Laparoscopic-assisted vaginal hysterectomy versus minilaparotomy hysterectomy: A prospective, randomized, multicenter study
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Volume 13, Issue 2, Pages 114120 (April 2006)
Laparoscopicassisted vaginal hysterectomy versus total laparoscopic hysterectomy for the management of endometrial cancer: A randomized clinical trial Fabio Ghezzi, MDa , Antonella Cromi, MDa, Valentino Bergamini, MDb, Stefano Uccella, MDa, Paolo Beretta, MDa, Massimo Franchi, MDb, Pierfrancesco Bolis, MDa Bottom of Form Received 24 September 2005; accepted 20 November 2005 Abstract Study objective To compare laparoscopicassisted vaginal hysterectomy (LAVH) and total laparoscopic hysterectomy (TLH) for the treatment of endometrial cancer. Design Randomized, controlled trial. Design classification Randomized controlled trial (Canadian Task Force classification I). Setting Two gynecologic oncologic units of university hospitals. Patients Seventytwo women with endometrial cancer randomized to undergo either LAVH or TLH. Interventions Total laparoscopic hysterectomy or laparoscopicassisted vaginal hysterectomy, bilateral salpingooophorectomy, peritoneal washing, and systematic pelvic lymphadenectomy. Measurements and main results Parameters of technical feasibility (operating time of hysterectomy phase, estimated blood loss, perioperative complications) were considered as major statistical endpoints. Thirtyseven women were allocated to the LAVH arm, and 35 were allocated to the TLH arm. Mean total operating time was significantly shorter in the TLH than in the LAVH group (184.0 ± 46.0 vs 213.2 ± 39.4 minutes, p = .003). The hysterectomy phase was longer in the LAVH than in the TLH group only in overweight (77.9 ± 9.8 vs 68.1 ± 9.3 min, p = .005) and obese patients (87.7± 13.1 vs. 62.1± 9.9 min, p I, highrisk histologic condition (nonendometrioid endometrial cancer), and lymphvascular invasion. Patients with serous histologic conditions and extrauterine disease received postoperative chemotherapy with or without radiotherapy. Followup visits were scheduled monthly for the first 3 months, then every 3 months for the first 2 years, and every 6 months thereafter. Statistical analysis Statistical analysis was performed with GraphPad Prism version 3.00 for Windows (GraphPad Software, San Diego, CA) and with Epistat 4.0 (Epistat Services, Richardson, TX). Normality testing (KolmogorovSmirnov test) was performed to determine whether data were sampled from a Gaussian distribution. The t test and the Mann Whitney U test were used to compare continuous parametric and nonparametric variables, respectively. Proportions were compared using the Fisher exact test. Comparisons of 3 or more groups (continuous variables) was performed with analysis of variance. The Bonferroni test was used for posthoc analysis. Parameters of technical feasibility were considered as the major statistical endpoints. Previous studies on benign disease suggested that TLH was associated with lower operative time and estimated blood loss compared with LAVH. Data from 50 consecutive patients who underwent LAVH in our departments before the initiation of this study (unpublished data) showed a mean ± SD operating time of 90 ± 25 minutes and a mean ± SD estimated blood loss of 145 ± 115 mL. Given the limited clinical relevance of such an amount of blood loss, sample size analysis was
performed using operative time as primary outcome measure. With a type I error of 0.05 and a power of 80%, a total of 32 patients in each arm were required to demonstrate a 20% difference in the duration of surgery. Results During the study period, a total of 81 patients were referred to our departments for the surgical treatment of endometrial cancer. Of these, eight (9.9%) were not eligible for randomization because of a large uterus (n = 1), age over 75 (n = 5), and history of heart failure or pulmonary obstructive disease contraindicating prolonged Trendelenburg position (n = 2). In one patient the laparoscopic procedure was converted to laparotomy before randomization to control a significant hemorrhage caused by a laceration of the external iliac vein during the lymphadenectomy phase. Seventytwo patients entered the study; 37 were randomized to undergo LAVH and 35 to undergo TLH. The patients’ characteristics did not differ significantly between groups (Table 1). Tumor stage and histologic type are displayed in Table 2. Table 1. Patient characteristics
Characteristics
LAVH group (n = 37) TLH group (n = 35) p Value
Age (yrs)
63 ± 8.9
63.5 ± 8.8
.55
BMI (kg/m2)
27.9 ± 5.4
26.9 ± 5.4
.22
Nulliparae
7(18.9%)
9(25.7%)
.57
Previous abdominal surgery
13(35.1%)
11(31.4%)
.80
Normal weight
16(43.2%)
10(28.6%)
.22
Overweight
11(29.7%)
18(51.4%)
.09
Obese
