Mart&as, 15 (1992) 3-6 Elsevier Scientific Publishers Ireland Ltd.
MAT 00692
Personal Opinion
Hysterectomy:
Is there a need for a clinical trial? Gloria A. Bachmann
Division of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey-Robert Johnson Medical School, New Brunswick, New Jersey (USA)
Wood
Hysterectomy, the second most common operation today; with the majority of cases done in perimenopausal women usually performed for symptomatic relief. Consequently controversy exists on the appropriateness of indications. A clinical trial is proposed to study this question.
Key words: hysterectomy; perimenopausal;
clinical trial
Introduction Since the first hysterectomy, described in the third century A.D. writings of Soranus, this operation has become widely accepted as a curative and pallative procedure and is the second most frequent major surgical procedure in the United States today [l]. After peaking at an annual level of over 725 000 operations in 1975, procedures are performed annually at a hospital cost of approximately three billion dollars [2]. Hysterectomy is most frequently done during the perimenopausal years and the majority of hysterectomies are performed to relieve symptoms rather than for life threatening pathology. There exists a marked variation of hysterectomy rates among geographic regions and socioeconomic strata [2]. In addition, unlike most other surgery, hysterectomy has been associated with various psychosexual disturbances and is viewed by some women as a threat to their perception of femininity [3]. Prior to this century, hysterectomy carried a very high mortality rate approaching 90% such that the operation was performed only when the woman’s life was at grave risk. Although technological developments in medical procedures and equipment, blood banking, anesthesia, antisepsis and antibiotics have lowered the mortality rate to approximately 12/10 000 procedures and in so doing have liberalized indications for this operation, the financial models of health care delivery are moving in the direction of reduction in health care expenditures and in so doing are placing more restrictions on the indications for the performance of hysterectomy [4]. Correspondence to: G.A. Bachmann, Division of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
4
Controversy exists today on the appropriate indications for hysterectomy, especially when done in asymptomatic or minimally symptomatic women without life threatening disorders or in cases where no uterine pathology is identified. The medical professions’ reexamination of the clinical necessity to perform hysterectomy for symptomatic relief is in part due to the imperative to contain health care costs as well as such factors as the rapid rise of surgeries performed in this country, the recent advances in surgical technology (e.g. lasers), which often allow uterine retention, the increasingly vocal patient advocate groups who often claim that many hysterectomies are not surgically warranted and the belief of some professionals and consumers that the effectiveness of many medical practices, such as hysterectomy, is questionable or, in certain instances, entirely lacking [5]. Indications to perform a surgical procedure fall into three broad categories: to prevent mortality, to restore function and alleviate symptoms. Uterine removal as part of the treatment regimen often is a necessary and potentially lifesaving procedure in patients with pelvic cancer. Hysterectomy is often indicated when uterine pathology interferes with urogenital function or is impairing on other organs (e.g. large leiomyomata, uterine prolapse). The justification of hysterectomy to relieve suffering is the area of medicine on which the current debate centers; no set objective criteria defining these indications for hysterectomy are universally agreed upon. Therefore, the appropriateness of the surgery for each case involving benign disease must be individualized and disagreement among professionals is expected. At a recent American College of Surgeons meeting, it was reported that in a California study, 2/3 of 650 consecutive proposed hysterectomies were deemed inappropriate by a quantitative screening method used in precertification. After additional physician scrutiny, more than l/3 of the operations were still vetoed [6]. However, the effect of screening programs such as this one on the patient’s health has not been adequately studied. It is possible that by avoiding or postponing hysterectomy, women may derive either untoward or beneficial health effects. Today, the decision to perform an operation such as a hysterectomy does not rest solely with the physician or the physician with patient input as in the past but the decision is influenced by factors outside of the doctor’s office. That is, the decision is often made after consideration of the interests of third party payers, usually wishing to minimize the number of ‘unnecessary’ procedures; hospital administrators who may wish to maximize fiscally favorable hospital admissions and welcome the performance of elective, low risk operations on otherwise healthy patients; quality assurance programs interested in adequate documentation and adherence to preset, rigid criteria; often mandatory second opinions seeking to insure valid indications for the proposed surgery; the standard of practice in the geographic region; the patient in consultation with her family and friends; and finally the medical judgment of the physician. Therefore, uniformity in selecting appropriate patients for hysterectomy is not often feasible because absolute indications for hysterectomy are difficult to define and professionals, viewing hysterectomy from different perspectives, will often disagree on the appropriate weights to be assigned to the different factors (mortality, suffering, emotional factors, finances, etc.) that come into consideration when the decision for hysterectomy is made. Unfortunately, large scale, double blind studies evaluating pre- and postoperative quali-
