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Journal of Clinical Oncology | 2005

Retrospective Analysis of Selective Lymphadenectomy in Apparent Early-Stage Endometrial Cancer

Janiel M. Cragun; Laura J. Havrilesky; Brian Calingaert; Ingrid S. Synan; Angeles Alvarez Secord; John T. Soper; Daniel L. Clarke-Pearson; Andrew Berchuck

PURPOSE Selective lymphadenectomy is widely accepted in the management of endometrial cancer. Purported benefits are individualization of adjuvant therapy based on extent of disease and resection of occult metastases. Our goal was to assess effects of the extent of selective lymphadenectomy on outcomes in women with apparent stage I endometrial cancer at laparotomy. PATIENTS AND METHODS Patients with endometrial cancer who received primary surgical treatment between 1973 and 2002 were identified through an institutional tumor registry. Inclusion criteria were clinical stage I/IIA disease and procedure including hysterectomy and selective lymphadenectomy (pelvic or pelvic + aortic). Exclusion criteria included presurgical radiation, grossly positive lymph nodes, or extrauterine metastases at laparotomy. Recurrence and survival were analyzed using Kaplan-Meier analysis and Cox proportional hazards model. RESULTS Among 509 patients, the median number of lymph nodes removed was 15 (median pelvic, 11; median aortic, three). Pelvic and aortic node metastases were found in 24 (5%) of 509 patients and 11 (3%) of 373 patients, respectively. Patients with poorly differentiated cancers having more than 11 pelvic nodes removed had improved overall survival (hazard ratio [HR], 0.25; P < .0001) and progression-free survival (HR, 0.26; P < .0001) compared with patients having poorly differentiated cancers with 11 or fewer nodes removed. Number of nodes removed was not predictive of survival among patients with cancers of grade 1 to 2. