Effect of selective estrogen receptor modulators on reproductive tissues other than endometrium.

The objective of this paper is to review the published and unpublished knowledge of the effect of selective estrogen receptor modulators on reproductive tissues other than endometrium. Pharmaceutical companies developing or marketing selective estrogen receptor modulators (SERMs) were identified. The investigators at each company responsible for the conduct of investigational trials were contacted and queried about reports of adverse events in any ongoing or completed trials involving SERMs produced by their company. Levormeloxifene and idoxifene trials noted a higher proportion of surgery for pelvic organ prolapse in treated versus untreated women. The development of these pharmaceutical agents was discontinued, primarily for endometrial concerns. However, pelvic organ prolapse was reported to the FDA as an adverse event associated with both drugs. Study weaknesses preclude a definitive association between the agents and pelvic organ prolapse. The treated groups were not necessarily similar for confounding factors such as age, parity, obesity, cigarette smoking, and other risk factors for pelvic organ prolapse. Tamoxifen and raloxifene increase hot flash intensity and frequency. Ovarian cyst formation and uterine fibroid growth have also been reported with some SERMs. The identification and assessment of the impact of current and future SERMs on the pelvic floor and other genital tissues will be important to understanding their potential long-term application in disease treatment and prevention.

The legendary superior strength of the Pfannenstiel incision: a myth?

OBJECTIVE: This study was undertaken to determine whether there is a difference in the frequency of fascial dehiscence between midline vertical lower abdominal and Pfannenstiel incisions among women undergoing obstetric and gynecologic operations. STUDY DESIGN: A case-control study of 48 cases of fascial dehiscence complicating 17, 995 major operations (8950 cesarean deliveries and 9405 gynecologic procedures) during a 6-year period at Wayne State University Hutzel Hospital, Detroit, was performed. Univariate analysis identified significant independent variables related to fascial dehiscence. Stepwise logistic regression analysis then identified those risk factors that were independently associated with fascial dehiscence. RESULTS: Among the 48 patients who underwent repair of fascial dehiscence after a major obstetric or gynecologic operation, 27 were from the obstetric service and 21 were from the benign and cancer gynecologic services. Wound dehiscence occurred in 10 vertical incisions and 17 Pfannenstiel incisions among the obstetric patients and in 12 vertical and 9 Pfannenstiel incisions among the gynecologic patients. The risk for dehiscence with vertical lower abdominal incisions was not increased with respect to that associated with Pfannenstiel incisions (P =.39, 2-tailed). This finding was true for all patients (odds ratio, 1.3; 95% confidence interval, 0.7-2.6), obstetric patients (odds ratio, 1.3; 95% confidence interval, 0.5-3.4), and gynecologic patients (odds ratio, 1.5; 95% confidence interval, 0.5-4.0). Forty-seven of the 48 case patients had documented wound infections, compared with 1 of the 144 control subjects (P <.0001, odds ratio, 37.8; 95% confidence interval, 14.8-96.8). CONCLUSION: Wound infection was the most important risk factor for fascial dehiscence among women who underwent major obstetric and gynecologic operations. Our results do not support the long-held belief that Pfannenstiel incisions are stronger than lower abdominal vertical incisions and reduce the risk for fascial dehiscence.

Transvaginal ultrasound-guided aspiration of pelvic abscesses.

OBJECTIVE: To assess the utility of a less invasive approach to the care of women with a pelvic abscess, we retrospectively reviewed the outcome of women with pelvic abscesses managed by transvaginal ultrasound-guided aspiration. METHODS: A retrospective analysis of 27 pelvic abscesses in 22 consecutive women undergoing transvaginal drainage, including 13 tuboovarian abscesses (TOAs) and 14 postoperative abscesses (POAs). All patients received broad-spectrum intravenous antibiotics from the time infection was diagnosed to resolution of signs and symptoms. Chart review and examination of ultrasound files were utilized to extract demographic clinical, laboratory, and outcome data. RESULTS: The mean age for the study group was 30 years old. Mean duration from diagnosis to drainage was 5.6 days (TOA) and 2.0 days (POA), P < 0.01. The mean diameter of the abscesses was 86 mm. The volume of purulent material drained ranged from 70-750 mL. Perceived adequacy of drainage was correlated with lack of abscess septation. Cultures for aerobic and anaerobic pathogens were positive in 51% of cases (79% POA versus 23% TOA, P < 0.05) with 1.9 organisms/ positive culture. Transvaginal drainage was successful in 25 of 27 abscesses. No complications were reported. CONCLUSION: In skilled hands, transvaginal guided aspiration of pelvic abscess is a highly successful technique with minimal risk to the patient. Follow-up studies are needed to assess the long-term sequelae, such as frequency of infertility, ectopic pregnancy, and chronic pelvic pain.

