14.6 months

UTE: 14.3 months
Success rate: significant reduction of menorrhagia and pain

Complications

hospital stay

use of narcotics

resumption of normal activities
Significant reduction in menorrhagia:

AM: 64%
UTE: 92% (P < 0.05)

Significant reduction in pain:

AM: 74%
UTE: 52% (NS)

Significant reduction in mass effect:

AM: 91%
UTE: 76% (P < 0.05)

Complications:

AM: 10 (25%) (3 blood transfusion, mean blood loss 376 ml, 2 wound infection, 2 adhesion, 1 readmission for ileus, 1 chronic pelvic pain, 1 incisional pain).
UTE: 7 (11%) (P < 0.05) (Minimal blood loss, 1 endometritis, 1 pelvic pain, 1 groin numbness, 4 menopause.

Mean hospital stay:

AM: 2.9 days
UTE: 0 day (P < 0.05)

Mean days taking pain medications:

AM: 8.7
UTE: 5.1 (P < 0.05)

Mean days till normal activity:

AM: 36
UTE: 8 (P < 0.05)

Secondary intervention:

AM: 10%
UTE: 8% (NS)
Funding source: not stated

Study summary: UTE is less invasive and safer treatment than AM in women with symptomatic fibroids
Sapmaz 2003576Randomised

EL = 1−
51 randomised; 26 in bilateral ligation; 25 in tourniquetPopulation characteristics: Women; symptomatic uterine fibroids; scheduled for myomectomy

Baseline (ligation vs tourniquet):

Age = 32 vs 33
Parity = 1.1 vs 1.3
Menorrhagia = 12 vs 12
Pelvic pain = 9 vs 10
Pollaciuria = 4 vs 3
Infertility = 0 vs 0
Number of myoma = 5.5 vs 5.5
Maximum myoma volume = 205 vs 207

Country: Turkey
bilateral ligation prior to myomectomy; tourniquet prior to myomectomy6 monthsIntra-operative blood loss (ml); duration of operation (min); Haemoglobin levels (g/dl)Ligation (n = 26) vs tourniquet (n = 25):

Intra-operative blood loss (ml): 220 (SD 50) vs 294 (SD 60)

Duration of operation (min): 67 vs 68

Haemoglobin levels (g/dl):

Baseline = 12 vs 12
After myomectomy = 11.4 vs 10.9)P < 0.05)
At 24 hours = 11.3 vs 10.8 (P < 0.05)

No blood transfusion in either group.
Funding source: Not stated
Taylor 2005577Randomised – computer generated; opaque envelopes; single blind;

EL = 1+
171 eligible; 28 randomised; 14 to control group; 14 to tourniquet group.Population characteristics: Women; symptomatic fibroids; ≥ 14 week gestation; requesting myomectomy; excluded if – history of bleeding disorder, concurrent anticoagulant therapy, or haemoglobin < 10.5 g/dl

Baseline characteristics (control vs tourniquet):

Age = 39.5 vs 42.6
Parity = 0 vs 0
Hb (g/dl) = 11.8 vs 12.2
GnRH-a = 1 vs 2
Previous surgery = 2 vs 3
Uterine size (weeks) = 18 vs 17

Country: UK
Tourniquet; no treatment6 monthsBlood loss;

transfusion rates;

complication rates
Control (n = 14) vs tourniquet (n = 14):

Operative details:

Operating time (min) = 118 vs 114
Tourniquet time = – vs 52
Number of fibroids removed = 4.5 vs 10.5
Weight of fibroids = 481 vs 395
Blood loss (ml) = 2359 vs 489 (P = 0.0001)

Post-operative blood loss:

Drained in 48 hours = 220 vs 150 (P = 0.165)
Transfusion = 59 vs 2 (P = 0.0005)
Patients transfused = 11 vs 1 (P = 0.0003)

Episodes of post-operative morbidity: 8 vs 1 (P −0.0128)
Funding source: Not stated
Vercellini 2003479randomised – computer generated concealed– opaque envelopes

EL = 1+
162 eligible; 100 randomised; 50 to GnRH (49 completed); 50 to immediate surgery (48 completed).Population characteristics: Women; pre-menopausal; 18 to 40 years old; symptomatic uterine fibroids – intramural or subserous; excluded if – previous surgery for fibroids, uterine malformations, past pelvic inflammatory disease, coagulation disorders, or unstable general condition, haemoglobin < 10 g/dl.

