The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic
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《英国医生杂志》
1 University of Western Australia, Department of Obstetrics and Gynaecology, King Edward Memorial Hospital, Subiaco, Perth, WA 6008, Australia, 2 Northern and Yorkshire Clinical Trials and Research Unit, University of Leeds, Leeds LS2 9NG, 3 James Cook University Hospital, Middlesbrough TS4 3BW, 4 Royal Women's Hospital, University of New South Wales, Randwick NSW 2031, Australia, 5 St James's University Hospital, Leeds LS9 7TF, 6 Department Public Health and Epidemiology, University of Birmingham, Birmingham B15 2UP, 7 Director of Public Health, Newcastle under Lyme, Primary Care Trust, Newcastle-under-Lyme, Stafforshire ST5 7NJ
Correspondence to: R Garry rgarry@obsgyn.uwa.edu.au
Abstract
In 1996 Stovall and Summitt concluded that well designed clinical trials examining short term outcomes, economics, and quality of life were required to determine the role of laparoscopic hysterectomy.1 Ten previous randomised trials have compared outcomes for abdominal hysterectomy with laparoscopic hysterectomy.2-11 Most of these were from single centres of endoscopic surgical excellence and had small study populations. Each trial showed that laparoscopic hysterectomy was associated with reduced hospital stay and, in most studies, a shorter time to convalescence and notably less pain than abdominal hysterectomy.
Oonly four previously published randomised trials have compared the outcomes of vaginal hysterectomy and laparoscopic hysterectomy.12-15 The only difference shown in these studies was that laparoscopic hysterectomy took longer to perform.
We know of no previous trials that were powered to investigate the safety of the various procedures. We have therefore undertaken a concurrent pair of randomised controlled trials to eVALuate the relative roles of Vaginal, Abdominal, and Laparoscopic hysterectomy in routine gynaecological practice.
Methods
Forty three gynaecologists from 28 UK and two South African centres recruited 876 patients into the abdominal trial and 504 into the vaginal trial between November 1996 and September 2000. The recruitment target in the abdominal trial was therefore not reached. The trial steering committee closed the trials in September 2000 because funding ended and the rate of recruitment decreased.
Demography
Baseline characteristics were well matched in each of the allocated trials (table 1). The baseline characteristics between the two trials differed. More than 90% of the patients allocated to the vaginal trial had had one or more vaginal deliveries compared with less than 85% in the abdominal trial. This distribution was reversed for caesarean deliveries. Only one of 30 patients with palpable endometriosis was allocated to the vaginal trial. Patients with pelvic pain, more than one indication for hysterectomy, a fixed uterus, no uterine descent, or intended removal of the ovaries were more likely to be allocated to the abdominal trial.
Table 1 Baseline characteristics of participants in the two trials. Values are numbers (percentages) of participants unless otherwise indicated
The mean waiting times for the operations were similar, about 70 days. The main indications for hysterectomy were dysfunctional uterine bleeding (874/1380 cases, 63%), fibroids (235 cases, 17%), pelvic pain (151 cases, 11%), endometriosis (126 cases, 9%), and failed ablation (104 cases, 8%).
Numbers analysed
The figure shows the flow of patients through the trials. We performed a per protocol analysis as 46 (3.3%) patients were allocated to one procedure but had an alternative operation because of preoperative conversion (patient's decision (25 cases, 54%) and surgeon's unavailability (10 cases, 22%)). We undertook sensitivity analyses for the 34 patients who did not actually have an operation. Reasons for withdrawing preoperatively were mainly cancelled operations (25 cases, 74%).