Synthetic graft placement in the treatment of fascial dehiscence with necrosis and infection.

OBJECTIVE: The objective of this study was to describe the use of synthetic grafts in repairing fascial dehiscence complicated by fascial necrosis and infection after obstetric and gynecologic operations. STUDY DESIGN: A retrospective review of the operating room records at Hutzel Hospital (Detroit, Mich) was performed to find all cases of fascial dehiscence repaired during a 6-year period between January 1, 1991, and December 31, 1996. Patients with partial or complete disruption of the fascia with evidence of fascial necrosis and infection were included in this study. Demographic information; the initial surgical procedure, including type of incision; suture material; use of synthetic graft and closure technique for repair of dehiscence; postoperative complications, microbiologic results; antibiotic therapy; subsequent operations; length of hospital stay; and late complications were recorded. RESULTS: During the study period 52 patients underwent repair of fascial dehiscence; 36 of these had concurrent fascial necrosis and infection, including 4 women with necrotizing fasciitis. Eighteen patients were from the obstetric service and 18 were from the benign or cancer gynecology service. Ninety-one bacterial isolates were recovered from the infected wounds. Extensive fascial resection precluded closure without tension in 18 cases and necessitated synthetic graft placement to prevent evisceration. Graft materials included polypropylene (11 cases) and polyglactin (7 cases). Late complications of graft placement included extrusion of the graft in 3 patients and incisional hernia in 1. CONCLUSIONS: Extensive fascial débridement with resection prevents primary closure of wound dehiscence. Synthetic grafts permit primary closure of large fascial defects and can be used with extensive débridement in the presence of infection.

Medically sound, cost-effective treatment for pelvic inflammatory disease and tuboovarian abscess.

OBJECTIVE: Our purpose was to determine the clinical effectiveness and cost-effectiveness of three antibiotic regimens for the treatment of pelvic inflammatory disease and tuboovarian abscess. STUDY DESIGN: A review of all patients' hospitalized at Hutzel Hospital, Detroit, Michigan, for treatment of pelvic inflammatory disease and tuboovarian abscess between Jan. 1, 1993, and April 30, 1997, was performed. Demographic data, antibiotic choices, changes in therapy, operative interventions, and cost of therapy were assessed. RESULTS: Two hundred three patients were admitted for treatment of pelvic inflammatory disease during the study period. We were able to evaluate the clinical efficacy of antibiotic treatment in 179 patients, including 105 patients with pelvic inflammatory disease alone (uncomplicated pelvic inflammatory disease) and 74 women whose infection was complicated by tuboovarian abscess. The three antibiotic regimens evaluated were cefotetan plus doxycycline, clindamycin plus gentamicin, and ampicillin plus clindamycin plus gentamicin. All regimens demonstrated comparable efficacy in treating uncomplicated genital tract infections. Ampicillin plus clindamycin plus gentamicin was significantly better than clindamycin plus gentamicin and cefotetan plus doxycycline in treatment of tuboovarian abscess (p = 0.001). Fifteen women with tuboovarian abscess responded to a change to ampicillin plus gentamicin plus clindamycin antibiotic therapy alone. The hospital stay was prolonged by approximately 3 days in women failing to respond to initial antibiotic therapy, and operative interventions were common in this group of patients. CONCLUSIONS: Cefotetan plus oral doxycycline is the most cost-effective regimen for treating uncomplicated pelvic inflammatory disease, whereas triple-antibiotic therapy is the treatment of choice in women with tuboovarian abscess.

The development and implementation of normal vaginal delivery clinical pathways in a large multihospital health system.

The entire country has become more concerned with healthcare costs due to managed care, capitation risk-based contracts, and the near elimination of the cost-plus reimbursement system. Clinical pathways have become one way to reduce unnecessary resource consumption by reducing provider variance, improving clinical outcomes, and reducing cost. We present here our rationale and process for developing a common clinical pathway for normal vaginal delivery in a large and varied multihospital system. We also discuss how this new pathway is expected to improve quality of care and reduce costs.