5
ty of life issues are not available that document patient outcome either with or without uterine extirpation and therefore objective criteria often cannot be applied in the decision making process. Need for a clinical trial Since indications for hysterectomy have not been universally agreed upon, a major question that has not been satisfactorily answered is whether the current rate of hysterectomy, where the majority of cases are performed for benign conditions, is appropriate. While attempts have been made to answer this question using historical data, small prospective studies and metaanalytical techniques, it appears that this question also can only be definitely answered with a randomized clinical trial with short and long term mortality and morbidity as well as quality of life outcomes and symptom relief as endpoints. In spite of the vast body of literature on hysterectomy and the major developments that have occurred in the operative, clinical, epidemiologic, pathophysiologic and psychosexual aspects of hysterectomy, the indications for hysterectomy to alleviate patient suffering remain to be clarified. Since most hysterectomies are performed to improve quality of life, the prevalence, natural history and personal and existential importance of the symptoms associated with benign disorders that lead to a large proportion of hysterectomies must be studied. Further, the effect of hysterectomy on the alleviation of the symptoms prompting the surgery has not been adequately researched in a formal way. Appropriate methodologies must be applied for ascertaining the short and long term beneficial and adverse affects of hysterectomy on pain, physical, hormonal and psychosexual state and overall quality of life. Likewise, alternatives to hysterectomy should be carefully examined to determine their effectiveness in comparison to hysterectomy, to evaluate their short and long term adverse effects in comparison to those of hysterectomy and to study their direct and indirect expenditures. Clinical trial methodology has been developed in other disciplines where worldwide clinical practice has changed as a result of these trials (e.g. treatment of hypertension, myocardial infarction and hypercholesterolemia). It can be argued that hysterectomy should also be studied in the same way. While the FDA requires extensive safety and efficacy studies before approving new drugs, surgical procedures in general are not subject to this same scrutiny. Outcomes from large clinical trials have been criticized mainly because of the expense incurred and concerns regarding the general applicability of the findings. However, they still remain the major tool in deciding the appropriate course of action in common clinical problems. In addition, newer techniques utilizing very well defined protocols with limited sharply outlined dependent variables and a large number of investigators have allowed the conduct of very large (e.g. 20 000 patients) clinical trials with modest expenditures and generally accepted results with wide clinical applicability [7]. Knowledge regarding hysterectomy versus non-surgical alternatives or surgery with preservation of the uterus obtained from a large scale clinical trial would allow more informed choices to be made by both the physician and patient regarding the circumstances where hysterectomy is the treatment of choice. Studies comparing aorto-coronary
6
bypass surgery to medical therapy or to percutaneous transluminal coronary angioplasty conducted by NIH as well as abroad may serve as a model [8]. Summary In summary, the current criteria used to decide whether hysterectomy is appropriate for a given patient must be more objectively scrutinized. The data necessary to refine the indications and evaluate the varied medical, psychological and fiscal outcomes can be obtained by well designed clinical trials. The great epidemiologic importance of hysterectomy, the second most common major surgical procedure, justifies this approach. References Benrubi GA. History of hysterectomy. J Fla Med Assoc 1988; 75: 533-538. Hysterectomy in the United States, 1965-84, Vital Health Stat 1988; 13. Bachmann GA. Psychosexual aspects of hysterectomy. Women’s Health Issues 1990; 1: 41-48. Wingo PA, Huezo CM, Rubin GL et al. The mortality risk associated with hysterectomy. Am J Obstet Gynecol 1985; 152: 803-808. Bachmann GA. Hysterectomy: a critical review. J Reprod Med 1990; 35: 839-862. Avoiding unnecessary hysterectomies. Ob Gyn News 1990; 25: 2. In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarction randomized between alteplase and stretokinase with or without heparin. The International Study Group. Lancet 1990; 336: 71-75. Bari, Cabri, East, Gabi and Kita; coronary angioplasty on trial (editorial). Lancet 1990; 335: 1315-1316.
