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Biomedical subjects

J M Wheeler

Publications and source records attributed to J M Wheeler.

At least 37 records · Page 2Linked to original sources
PubMed1996

The degree of fluid absorption during hysteroscopic surgery in patients pretreated with goserelin.

STUDY OBJECTIVE: To assess the effects of pretreatment with the gonadotropin-releasing hormone analog goserelin on fluid absorption in patients undergoing hysteroscopic endometrial ablation. DESIGN: Prospective, randomized, placebo-controlled study. SETTING: A university-based clinic. PATIENTS: Thirteen women with dysfunctional uterine bleeding who were scheduled for electrosurgical hysteroscopic ablation. INTERVENTIONS: Seven women were randomized to receive luteal phase goserelin 3.75 mg and six saline in the menstrual cycle approximately 10 weeks before surgery. Operative hysteroscopy was carried out with glycine 1.5% mixed with 2% alcohol medium under constant pressure as an irrigant. The amount of irrigant used, irrigant deficit, blood levels of albumin and ethanol, hematocrit, hemoglobin, changes in sodium levels, and central venous pressure were compared between the groups. MEASUREMENTS AND MAIN RESULTS: All of the patients had an unsuccessful course of medical therapy for at least 3 months and a normal endometrial biopsy. The age, weight, and uterine size were similar between the groups. The mean volume of irrigant used and operating time were similar in both groups (4.18 +/- 0.2 vs 4.5 +/- 0.5 L, and 33.7 +/- 1.5 vs 37 +/- 2.1 min). Although operating time, volume deficit, decrease in protein level, and hematocrit were less in the goserelin than in the saline group, the differences were not statistically significant (p >0.05). The ethanol levels in blood, decrease in Na+, and irrigant deficit were significantly lower in the goserelin than in the saline group (17.4 +/- 3.8 vs 25.3 +/- 4.2 mg/ml, 6.7 +/- 1.2 vs 9.1 +/- 0.9 mEq/L, and 0.49 +/- 0.08 vs 0.66 +/- 0.05 L, respectively; p <0.05). CONCLUSION: Based on these results we conclude that in women undergoing hysteroscopic endometrial ablation, pretreatment with goserelin may decrease the absorption of hysteroscopic medium, prevent fluid overload, and improve the outcome possibly by causing hypovascularity and decreased endometrial growth.

Absorption↗
PubMed1995

Laparoscopic repair of bladder injury and laceration.

The management of bladder injuries at laparoscopy is controversial. Some endoscopists believe in mandatory open repair, whereas others recommend laparoscopic cystotomy repair. We performed laparoscopy to treat two women with bladder injury, one with excision of a transmural nodule of bladder endometriosis, and the other with incidental cystotomy during adenexectomy in the presence of obliterative adhesions. After localizing the injury to the dome of the bladder remote from ureters, the edges of the injury were cleaned of damaged tissue and apposed in two layers using interrupted 4-0 polydioxanone endocorporeal sutures. The patients had an uneventful postoperative course, and neither experienced bladder function problems. We conclude that applying the already established tenets of bladder injury repair by laparotomy to laparoscopic procedures is acceptable in most endoscopic settings.

Adnexal Diseases↗
PubMed1993

Depot leuprolide acetate versus danazol in the treatment of women with symptomatic endometriosis: a multicenter, double-blind randomized clinical trial. II. Assessment of safety. The Lupron Endometriosis Study Group.

OBJECTIVES: This is the first multicenter, double-blind randomized clinical trial that compares a depot gonadotropin-releasing hormone agonist with danazol in the treatment of endometriosis. Efficacy results have been previously reported; this report focuses on safety data. STUDY DESIGN: A total of 270 patients from 22 centers were randomly selected to receive either leuprolide acetate depot (3.75 mg injected monthly) or danazol (800 mg administered orally daily). Safety outcomes included adverse effects, clinical laboratory changes, and bone mineral density changes. RESULTS: Most patients receiving either drug reported side effects, most of which were related to the hypoestrogenism of leuprolide (e.g., vasodilatation) and relative hyperandrogenism of danazol (e.g., weight gain). Similarly small numbers of patients dropped out of the two treatment groups because of the side effects encountered. Leuprolide depot caused a greater decrease in bone density; preliminary data suggest a return to baseline on cessation of the drug. Danazol was associated with alteration of serum lipids, specifically a significant decrease in high-density lipoprotein. CONCLUSIONS: Although side effects were commonly reported in both groups, the drugs were similarly safe in terms of the absence of serious complications and the results of cessation of therapy. Side effects were largely reversible on discontinuation of medication. More longitudinal data are necessary before the possibility of long-term risks can be excluded, especially as they pertain to bone mineral density and lipids.

Adolescent↗
PubMed1992

Postoperative hyponatremic encephalopathy in menstruant women.

OBJECTIVES: To determine factors associated with the development of encephalopathy and with its clinical course in patients with postoperative hyponatremia. SETTING: Consultation and referral services of two university medical centers and community hospitals. DESIGN: Case-control study (risk factors for encephalopathy) and cohort study (clinical course among patients with encephalopathy). PATIENTS: Case patients included 65 adults with postoperative hyponatremic encephalopathy; controls included 674 adult patients who had postoperative hyponatremia without encephalopathy and who were selected from 76,678 consecutive adult surgical inpatients. MEASUREMENTS: Age, gender, menstrual status, neurologic symptoms, time to development and degree of hyponatremia, arterial blood gas determinations, serum chemistries, morbidity and mortality. RESULTS: Case patients included 40 women (62%) and 25 men (38%) (P > 0.05); controls included 367 women (54%) and 307 men (46%) (P > 0.1). Of the 34 case patients who developed permanent brain damage or died, 33 (97%) were women (P < 0.001). Among the women with brain damage, 25 (76%) were menstruant (P < 0.001). The relative risk for death or permanent brain damage from hyponatremic encephalopathy in women compared with men was 28 (95% Cl, 5 to 141) and in menstruant women compared with postmenopausal women, 26 (Cl, 11 to 62). Arterial PO2 at diagnosis was significantly lower in female than in male case patients (34 +/- 5 compared with 91 +/- 3 mm Hg; P < 0.001). Further, of the 38 case patients who had respiratory arrest before the diagnosis of hyponatremic encephalopathy, 36 (95%) were women. Extent of or time to development of hyponatremia did not correlate with subsequent brain damage (P > 0.1). CONCLUSIONS: Women and men are equally likely to develop hyponatremia and hyponatremic encephalopathy after surgery. However, when hyponatremic encephalopathy develops, menstruant women are about 25 times more likely to die or have permanent brain damage compared with either men or postmenopausal women.

Adult↗
PubMed1992

Depot leuprolide versus danazol in treatment of women with symptomatic endometriosis. I. Efficacy results.

OBJECTIVE: We aimed to assess the efficacy of depot leuprolide versus danazol in the treatment of endometriosis. STUDY DESIGN: A double-blind randomized trial of 270 patients from 22 centers compared the pretreatment and posttreatment laparoscopic extent of endometriosis. Pretreatment and posttreatment endometriosis symptoms and signs were assessed with standardized methods. RESULTS: When compared with danazol, leuprolide depot caused a more rapid and profound suppression of estradiol. Leuprolide depot and danazol were similarly efficacious in decreasing the extent of endometriosis, as well as the pain and tenderness associated with endometriosis. CONCLUSION: Depot leuprolide is an effective alternative to danazol in decreasing the extent of endometriosis and endometriosis-related pain.

Adolescent↗
PubMed1992

Coagulation profile in severe preeclampsia.

One hundred women with severe preeclampsia or chronic hypertension with superimposed preeclampsia were seen during a 2-year period. We sought to determine whether a normal platelet count assures that no other clinically significant clotting abnormalities are present, and what level of thrombocytopenia predicts a risk of abnormalities in other coagulation indices. Fifty women had platelet counts below 150,000/microL, of whom 13 had a fibrinogen level below 300 mg/dL and two had a prolonged prothrombin time (PT) or partial thromboplastin time (PTT). The admission platelet count was an excellent predictor of subsequent thrombocytopenia (r = 0.829, P less than .001). No subject had an abnormal fibrinogen level or prolonged PT or PTT in the absence of thrombocytopenia. When monitoring intrapartum coagulation indices in preeclampsia, one can safely follow only the platelet count at admission and subsequently, reserving PT and PTT and fibrinogen levels for those cases complicated by counts less than 100,000/microL.

Adult↗
PubMed1991

The use of an amniotic membrane graft to prevent postoperative adhesions.

Grafts of trypsin-treated, gamma-irradiated human amniotic membranes were used to cover injured uterine horns of nulliparous female rabbits to prevent adhesions. In this study, the gradual integration of the membranes into the serosal layer of the uterus, together with marked neovascularization, was observed. By the 30th postoperative day, the grafts had been completely integrated, with little evidence of rejection and no evidence of infection at the graft sites. Of 30 uterine horns treated with membrane grafts, only 4 (13.4%) showed any adhesion formation at or among the graft sites. All of the 24 untreated controls showed adhesion formation at the site of injury. Furthermore, whatever adhesions were found in membrane-treated horns could be graded as thin and filmy, accounting for less than 10% of the surface area of the graft, whereas the controls showed dense, thick adhesions covering 50% to 100% of the injured areas. We conclude that these specially prepared amniotic membranes are safe and effective in dramatically reducing postoperative adhesion formation in this animal model.

Animals↗
PubMed1991

Role of phase IV trials in determining the safety and efficacy of oral contraceptives. Guidelines for evaluation.

The continued evaluation of a new drug after it reaches the general marketplace is of ever-increasing concern for pharmaceutical manufacturers and regulatory agencies. This interest in performance after the drug has come to market has spawned a new type of research, "postmarketing surveillance," or phase IV research. Often when a new drug comes to market, a phase IV trial is implemented to reevaluate the results of previously performed controlled clinical trials. While the primary strength of a phase IV trial is that it gathers a large amount of prospective data on many patients in a short time, this type of study is limited in design as compared to the rigorous, randomized clinical trial required to "prove" efficacy. This paper offers the obstetrician-gynecologist and clinical epidemiologist a 10-point checklist to employ when evaluating phase IV trials involving an oral contraceptive.

Clinical Trials as Topic↗
PubMed1991

Incidence of breakthrough bleeding during oral contraceptive therapy.

A phase IV, open-label, multicenter survey of 983 obstetrician-gynecologists was conducted to evaluate the incidence of intermenstrual bleeding in 6,382 women receiving a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) over a six-month period. Most patients (75%) did not experience intermenstrual bleeding during therapy. Follow-up questionnaires were sent to the physicians of the 1,526 women reporting breakthrough bleeding or spotting; 1,027 follow-up questionnaires (67%) were returned. The questionnaires revealed that approximately one-fifth of the patients were placed on EDA 1 mg with EE 35 micrograms to regulate preexisting bleeding; of them, 71% reported an improvement, 13% reported worsening, and 16% reported no change in their cycle regularity. Most breakthrough bleeding or spotting (91%) occurred in the first three months of therapy in women with preexisting irregular bleeding as well as in those using the oral contraceptive solely for birth control. Although a fair proportion of women experienced intermenstrual bleeding, very few (5.1%) discontinued therapy because of it. Thus, the study demonstrated that the incidence of breakthrough bleeding and spotting appears to be within or below the range reported for other monophasic and multiphasic oral contraceptives. Further, in agreement with previously published reports, the data suggest that cycle control will improve after three months of oral contraceptive use.

Contraceptives, Oral, Hormonal↗
PubMed1991

Complexion changes in oral contraceptive users. Results from a phase IV multicenter trial evaluating the safety and efficacy of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms.

An open-label, phase IV, multicenter survey of obstetrician-gynecologists was conducted to evaluate the efficacy and safety of a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. Surveys from 983 community-based physicians reported on 6,382 women. Most patients did not experience "clinically noticeable complexion changes" (5,695/6,382, or 89.2%). Of the 687 patients with complexion changes, nearly three-fourths reported an improvement (501/687, or 72.9%). A follow-up questionnaire was sent to 127 respondents (18.6%) who reported worsening of the complexion; 70% of the questionnaires were returned. Most complexion worsening was of slight degree (63%), reported by the patient and not the physician (84% vs. 16%), and experienced during the first two to three months (84%). Although the literature includes many references to skin condition "improvement" on oral contraceptives, this report of a descriptive study gives clinicians as estimate of the incidence and severity of complexion changes in actual use.

Contraceptives, Oral, Hormonal↗
PubMed1991

Incidence of ovarian cyst formation in women taking ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms.

A total of 7,759 women were treated with ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) in a field study involving 983 obstetrician-gynecologists evaluating the incidence of ovarian cyst formation. Six thousand three hundred eighty-two patients were evaluable; 1,377 could not be evaluated because of failure to meet inclusion criteria or inconsistent or incomplete data collection. Cysts were detected in 80 patients at the time of the final visit. Follow-up questionnaires were received on 61% of patients and confirmed the presence of 12 newly formed ovarian cysts in patients taking EDA 1 mg with EE 35 micrograms. Only three women required an operation for ovarian cysts; two women had functional ovarian cysts (one follicular and one luteal), and one had a neoplastic cyst (cystadenoma). Thus, the incidence of ovarian cyst formation requiring surgical intervention was 0.05% in women taking EDA 1 mg with EE 35 micrograms.

Adult↗
PubMed1990

Outcome of twin-twin transfusion diagnosed before 28 weeks of gestation.

To develop prognostic indicators for those patients diagnosed with twin-twin transfusion before 28 weeks' gestation, we conducted a retrospective analysis of all cases diagnosed at Baylor College of Medicine from January 1985 through April 1989. Twenty-seven cases of twin-twin transfusion were diagnosed by ultrasound; the criteria for diagnosis were polyhydramnios in one amniotic cavity and oligohydramnios in the other cavity. The mean (+/- SD) age at diagnosis was 21.9 +/- 2.9 weeks and the mean age at delivery was 26.8 +/- 4.9 weeks. Gestational age at diagnosis was similar in survivors and non-survivors (21.7 +/- 3.7 versus 22.2 +/- 2.8 weeks; P = .35); however, surviving infants were delivered later in gestation (31.9 +/- 3.5 versus 25.9 +/- 3.4 weeks; P = .000008). The overall survival rate was 21%. Fetal hydrops correlated with poor survival. Amniocentesis for decompression and tocolysis failed to decrease perinatal mortality.

Adult↗
PubMed1990

Statistical methods in evaluating endometriosis studies.

There is no shortage of statistical methods available for use in presenting the results of endometriosis research. Those that are currently in widest use have underlying statistical assumptions that may not be met by our study populations. Those methods that are more robust and compensate more for defects in satisfying these underlying assumptions are computer-based and much less "friendly" to physician and patient alike in terms of comprehensibility. Statisticians, with little appreciation for clinical practice, cannot answer these questions alone. Research is needed by clinician scientists comparing the validity of these methods of analysis.

Biometry↗