A cost-effectiveness evaluation of preoperative type-and-screen testing for vaginal hysterectomy.

OBJECTIVE: Our purpose was to evaluate the usefulness and cost-effectiveness of routine preoperative type-and-screen testing before vaginal hysterectomy. STUDY DESIGN: A retrospective review of all vaginal hysterectomies performed at Hutzel Hospital between 1988 and 1994 with an emphasis on those that required blood transfusion was done. All vaginal hysterectomies completed at Hutzel Hospital were included in this 6-year time period for all noncancerous indications, including fibroid uterus, endometriosis, menorrhagia, uterine prolapse, pelvic pain, cervical dysplasia, and adenomyosis. RESULTS: Among 1063 patients who underwent vaginal hysterectomy, 26 needed a blood transfusion at the time of hospitalization. Medical records of the patients who needed blood transfusions were reviewed to determine the urgency and indication. Ten of the transfusions were given preoperatively because of anemia, 7 were given intraoperatively, and 9 were given postoperatively. The seven intraoperative transfusions were given because of the physician's perception of excessive blood loss; however, none of the patients received an emergency transfusion with extreme urgency. That is, the need for the intraoperative transfusion was not immediate. All patients who received a transfusion could have waited for 20 to 30 minutes for proper type and crossmatching and subsequent transfusion. CONCLUSION: In the absence of preoperative indications, routine preoperative type-and-screen testing of blood before vaginal hysterectomy is not cost-effective, does not enhance patient care, and should be eliminated.

A cost-effectiveness evaluation of laparoscopic disposable versus nondisposable infraumbilical cannulas.

STUDY OBJECTIVE: To compare the safety and cost-effectiveness of disposable and nondisposable infraumbilical laparoscopic cannulas. DESIGN: Retrospective review of consecutive laparoscopic procedures performed from July 1, 1988, to June 30, 1994. SETTING: A university-affiliated hospital. Patients. The 10,459 consecutive women who underwent laparoscopies. INTERVENTIONS: A 10-mm disposable cannula was used in 529 laparoscopies and a nondisposable cannula in 9930, based on physician preference. MEASUREMENTS AND MAIN RESULTS: The only intraabdominal injuries associated with insertion of disposable and nondisposable cannulas were bowel injuries in one and three patients, respectively. The injury rates for the instruments were 19 and 3/10,000 cases, respectively, but were not statistically different (P <0.05, Fisher's two-tail exact test). The hospital cost per disposable cannula in 1994 was $63.71; the cost per procedure with the nondisposable cannula was amortized and was less than $1.35, including maintenance. CONCLUSION: Disposable cannulas were not cost effective and were associated with a higher but not statistically significant complication rate. Therefore, the more expensive disposable cannulas are not recommended.

A cost analysis of endometrial ablation, abdominal hysterectomy, vaginal hysterectomy, and laparoscopic-assisted vaginal hysterectomy in the treatment of primary menorrhagia.

STUDY OBJECTIVE: To assess the cost of four procedures performed to treat primary menorrhagia. DESIGN: Retrospective analysis. Setting. A 394-bed womens' teaching hospital. PATIENTS: Eighty healthy women undergoing one of the four procedures. Interventions. The study patients were equally divided among vaginal hysterectomy (VH), total abdominal hysterectomy (TAH), laparoscopic-assisted vaginal hysterectomy (LAVH), and endometrial ablation (EA). MEASUREMENTS AND MAIN RESULTS: Endometrial ablation was associated with significantly reduced hospital costs and a shorter recovery period than the other modalities. Hospital costs were less for VH and return to work was quicker after LAVH and VH. This study did not evaluate long-term failures or complications unless they occurred within the first 2 months after the procedure. CONCLUSION: Among women who could be treated by any of these techniques, VH was significantly more cost effective for the permanent management of primary menorrhagia than LAVH and TAH. The cost efficiency of EA was clearly implied, but further studies must be completed to evaluate the long-term costs associated with treatment failures. Although physicians should not choose a procedure based exclusively on cost, the expense of a less efficient or more costly procedure may affect a hospital's competitiveness in this era of managed care.