10(27.0%)
7(20.0%)
.58
LAVH = laparoscopicassisted vaginal hysterectomy; TLH = total laparoscopic hysterectomy. Values are reported as mean ± standard deviation or number (%)
Table 2. Pathologic findings and FIGO stage
LAVH group (n = 37)
TLH group (n = 35)
p Value
Histology Endometrioid
34(91.9%)
30(85.7%)
.47
Serous
2(5.4%)
5(14.3%)
.25
Squamous
1(2.7%)
0
1.0
1
11(29.7%)
11(31.4%)
1.0
2
20(54.0%)
19(54.3%)
1.0
3
6(16.2%)
5(14.3%)
1.0
Ia
5(13.5%)
4(11.4%)
1.0
Ib
23(66.1%)
16(45.7%)
.24
Ic
3(8.1%)
3(8.6%)
1.0
IIa
0
3(8.6%)
.11
IIb
1(2.7%)
0
1.0
Grade
Stage
LAVH group (n = 37)
TLH group (n = 35)
p Value
IIIa
1(2.7%)
6(17.1%)
.05
IIIb
0
0
—
IIIc
4(10.8%)
3(8.6%)
1.0
LAVH = laparoscopicassisted vaginal hysterectomy; TLH = total laparoscopic hysterectomy. Values are reported as numbers (%). Both groups were similar in the incidence of intraoperative and postoperative complications ( Table 3). Intraoperative complications occurred in four patients, three (8.1%) in the LAVH group and one (2.8%) in the TLH group. One patient in the LAVH group had a bladder injury during uterovesical fold incision, which was sutured laparoscopically. Moderate subcutaneous emphysema occurred at pneumoperitoneum creation in one woman in the LAVH group; this complication was managed by waiting 60 minutes before continuing the operation. One patient displayed soon after surgery an upper medial tight pain exacerbated by abduction and associated with a gait disturbance that was attributable to an intraoperative injury of the obturator nerve. This patient recovered with complete resolution of the disturbance with physiotherapy within 2 months. In the TLH group 1 patient had moderate bleeding from the right port entry, which was managed by a transparietal suture. Table 3. Intra and postoperative details
LAVH group (N = TLH group (N = p 37) 35)
Estimated blood loss (total)
150(50–450)
100(50– 500)
=0.13
Estimated blood loss (hysterectomy phase)
100(50–300)
100(50– 400)
=0.06
Lymph nodes yield
18(7–31)
20(15–39)
=0.08
LAVH group (N = TLH group (N = p 37) 35)
Patients with intraoperative complications
3(8.1%)
1(2.8%)
=0.61
Bladder
1(2.7%)
0
=1.0
Ureter
0
0
—
Bowel
0
0
—
Vascular
0
0
—
Nerve
1(2.7%)
0
=1.0
Wound
0
1(2.8%)
=1.0
Intraabdominal
0
0
—
Vaginal
0
0
—
Subcutaneous emphysema
1(2.7%)
0
=1.0
Blood transfusions
0
0
—
Conversion to laparotomy
0
0
—
Patients with postoperative
7(18.9%)
5(14.3%)
=0.75
Organ injury
Hemorrhage
LAVH group (N = TLH group (N = p 37) 35)
complications Urinary infection
1(2.7%)‡
2(5.7%)
=0.61
Febrile morbidity
3(8.1%)†
2(5.7%)
=1.0
Sepsis
0
1(2.7%)
=0.48
Lymphedema
2(5.4%)
1(2.7%)
=1.0
Seroma
1(2.7%)†
0
=1.0
Wound infection
1(2.7%)
0
=1.0
Subfascial hematoma
1(2.7%)‡
0
=1.0
LAVH = laparoscopicassisted vaginal hysterectomy; TLH, total laparoscopic hysterectomy. Values are reported as median (range) or number (%). complications occurred to the same patient. † complications occurred to the same patient. ‡ complications occurred to the same patient. A total of 12 (19.7%) patients had development of postoperative complications, with three women experiencing multiple complications. In the LAVH group, the postoperative course of one patient was complicated by both a subfascial hematoma, which was managed conservatively, and urinary tract infection; another patient, who had postoperative fever, 6 months after surgery had an asymptomatic 10cm large seroma. One woman who underwent TLH experienced febrile morbidity and subsequently had development of lymphedema of one leg. In the TLH group one patient was readmitted with fever and chills on postoperative day 10, and blood cultures revealed anaerobic sepsis caused by Bacteroides species. No source of
infection, such as an abscess, was detected. The patient fully recovered after prolonged antibiotic treatment with intravenous clindamycin and metronidazole. The median (range) postoperative hospital stay was similar in the LAVH group (3 days [16 days] days) and in the TLH group (2 days [19 days] days) (p = .30). Table 4 displays operating times of the study population stratified by BMI categories. No significant variation by BMI was observed in the duration of surgery within the TLH group. In the LAVH group, overweight and obese patients had a significantly longer operating time compared with women of ideal BMI. There was no difference in the proportion of nulliparous women who underwent LAVH among idealweight patients (2/6 [33.3%]), overweight patients (3/11 [27.3%]), and obese patients (2/10 [20%]), (p = .2). Table 4. Operating time stratified by BMI categories
LAVH group (n = 37) TLH group (n = 35) p
Total study population Total operative time (min)
213.2±39.4
184.0±46.0
.003
Hysterectomy phase
79.5±12.4
66.4±11.4
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