MAT 00692
Personal Opinion
Hysterectomy:
Is there a need for a clinical trial? Gloria A. Bachmann
Division of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey-Robert Johnson Medical School, New Brunswick, New Jersey (USA)
Wood
Hysterectomy, the second most common operation today; with the majority of cases done in perimenopausal women usually performed for symptomatic relief. Consequently controversy exists on the appropriateness of indications. A clinical trial is proposed to study this question.
Key words: hysterectomy; perimenopausal;
clinical trial
Introduction Since the first hysterectomy, described in the third century A.D. writings of Soranus, this operation has become widely accepted as a curative and pallative procedure and is the second most frequent major surgical procedure in the United States today [l]. After peaking at an annual level of over 725 000 operations in 1975, procedures are performed annually at a hospital cost of approximately three billion dollars [2]. Hysterectomy is most frequently done during the perimenopausal years and the majority of hysterectomies are performed to relieve symptoms rather than for life threatening pathology. There exists a marked variation of hysterectomy rates among geographic regions and socioeconomic strata [2]. In addition, unlike most other surgery, hysterectomy has been associated with various psychosexual disturbances and is viewed by some women as a threat to their perception of femininity [3]. Prior to this century, hysterectomy carried a very high mortality rate approaching 90% such that the operation was performed only when the woman’s life was at grave risk. Although technological developments in medical procedures and equipment, blood banking, anesthesia, antisepsis and antibiotics have lowered the mortality rate to approximately 12/10 000 procedures and in so doing have liberalized indications for this operation, the financial models of health care delivery are moving in the direction of reduction in health care expenditures and in so doing are placing more restrictions on the indications for the performance of hysterectomy [4]. Correspondence to: G.A. Bachmann, Division of Obstetrics and Gynecology, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
4
Controversy exists today on the appropriate indications for hysterectomy, especially when done in asymptomatic or minimally symptomatic women without life threatening disorders or in cases where no uterine pathology is identified. The medical professions’ reexamination of the clinical necessity to perform hysterectomy for symptomatic relief is in part due to the imperative to contain health care costs as well as such factors as the rapid rise of surgeries performed in this country, the recent advances in surgical technology (e.g. lasers), which often allow uterine retention, the increasingly vocal patient advocate groups who often claim that many hysterectomies are not surgically warranted and the belief of some professionals and consumers that the effectiveness of many medical practices, such as hysterectomy, is questionable or, in certain instances, entirely lacking [5]. Indications to perform a surgical procedure fall into three broad categories: to prevent mortality, to restore function and alleviate symptoms. Uterine removal as part of the treatment regimen often is a necessary and potentially lifesaving procedure in patients with pelvic cancer. Hysterectomy is often indicated when uterine pathology interferes with urogenital function or is impairing on other organs (e.g. large leiomyomata, uterine prolapse). The justification of hysterectomy to relieve suffering is the area of medicine on which the current debate centers; no set objective criteria defining these indications for hysterectomy are universally agreed upon. Therefore, the appropriateness of the surgery for each case involving benign disease must be individualized and disagreement among professionals is expected. At a recent American College of Surgeons meeting, it was reported that in a California study, 2/3 of 650 consecutive proposed hysterectomies were deemed inappropriate by a quantitative screening method used in precertification. After additional physician scrutiny, more than l/3 of the operations were still vetoed [6]. However, the effect of screening programs such as this one on the patient’s health has not been adequately studied. It is possible that by avoiding or postponing hysterectomy, women may derive either untoward or beneficial health effects. Today, the decision to perform an operation such as a hysterectomy does not rest solely with the physician or the physician with patient input as in the past but the decision is influenced by factors outside of the doctor’s office. That is, the decision is often made after consideration of the interests of third party payers, usually wishing to minimize the number of ‘unnecessary’ procedures; hospital administrators who may wish to maximize fiscally favorable hospital admissions and welcome the performance of elective, low risk operations on otherwise healthy patients; quality assurance programs interested in adequate documentation and adherence to preset, rigid criteria; often mandatory second opinions seeking to insure valid indications for the proposed surgery; the standard of practice in the geographic region; the patient in consultation with her family and friends; and finally the medical judgment of the physician. Therefore, uniformity in selecting appropriate patients for hysterectomy is not often feasible because absolute indications for hysterectomy are difficult to define and professionals, viewing hysterectomy from different perspectives, will often disagree on the appropriate weights to be assigned to the different factors (mortality, suffering, emotional factors, finances, etc.) that come into consideration when the decision for hysterectomy is made. Unfortunately, large scale, double blind studies evaluating pre- and postoperative quali-