The effect of capitated and fee-for-service remuneration on physician decision making in gynecology.

OBJECTIVE: To evaluate the variations in physician behavior leading to performance of gynecologic surgical procedures related to fee-for-service and capitation reimbursement systems. METHODS: This study compared the physician practice utilization of surgical services for fee-for-service and capitated contract reimbursement systems within a gynecology clinic. Attending gynecologists were reimbursed on a fee-for-service basis for all surgical services performed during a 6-month interval; subsequently, the same physicians were reimbursed on a capitated basis for 6 months and received a fixed payment for the clinical and surgical services provided. RESULTS: Three thousand seven hundred eighty consecutive outpatient gynecology visits were evaluated at the university gynecology clinic during 1994. We found a 15% overall decrease in the number of surgical procedures that were performed during the capitated reimbursement period compared with the fee-for-service time interval. The procedure most responsible for the reduction of surgical services was elective sterilization by laparoscopy, which underwent a statistically significant decrease (P < .01). CONCLUSION: The remuneration system in our review seemed to affect physician decision making for only the most elective procedures, whereas physicians maintained similar practice patterns for more severe conditions. Fee-for-service seems to encourage, whereas capitation seems to discourage, gynecologist from performing elective procedures.

Cost-effectiveness of routine blood type and screen testing before elective laparoscopy.

OBJECTIVE: To evaluate the usefulness and cost-effectiveness of the routine preoperative evaluation of blood type and screen testing before laparoscopy. METHODS: A retrospective review was conducted in patients transfused with blood during or after laparoscopy over a 3-year period at Hutzel Hospital, Detroit, Michigan; Grace Hospital, Southfield, Michigan; and Bixby Medical Center, Adrian, Michigan. RESULTS: Of 7529 women receiving laparoscopic procedures, 57 required blood transfusion at laparoscopy. Medical records of the 57 patients requiring blood transfusion were evaluated as to urgency and indication. All 57 subsequent blood transfusions were found to be the result of previously identifiable problems, including ectopic pregnancy and preoperative anemia. No patient required transfusion for a vascular injury. CONCLUSION: In the absence of preoperative indications, routine preoperative type and screen testing for elective and emergency laparoscopic procedures does not enhance patient care and should be eliminated.

Primary and preventive care in a university obstetrics and gynecology group practice.

OBJECTIVE: Our purpose was to determine whether primary and preventive care is practiced by a university obstetrician-gynecologist group practice. STUDY DESIGN: A retrospective chart review spanning 2 years of four academic physicians' private practices was performed. A total of 335 patients were reviewed with 739 patient encounters and 1032 patient problems identified. The definition of a primary care physician according to The American College of Obstetricians and Gynecologists was used to standardize data collection and evaluation. RESULTS: Obstetric complaints accounted for 27.7% of all visits, whereas 65.4% were for gynecologic problems. Almost 7% of all complaints were neither obstetric nor gynecologic, and of those 74.6% were primary care problems completely managed by the obstetrician-gynecologist. Only 19.7% of these were referred for management. More than 89% of all encounters (659/739) involved some element of primary care. CONCLUSION: This study provides evidence that the majority of health care provided by the obstetrician-gynecologist is primary care.

Group B streptococcus meningitis following elective termination of pregnancy: two case reports.

BACKGROUND: Although maternal group B streptococcus (GBS) infections are common, serious infections are rare with prompt diagnosis and treatment. We present 2 cases of GBS meningitis occurring 3 and 10 days after elective abortion. In the first patient, GBS meningitis was definitely related to the elective termination. In the second patient, however, no evidence for a causal relationship could be established and can only be presumed. CASE: The patients presented to the emergency department with headache, altered mental status, and fever. Their physical examinations were consistent with meningitis and confirmed by cerebrospinal fluid (CSF) analysis. One patient recovered completely and the other developed severe bilateral hearing loss. CONCLUSION: GBS meningitis is rare, occurring in men and women. When associated with pregnancy, most cases present within 48-72 h of delivery or abortion.

Antiendotoxin antibody is protective against tubal damage in an Escherichia coli rabbit salpingitis model.

OBJECTIVE: This study was designed to determine whether pretreatment with an endotoxin antibody reduces tubal damage and tumor necrosis factor-alpha production in an Escherichia coli rabbit salpingitis model. STUDY DESIGN: Twenty New Zealand White rabbits underwent laparotomy with direct inoculation of Escherichia coli into the fallopian tube. The animals were given either antibody and antibiotic, antibiotic alone, or no treatment. At 7 days the degree of tubal damage was measured by gross observation, light microscopy, and electron microscopy. Serum tumor necrosis factor-alpha levels were also assayed at 0, 2, 4, and 36 hours. RESULTS: Animals pretreated with antiendotoxin antibody demonstrated significantly less damage on the basis of gross observation and electron microscopy compared with both antibiotic alone and untreated animals. Tumor necrosis factor-alpha levels were also significantly reduced at 2 and 4 hours in the antibody-treated group. CONCLUSIONS: Endotoxin plays a direct role in tubal damage in this Escherichia coli salpingitis model, and damage can be blocked, in part, by pretreatment with antiendotoxin antibody. Tumor necrosis factor-alpha appears to play a significant role in mediating tubal damage resulting from endotoxin.

Pelvic inflammatory disease.

Pelvic inflammatory disease is a common serious complication of the sexually transmitted pathogens Neisseria gonorrhoeae and Chlamydia trachomatis. There are more than 800,000 cases of pelvic inflammatory disease annually accounting for approximately 200,000 hospital admissions for acute and chronic infections. Early accurate diagnosis and treatment are essential to prevent the serious sequelae including ectopic pregnancy, tubal disease infertility, chronic pain, and disability requiring multiple hospitalizations and surgery. Although clinical models to aid in the diagnosis and management of pelvic inflammatory disease have been developed by numerous investigators, all have lacked the sensitivity and specificity to be helpful to the clinician. Laparoscopy, considered by many to be the "gold standard" for diagnosis, is underutilized, and the definition of pelvic infection differs between investigators. Improved patient compliance and safety may be seen if single-agent therapy for acute pelvic inflammatory disease becomes a reality. In a small prospective randomized study, oral ofloxacin was as effective as cefoxitin plus doxycycline for outpatient treatment of chlamydial and gonococcal pelvic inflammatory disease. Treatment of tuboovarian abscess appears to be successful with single agent and combination therapy. Risk factors for developing postabortion endometritis continue to be identified, and the most efficacious prophylactic antibiotic regimen has not been determined to date.

Oxygen free radicals and pelvic adhesion formation: II. The interaction of oxygen free radicals and adhesion-preventing solutions.

A three-part animal and in vitro study gives evidence that oxygen free radicals are produced by intraperitoneal macrophages in response to pelvic surgery. These macrophages appear to ingest high-molecular-weight substances used to prevent adhesions (such as 32% dextran 70 and carboxymethylcellulose). However, the production of oxygen free radicals is not enhanced by the presence of 32% dextran 70 or carboxymethyl cellulose.

Outpatient sedation: an essential addition to gynecologic care for persons with mental retardation.

Routine gynecologic care for persons with mental retardation may be difficult to provide, especially to those women who do not allow a pelvic examination to be performed. Of 275 women referred to a multidisciplinary clinic addressing the reproductive health concerns of mentally retarded women, 61 patients (22%) did not allow a gynecologic examination to be performed. The administration of ketamine alone, midazolam alone, or a combination of midazolam and ketamine allowed for the successful performance of a gynecologic examination in 81% of previously uncooperative women. No adverse effects of the medications were noted. We conclude that sedation of difficult-to-examine, mentally handicapped women can be safely performed in the outpatient setting, thus avoiding the need for general anesthesia and its inherent risks.

Prevention of osteoporosis by medroxyprogesterone acetate in postmenopausal women.

The effect of medroxyprogesterone acetate 10 mg BID alone, conjugated estrogens alone or in a combination regimen for the prevention of osteoporosis was determined in 36 postmenopausal women using single photon densitometry. No significant differences in cortical or trabecular bone mass over time were detected in women between the three treatment groups, although a slight increase in bone mass was noted in women with the combined therapy. Medroxyprogesterone acetate appears efficacious in preventing postmenopausal osteoporosis, and may be especially useful in women with contraindications to estrogen replacement therapy.

Reproductive health concerns in Down syndrome. A report of eight cases.

People with Down syndrome represent a wide variety of mental and social ranges in functional capacity. Eight cases illustrate the range of reproductive health concerns seen in that group.