Baseline characteristics (GnRH vs immediate surgery):

Age = 34 vs 33
BMI = 22 vs 23
Uterine volume (weeks) = 12 vs 12
Uterine volume (ml) = 343 vs 338
Diameter of largest fibroid = 69 vs 66

Country: Italy
GnRH-a for 2 months prior to myomectomy; myomectomy6 monthsIntra-operative blood loss (ml); Operating time (minutes); difficulty of surgeryUterine volume decreased tp 269 (SD 119) in the GnRH- a group, immediate group not assessed.

GnRH vs Immediate surgery:

Intra-operative blood loss (ml): 265 (SD 181) vs 296 (SD 204)

Operating time (minutes): 93 (SD 32) vs 90 (SD 32)

Difficulty of surgery:

Easier = 3 vs 2
Same = 38 vs 39
Difficult = 8 vs 7

No statistical difference between groups.

No difference between groups based on size of uterus, number of fibroids removed or length of incisions.
Funding source: Not stated
Zullo 2004480randomised

EL = 1−
60 randomised; 30 therapy (28 assessed); 30 to placebo (28 assessed)Population characteristics: Women; pre-menopausal; symptomatic uterine fibroids; excluded if – systemic disease, malignancy, fibroids not between 3 to 5 cm, calcification or hypoechoic fibroids, pregnant

Country: Italy
Bupivacaine plus epinephrine; placebo2 daysIntra-operative blood loss (ml); duration of surgery; vials of analgesia used (n)Therapy vs placebo:

Intra-operative blood loss (ml): 143.9 (SD 48.1) vs 212.5 (SD 51.), P < 0.001

Duration of surgery: 78.7 (SD 13.1) vs 109.2 (SD 15.2), P < 0.001

Vials of analgesia used (n): 4 vs 7.6, P < 0.01
Funding source: Not stated
Sawin 2000457Comparative cohort study

EL = 2+
394 women

Abdominal myomectomy (AM): n = 197

Abdominal hysterectomy (AH): n = 197
Population characteristics: Mean age

AM: 36 years
AH: 44 years (P < 0.0001)

Mean weight

AM: 156 lbs
AH: 174 lbs (P < 0.0001)

Mean parity:

AM: 0.5
AH: 1.6 (P < 0.0001)

Pre-op uterus size (weeks equivalent)
AM:14
AH: 16 (P < 0.0001)

Indications:

AM: vaginal bleeding (37%) or pain (39%), recurrent miscarriage, infertility
AH: vaginal bleeding (62%) or pain (31%)

Country: USA
AM vs AH

AM vs AH
Chart review over a period of 2 yearsMorbidity

Post op care
Morbidity:

Overall morbidity:
AM: 39%; AH: 40% (OR 0.93, 95% CI 0.63 to 1.40)

Febrile morbidity: AM: 33%; AH: 26% (OR 1.41, 95% CI 0.91 to 2.17)

Haemorrhage: AM: 10%; AH: 14% (OR 0.46, 95% CI 0.26 to 0.83)

Unintended procedure: AM: 4.5%; AH: 0.6% (OR 0.45, 95% CI 0.20 to 0.99)

Life threatening event: AM: 1.5%; AH: 1% (OR 1.51, 95% CI 0.17 to 18.00)

Readmission: AM: 1.5%; AH: 2.5% (OR 0.59, 95% CI 0.09 to 3.10)

Post-op care:

Mean operative time (min): AM: 201; AH: 176 (P < 0.00002)

Estimated blood loss (ml): AM: 227; AH: 484 (P < 0.00001)

Length of hospital stay (days): AM: 4; AH: 4.4 (P < 0.048)

Max drop in Hgb: AM: 2.5; AH: 4 (NS)

Transfusion (no.): AM: 9%; AH: 13% (NS)
Funding source: Not stated

Study summary: No clinical difference in peri-operative morbidity between myomectomy and hysterectomy. Myomectomy should be considered a safe alternative to hysterectomy
Gupta 2005416Systematic review; meta-analysis

EL = 1+
3 RCTs included.Population characteristics: Searched the Cochrane Menstrual Disorders and Subfertility Group Trials register (searched 10 August 2005 the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library, Issue 3, 2004), MEDLINE (January 1966 to November 2005) and EMBASE (January 1980 to November 2005). Contacted authors of potential ongoing studies.