Flow of participants through the trials. Among patients whose procedures were converted, 283 underwent abdominal hysterectomies and 576 laparoscopic hysterectomies in the abdominal trial; 173 underwent vaginal hysterectomies and 314 laparoscopic hysterectomies in the vaginal trial. Follow up forms not received within the appropriate time frames were not included in the analysis. The time frames were 14 days at six weeks and 28 days at four months and one year
Primary outcome
Table 2 details the major complications. Patients had up to four major complications. Of particular importance in the abdominal trial were severe haemorrhage following laparoscopic hysterectomy (4.6%) and abdominal hysterectomy (2.4%), as well as ureteric injuries in both trials. All six of the damaged ureters occurred in the laparoscopic hysterectomy arms. Unintended laparotomy was the second most common complication, affecting 45 patients; of these 13 had another major complication. The reasons given for the other conversions included additional pathology, poor access, removal of ovarian cyst, unable to secure haemostasis, and endometrial cancer.
Table 2 Primary end point of both trials: major complications. Values are numbers (percentages) of participants
In the abdominal trial significantly more patients undergoing laparoscopic hysterectomy than patients undergoing abdominal hysterectomy had at least one major complication (11.1% v 6.2%, mean difference 4.9%, 95% confidence interval 0.9% to 9.1%; odds ratio 1.91, 1.11 to 3.28). The number needed to treat to harm was 20. In this trial the odds of having a major complication was approximately twice as likely for patients undergoing laparoscopic hysterectomy.
We found no difference in the complication rates after the two procedures in the vaginal trial (9.8% for laparoscopic hysterectomy, 9.5% for vaginal hysterectomy (n = 18), mean difference 0.3%, -5.2% to 5.8%, P = 0.92; odds ratio 0.97, 0.52 to 1.81); the number needed to treat to harm was 333. However, this trial was not powered to detect a difference.
Per protocol and sensitivity analyses narrowed the size of difference between the types of operation for both trials, but the difference remained in the same direction. Adjustment for stratification factors made little difference to treatment effects.
Secondary outcomes
Minor complications—In the abdominal trial the percentage of patients who had at least one minor complication was 27.1% in patients undergoing abdominal hysterectomy compared with 25.2% for laparoscopic hysterectomy, and in the vaginal trial 27.9% for patients undergoing vaginal hysterectomy and 23.2% for laparoscopic hysterectomy (table 3). We found no evidence to show that there was any difference in minor complication rates between the procedures (P > 0.05) in any of the comparisons (intention to treat and sensitivity).
Table 3 Secondary end points of both trials: minor complications. Values are numbers (percentages) of patients
Additional pathology found during the operation—In the abdominal trial additional pathology was reported in 12.7% (373/292) of patients undergoing abdominal hysterectomy compared with 22.6% (132/584) undergoing laparoscopic hysterectomy (mean difference -9.9%, -15.4 to -4.4%, P = < 0.01). In the vaginal trial the rates were 4.8% (8/168) for vaginal hysterectomy and 16.4% (53/336) for laparoscopic hysterectomy (mean difference -11.6%, -17.7% to -5.5%, P = < 0.01). The main additional findings were adhesions, endometriosis, and fibroids.
Pain—In the abdominal trial abdominal hysterectomy was more painful than laparoscopic hysterectomy (adjusted mean pain score 3.9 abdominal hysterectomy, 3.5 laparoscopic hysterectomy; mean difference 0.4, 0.09 to 0.7, P = 0.01). A slightly higher proportion of patients undergoing abdominal hysterectomy used opiates than patients undergoing laparoscopic hysterectomy (80% v 76%). We found no evidence of a difference in pain scores in the vaginal trial. In this trial a higher proportion of patients undergoing vaginal hysterectomy (71%, 119/168) used opiates than patients undergoing laparoscopic hysterectomy (62%, 209/336).
Length of surgery and length of stay—Table 4 summarises the data for length of procedure. In the abdominal trial the median (minimum, maximum) length of stay after abdominal hysterectomy was four (1, 36) days and three (1, 36) days after laparoscopic hysterectomy, and in the vaginal trial three (1, 16) days after vaginal hysterectomy and three (1, 19) days after laparoscopic hysterectomy. In the abdominal trial only 60% 177/292of patients who underwent abdominal hysterectomy were discharged by day 4 compared with 80% (492/584) after laparoscopic hysterectomy; in the vaginal trial 80% of patients in both the vaginal hysterectomy arm (135/168) and the laparoscopic hysterectomy arm (269/336) were discharged by day 4. We undertook no formal statistical testing, but these differences may be clinically important.