5
ty of life issues are not available that document patient outcome either with or without uterine extirpation and therefore objective criteria often cannot be applied in the decision making process. Need for a clinical trial Since indications for hysterectomy have not been universally agreed upon, a major question that has not been satisfactorily answered is whether the current rate of hysterectomy, where the majority of cases are performed for benign conditions, is appropriate. While attempts have been made to answer this question using historical data, small prospective studies and metaanalytical techniques, it appears that this question also can only be definitely answered with a randomized clinical trial with short and long term mortality and morbidity as well as quality of life outcomes and symptom relief as endpoints. In spite of the vast body of literature on hysterectomy and the major developments that have occurred in the operative, clinical, epidemiologic, pathophysiologic and psychosexual aspects of hysterectomy, the indications for hysterectomy to alleviate patient suffering remain to be clarified. Since most hysterectomies are performed to improve quality of life, the prevalence, natural history and personal and existential importance of the symptoms associated with benign disorders that lead to a large proportion of hysterectomies must be studied. Further, the effect of hysterectomy on the alleviation of the symptoms prompting the surgery has not been adequately researched in a formal way. Appropriate methodologies must be applied for ascertaining the short and long term beneficial and adverse affects of hysterectomy on pain, physical, hormonal and psychosexual state and overall quality of life. Likewise, alternatives to hysterectomy should be carefully examined to determine their effectiveness in comparison to hysterectomy, to evaluate their short and long term adverse effects in comparison to those of hysterectomy and to study their direct and indirect expenditures. Clinical trial methodology has been developed in other disciplines where worldwide clinical practice has changed as a result of these trials (e.g. treatment of hypertension, myocardial infarction and hypercholesterolemia). It can be argued that hysterectomy should also be studied in the same way. While the FDA requires extensive safety and efficacy studies before approving new drugs, surgical procedures in general are not subject to this same scrutiny. Outcomes from large clinical trials have been criticized mainly because of the expense incurred and concerns regarding the general applicability of the findings. However, they still remain the major tool in deciding the appropriate course of action in common clinical problems. In addition, newer techniques utilizing very well defined protocols with limited sharply outlined dependent variables and a large number of investigators have allowed the conduct of very large (e.g. 20 000 patients) clinical trials with modest expenditures and generally accepted results with wide clinical applicability [7]. Knowledge regarding hysterectomy versus non-surgical alternatives or surgery with preservation of the uterus obtained from a large scale clinical trial would allow more informed choices to be made by both the physician and patient regarding the circumstances where hysterectomy is the treatment of choice. Studies comparing aorto-coronary
6
bypass surgery to medical therapy or to percutaneous transluminal coronary angioplasty conducted by NIH as well as abroad may serve as a model [8]. Summary In summary, the current criteria used to decide whether hysterectomy is appropriate for a given patient must be more objectively scrutinized. The data necessary to refine the indications and evaluate the varied medical, psychological and fiscal outcomes can be obtained by well designed clinical trials. The great epidemiologic importance of hysterectomy, the second most common major surgical procedure, justifies this approach. References Benrubi GA. History of hysterectomy. J Fla Med Assoc 1988; 75: 533-538. Hysterectomy in the United States, 1965-84, Vital Health Stat 1988; 13. Bachmann GA. Psychosexual aspects of hysterectomy. Women’s Health Issues 1990; 1: 41-48. Wingo PA, Huezo CM, Rubin GL et al. The mortality risk associated with hysterectomy. Am J Obstet Gynecol 1985; 152: 803-808. Bachmann GA. Hysterectomy: a critical review. J Reprod Med 1990; 35: 839-862. Avoiding unnecessary hysterectomies. Ob Gyn News 1990; 25: 2. In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarction randomized between alteplase and stretokinase with or without heparin. The International Study Group. Lancet 1990; 336: 71-75. Bari, Cabri, East, Gabi and Kita; coronary angioplasty on trial (editorial). Lancet 1990; 335: 1315-1316.