Country: UK
Uterine artery embolisation)N/ADuration of operation (min); length of stay (days); length of recovery (days); ComplicationsOutcomes for UAE vs hysterectomy (outcome title; number of studies; number of participants statistical method; effect size):

Duration of procedure (min): 1, 156, WMD (fixed) −16.40 [95% CI −26.04 to −6.76].
Intra-procedure blood loss (ml): 1, 156, WMD (fixed) −405.20 [95% CI −512.71 to −297.69].
Intra-procedural complications: 2, 216, OR (fixed) 2.02 [95% CI 0.74 to 5.47].
Need for blood transfusion: 2, 216, OR (fixed) 0.04 [95% CI 0.00 to 0.33].
Length of hospital stay (days): 2, 213, WMD (fixed) −3.27 [95% CI −3.77 to −2.77].
Unscheduled visits after discharge: 2, 217, OR (fixed) 1.80 [95% CI 0.98 to 3.30].
Readmission rates within 42 days: 2, 216, OR (fixed) 6.00 [95% CI 1.14 to 31.53]

Resumption to normal activities: 1, 59, WMD (fixed) −26.68 [95% CI −36.15 to −17.21].
Satisfaction with treatment: 1, 53, OR (fixed) 0.47 [95% CI 0.09 to 2.48]

UAE vs myomectomy (Outcome title; number of studies; number of participants; Statistical method; Effect size)@

Duration of procedure (minutes): 1, 63, WMD (fixed)−34.50 [95% CI −48.74 to −20.26].
Febrile morbidity: 1, 63, OR (fixed) 0.90 [95% CI 0.24 to 3.32].
Need for antibiotics: 1, 63, OR (fixed) 1.12 [95% CI 0.25 to 4.92].
Need for blood transfusion: 1, 63, OR (fixed) 0.21 [95% CI 0.01 to 4.48].
Length of hospital stay (days): 1, 63, WMD (fixed) −1.60 [95% CI −2.47 to −0.73].
Hospital stay 1 week: 1, 63, OR (fixed) 0.11 [95% CI 0.01 to 2.08].
Readmission to hospital: 1, 63, OR (fixed) 2.29 [95% CI 0.20 to 26.58].
Duration to full recovery (days): 1, 63, WMD (fixed)−16.40 [95% CI −21.16 to −11.64].
Relief of fibroid-related symptoms at 6 months follow-up: 1 54 OR (fixed) 0.50 [95% CI 0.08 to 3.27].
Total relief of all fibroid-related symptoms at 6 months follow-up: 1, 54, OR (fixed) 0.36 [95% CI 0.12 to 1.11].
Fibroid-related symptoms same or worse at 6 months follow-up: 1 54 OR (fixed) 2.00 [95% CI 0.31 to 13.06].
Serum FSH levels at 6 months follow-up: 1, 63, WMD (fixed) 0.79 [95% CI −0.24 to 1.82].
FSH levels 20 iu/l: 1, 63, OR (fixed) 8.53 [95% CI 0.42 to 172.28].
Fibroids detected by USS 4 cm by at least 6 months follow-up: 1, 63, OR (fixed) 5.88 [95% CI 1.88 to 18.44].
Re-intervention rate: 1, 63, OR (fixed) 8.97 [95% CI 1.79 to 44.95].
Funding source: No financial support

Study summary: UAE offers an advantage over hysterectomy with regards to a shorter hospital stay and a quicker return to routine activities. There is no evidence of benefit of UAE compared with surgery (hysterectomy / myomectomy) for satisfaction. The higher minor complications rate after discharge in the UAE group as well as the unscheduled visits and readmission rates require more longer term follow-up trials to comment on its effectiveness and safety profile. There is currently an ongoing trial (REST, U. K.) and EMMY trial yet to report on the long term follow up, the results of which are awaited with interest.
Seracchioli,R 2000461RCT

EL = 1−
131It reported a significantly higher incidence of febrile morbidity (> 38 °C) in the abdominal group than in the laparoscopic group (26.2% vs 12.1%; P < 0.05). The mean drop in haemoglobin was more pronounced in the abdominal group (2.17 ± 1.57 vs 1.33 ± 1.23; P < 0.001).

From: Evidence Tables

Cover of Heavy Menstrual Bleeding
Heavy Menstrual Bleeding.
NICE Clinical Guidelines, No. 44.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2007 Jan.
Copyright © 2007, National Collaborating Centre for Women's and Children's Health.

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