Table 4 Length of surgery in minutes, from first incision to last suture
Quality of life—All procedures were associated with improvements in the physical and mental components of SF-12, body image scale, and aspects of sexual activity at four months compared with baseline. These changes were maintained or improved further at 12 months. In the abdominal trial we found a highly significant difference in the physical component summary score of the SF-12 at six weeks between abdominal hysterectomy and laparoscopic hysterectomy (score -5.1, 95% confidence interval -7.1 to -3.2, P < 0.01). We also found highly significant differences in body image scale between abdominal hysterectomy and laparoscopic hysterectomy in the abdominal trial at six weeks (1.5, 0.5 to 2.4, P 0.01), a borderline significant difference at four months (1.1, 0.06 to 2.1, P = 0.06) but no difference at 12 months (table 5). According to the sexual activity questionnaire "habit" scores in this trial were higher at six weeks after laparoscopic hysterectomy than after abdominal hysterectomy (-0.3, 0.1 to 0.6, P 0.01). We found no evidence of a difference in quality of life at any time point in the vaginal trial.
Table 5 Mean (SD) SF-12 scores (abdominal trial). Difference at each time point
Predictors of major complication—Uterine descent and method of haemostasis of the uterine the ovarian pedicles were identified as significant predictors of major complications in patients undergoing laparoscopic hysterectomy (table 6). The vascular pedicles were sutured in only 7% (68/920) of cases, but this was associated with 25% (24/98) of all major complications; insufficient data were available to investigate this further.
Table 6 Odds ratios and 95% confidence intervals for predictive variables for laparoscopic hysterectomies
Discussion
Stoval TG, Summitt RL. Laparoscopic hysterectomy—is there a benefit? N Engl J Med 1996;335: 512-3.
Summitt RL, Stovall TG, Steege JF, Lipscomb GH. A multicentre randomized comparison of laparoscopically assisted vaginal hysterectomy and abdominal hysterectomy in abdominal hysterectomy candidates. Obstet Gynaecol 1998;92: 321-6.
Lumsden MA, Twaddle S, Hawthorn R, Traynor I, Gilmore D, Davis J, et al. A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy. Br J Obstet Gynaecol 2000;107: 1386-91.
Perino A, Cucinella G, Venezia R, Castelli A, Cittadini E. Total laparoscopic hysterectomy versus total abdominal hysterectomy: an assessment of the learning curve in a prospective randomized study. Hum Reprod 1999;14: 2996-9.
Falcone TMD, Paraiso MFR, Mascha EMS. Prospective randomized trial of laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy. Am J Obstet Gynecol 1999;180: 955-62.
Marana R, Busacca M, Zupi E, Garcea N, Paparella P, Catalano GF. Laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy: a prospective, randomized, multicenter study. Am J Obstet Gynaecol 1999;180: 270-5.
Ollson J, Ellstr?m M, Hahlin M. A randomised prospective trial comparing laparoscopic and abdominal hysterectomy. Br J Obstet Gynaecol 1996;103: 345-50.
Nezhat F, Nezhat C, Gordon S, Wilkin F. Laparoscopic versus abdominal hysterectomy. J Reprod Med 1992;37: 247-50.
Phipps JH, Nayak JS. Comparison of laparoscopic assisted vaginal hysterectomy and bilateral salpingo-oophorectomy with conventional abdominal hysterectomy and bilateral salpingo-oophorectomy. Br J Obstet Gynaecol 1993;100: 698-700.
Raju KS, Auld BH. A randomized prospective study of laparoscopic vaginal hysterectomy versus abdominal hysterectomy each with bilateral salpingo-ophorectomy. Br J Obstet Gynaecol 1994;101: 1068.
Langebrekke A, Eraker R, Nesheim B, Urnes A, Busund B, Sponland G. Abdominal hysterectomy should not be considered as a primary method for uterine removal. Acta Obstet Gynaecol Scand 1996;75: 404-7.
Soriano S, Goldstein A, Lecuru F, Darai E. Recovery from vaginal hysterectomy compared with laparoscopy-assisted vaginal hysterectomy. Acta Obstet Gynaecol 2001;80: 337-41.
Summitt RL, Stovall TG, Lipscombe GH, Ling RW. Randomized comparison of laparoscopy-assisted vaginal hysterectomy with standard vaginal hysterectomy in an outpatient setting. Obstet Gynaecol 1992;80: 895-9.
Richardson RE, Bournas N, Magios AL. Is laparoscopic hysterectomy a waste of time? Lancet 1995;345: 36-41.
Ottosen C, Lingman G, Ottosen L. Three methods for hysterectomy: a randomised, prospective study of short-term outcome. Br J Obstet Gynaecol 2000;107: 1380-5.
Thirlaway K, Fallowfield L, Cuzick J. The sexual activity questionnaire: a measure of women's sexual functioning. Qual Life Res 1996;5: 81-90.
Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer 2001;37: 189-97.
Ware JE, Kosinski M, Keller SD. SF-12 physical and mental health summary scales. Boston, MA: Health Institute, New England Medical Center, 1995.
Elashoff JD. nQuery Advisor Version 4.0 User's Guide. Los Angeles, CA, 2000.
Casey MJ, Garcia-Padial J, Johnson C, Osborne NG, Sotolongo J, Watson P. A critical analysis of laparoscopic assisted vaginal hysterectomies compared with vaginal hysterectomies unassisted by laparoscopy and transabdominal hysterectomies. J Gynaecol Surg 1994;10: 7-14.
Maresh MJ, Metcalfe MA, McPherson K, Overton C, Hall V, Hargreaves J, et al. The VALUE national hysterectomy study: description of the patients and their surgery. Br J Obstet Gynaecol 2002;109: 302-12.
Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990-1997. Obstet Gynecol 2002;99: 229-34.(Ray Garry, professor of c)
Correspondence to: R Garry rgarry@obsgyn.uwa.edu.au
Abstract
In 1996 Stovall and Summitt concluded that well designed clinical trials examining short term outcomes, economics, and quality of life were required to determine the role of laparoscopic hysterectomy.1 Ten previous randomised trials have compared outcomes for abdominal hysterectomy with laparoscopic hysterectomy.2-11 Most of these were from single centres of endoscopic surgical excellence and had small study populations. Each trial showed that laparoscopic hysterectomy was associated with reduced hospital stay and, in most studies, a shorter time to convalescence and notably less pain than abdominal hysterectomy.
Oonly four previously published randomised trials have compared the outcomes of vaginal hysterectomy and laparoscopic hysterectomy.12-15 The only difference shown in these studies was that laparoscopic hysterectomy took longer to perform.
We know of no previous trials that were powered to investigate the safety of the various procedures. We have therefore undertaken a concurrent pair of randomised controlled trials to eVALuate the relative roles of Vaginal, Abdominal, and Laparoscopic hysterectomy in routine gynaecological practice.
Methods
Forty three gynaecologists from 28 UK and two South African centres recruited 876 patients into the abdominal trial and 504 into the vaginal trial between November 1996 and September 2000. The recruitment target in the abdominal trial was therefore not reached. The trial steering committee closed the trials in September 2000 because funding ended and the rate of recruitment decreased.
Demography
Baseline characteristics were well matched in each of the allocated trials (table 1). The baseline characteristics between the two trials differed. More than 90% of the patients allocated to the vaginal trial had had one or more vaginal deliveries compared with less than 85% in the abdominal trial. This distribution was reversed for caesarean deliveries. Only one of 30 patients with palpable endometriosis was allocated to the vaginal trial. Patients with pelvic pain, more than one indication for hysterectomy, a fixed uterus, no uterine descent, or intended removal of the ovaries were more likely to be allocated to the abdominal trial.
Table 1 Baseline characteristics of participants in the two trials. Values are numbers (percentages) of participants unless otherwise indicated
The mean waiting times for the operations were similar, about 70 days. The main indications for hysterectomy were dysfunctional uterine bleeding (874/1380 cases, 63%), fibroids (235 cases, 17%), pelvic pain (151 cases, 11%), endometriosis (126 cases, 9%), and failed ablation (104 cases, 8%).
Numbers analysed
The figure shows the flow of patients through the trials. We performed a per protocol analysis as 46 (3.3%) patients were allocated to one procedure but had an alternative operation because of preoperative conversion (patient's decision (25 cases, 54%) and surgeon's unavailability (10 cases, 22%)). We undertook sensitivity analyses for the 34 patients who did not actually have an operation. Reasons for withdrawing preoperatively were mainly cancelled operations (25 cases, 74%).
Flow of participants through the trials. Among patients whose procedures were converted, 283 underwent abdominal hysterectomies and 576 laparoscopic hysterectomies in the abdominal trial; 173 underwent vaginal hysterectomies and 314 laparoscopic hysterectomies in the vaginal trial. Follow up forms not received within the appropriate time frames were not included in the analysis. The time frames were 14 days at six weeks and 28 days at four months and one year
Primary outcome
Table 2 details the major complications. Patients had up to four major complications. Of particular importance in the abdominal trial were severe haemorrhage following laparoscopic hysterectomy (4.6%) and abdominal hysterectomy (2.4%), as well as ureteric injuries in both trials. All six of the damaged ureters occurred in the laparoscopic hysterectomy arms. Unintended laparotomy was the second most common complication, affecting 45 patients; of these 13 had another major complication. The reasons given for the other conversions included additional pathology, poor access, removal of ovarian cyst, unable to secure haemostasis, and endometrial cancer.
Table 2 Primary end point of both trials: major complications. Values are numbers (percentages) of participants
In the abdominal trial significantly more patients undergoing laparoscopic hysterectomy than patients undergoing abdominal hysterectomy had at least one major complication (11.1% v 6.2%, mean difference 4.9%, 95% confidence interval 0.9% to 9.1%; odds ratio 1.91, 1.11 to 3.28). The number needed to treat to harm was 20. In this trial the odds of having a major complication was approximately twice as likely for patients undergoing laparoscopic hysterectomy.
We found no difference in the complication rates after the two procedures in the vaginal trial (9.8% for laparoscopic hysterectomy, 9.5% for vaginal hysterectomy (n = 18), mean difference 0.3%, -5.2% to 5.8%, P = 0.92; odds ratio 0.97, 0.52 to 1.81); the number needed to treat to harm was 333. However, this trial was not powered to detect a difference.
Per protocol and sensitivity analyses narrowed the size of difference between the types of operation for both trials, but the difference remained in the same direction. Adjustment for stratification factors made little difference to treatment effects.
Secondary outcomes
Minor complications—In the abdominal trial the percentage of patients who had at least one minor complication was 27.1% in patients undergoing abdominal hysterectomy compared with 25.2% for laparoscopic hysterectomy, and in the vaginal trial 27.9% for patients undergoing vaginal hysterectomy and 23.2% for laparoscopic hysterectomy (table 3). We found no evidence to show that there was any difference in minor complication rates between the procedures (P > 0.05) in any of the comparisons (intention to treat and sensitivity).
Table 3 Secondary end points of both trials: minor complications. Values are numbers (percentages) of patients
Additional pathology found during the operation—In the abdominal trial additional pathology was reported in 12.7% (373/292) of patients undergoing abdominal hysterectomy compared with 22.6% (132/584) undergoing laparoscopic hysterectomy (mean difference -9.9%, -15.4 to -4.4%, P = < 0.01). In the vaginal trial the rates were 4.8% (8/168) for vaginal hysterectomy and 16.4% (53/336) for laparoscopic hysterectomy (mean difference -11.6%, -17.7% to -5.5%, P = < 0.01). The main additional findings were adhesions, endometriosis, and fibroids.
Pain—In the abdominal trial abdominal hysterectomy was more painful than laparoscopic hysterectomy (adjusted mean pain score 3.9 abdominal hysterectomy, 3.5 laparoscopic hysterectomy; mean difference 0.4, 0.09 to 0.7, P = 0.01). A slightly higher proportion of patients undergoing abdominal hysterectomy used opiates than patients undergoing laparoscopic hysterectomy (80% v 76%). We found no evidence of a difference in pain scores in the vaginal trial. In this trial a higher proportion of patients undergoing vaginal hysterectomy (71%, 119/168) used opiates than patients undergoing laparoscopic hysterectomy (62%, 209/336).
Length of surgery and length of stay—Table 4 summarises the data for length of procedure. In the abdominal trial the median (minimum, maximum) length of stay after abdominal hysterectomy was four (1, 36) days and three (1, 36) days after laparoscopic hysterectomy, and in the vaginal trial three (1, 16) days after vaginal hysterectomy and three (1, 19) days after laparoscopic hysterectomy. In the abdominal trial only 60% 177/292of patients who underwent abdominal hysterectomy were discharged by day 4 compared with 80% (492/584) after laparoscopic hysterectomy; in the vaginal trial 80% of patients in both the vaginal hysterectomy arm (135/168) and the laparoscopic hysterectomy arm (269/336) were discharged by day 4. We undertook no formal statistical testing, but these differences may be clinically important.
Table 4 Length of surgery in minutes, from first incision to last suture
Quality of life—All procedures were associated with improvements in the physical and mental components of SF-12, body image scale, and aspects of sexual activity at four months compared with baseline. These changes were maintained or improved further at 12 months. In the abdominal trial we found a highly significant difference in the physical component summary score of the SF-12 at six weeks between abdominal hysterectomy and laparoscopic hysterectomy (score -5.1, 95% confidence interval -7.1 to -3.2, P < 0.01). We also found highly significant differences in body image scale between abdominal hysterectomy and laparoscopic hysterectomy in the abdominal trial at six weeks (1.5, 0.5 to 2.4, P 0.01), a borderline significant difference at four months (1.1, 0.06 to 2.1, P = 0.06) but no difference at 12 months (table 5). According to the sexual activity questionnaire "habit" scores in this trial were higher at six weeks after laparoscopic hysterectomy than after abdominal hysterectomy (-0.3, 0.1 to 0.6, P 0.01). We found no evidence of a difference in quality of life at any time point in the vaginal trial.
Table 5 Mean (SD) SF-12 scores (abdominal trial). Difference at each time point
Predictors of major complication—Uterine descent and method of haemostasis of the uterine the ovarian pedicles were identified as significant predictors of major complications in patients undergoing laparoscopic hysterectomy (table 6). The vascular pedicles were sutured in only 7% (68/920) of cases, but this was associated with 25% (24/98) of all major complications; insufficient data were available to investigate this further.
Table 6 Odds ratios and 95% confidence intervals for predictive variables for laparoscopic hysterectomies
Discussion
Stoval TG, Summitt RL. Laparoscopic hysterectomy—is there a benefit? N Engl J Med 1996;335: 512-3.
Summitt RL, Stovall TG, Steege JF, Lipscomb GH. A multicentre randomized comparison of laparoscopically assisted vaginal hysterectomy and abdominal hysterectomy in abdominal hysterectomy candidates. Obstet Gynaecol 1998;92: 321-6.
Lumsden MA, Twaddle S, Hawthorn R, Traynor I, Gilmore D, Davis J, et al. A randomised comparison and economic evaluation of laparoscopic-assisted hysterectomy and abdominal hysterectomy. Br J Obstet Gynaecol 2000;107: 1386-91.
Perino A, Cucinella G, Venezia R, Castelli A, Cittadini E. Total laparoscopic hysterectomy versus total abdominal hysterectomy: an assessment of the learning curve in a prospective randomized study. Hum Reprod 1999;14: 2996-9.
Falcone TMD, Paraiso MFR, Mascha EMS. Prospective randomized trial of laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy. Am J Obstet Gynecol 1999;180: 955-62.
Marana R, Busacca M, Zupi E, Garcea N, Paparella P, Catalano GF. Laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy: a prospective, randomized, multicenter study. Am J Obstet Gynaecol 1999;180: 270-5.
Ollson J, Ellstr?m M, Hahlin M. A randomised prospective trial comparing laparoscopic and abdominal hysterectomy. Br J Obstet Gynaecol 1996;103: 345-50.
Nezhat F, Nezhat C, Gordon S, Wilkin F. Laparoscopic versus abdominal hysterectomy. J Reprod Med 1992;37: 247-50.
Phipps JH, Nayak JS. Comparison of laparoscopic assisted vaginal hysterectomy and bilateral salpingo-oophorectomy with conventional abdominal hysterectomy and bilateral salpingo-oophorectomy. Br J Obstet Gynaecol 1993;100: 698-700.
Raju KS, Auld BH. A randomized prospective study of laparoscopic vaginal hysterectomy versus abdominal hysterectomy each with bilateral salpingo-ophorectomy. Br J Obstet Gynaecol 1994;101: 1068.
Langebrekke A, Eraker R, Nesheim B, Urnes A, Busund B, Sponland G. Abdominal hysterectomy should not be considered as a primary method for uterine removal. Acta Obstet Gynaecol Scand 1996;75: 404-7.
Soriano S, Goldstein A, Lecuru F, Darai E. Recovery from vaginal hysterectomy compared with laparoscopy-assisted vaginal hysterectomy. Acta Obstet Gynaecol 2001;80: 337-41.
Summitt RL, Stovall TG, Lipscombe GH, Ling RW. Randomized comparison of laparoscopy-assisted vaginal hysterectomy with standard vaginal hysterectomy in an outpatient setting. Obstet Gynaecol 1992;80: 895-9.
Richardson RE, Bournas N, Magios AL. Is laparoscopic hysterectomy a waste of time? Lancet 1995;345: 36-41.
Ottosen C, Lingman G, Ottosen L. Three methods for hysterectomy: a randomised, prospective study of short-term outcome. Br J Obstet Gynaecol 2000;107: 1380-5.
Thirlaway K, Fallowfield L, Cuzick J. The sexual activity questionnaire: a measure of women's sexual functioning. Qual Life Res 1996;5: 81-90.
Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer 2001;37: 189-97.
Ware JE, Kosinski M, Keller SD. SF-12 physical and mental health summary scales. Boston, MA: Health Institute, New England Medical Center, 1995.
Elashoff JD. nQuery Advisor Version 4.0 User's Guide. Los Angeles, CA, 2000.
Casey MJ, Garcia-Padial J, Johnson C, Osborne NG, Sotolongo J, Watson P. A critical analysis of laparoscopic assisted vaginal hysterectomies compared with vaginal hysterectomies unassisted by laparoscopy and transabdominal hysterectomies. J Gynaecol Surg 1994;10: 7-14.
Maresh MJ, Metcalfe MA, McPherson K, Overton C, Hall V, Hargreaves J, et al. The VALUE national hysterectomy study: description of the patients and their surgery. Br J Obstet Gynaecol 2002;109: 302-12.
Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990-1997. Obstet Gynecol 2002;99: 229-34.(Ray Garry, professor of c)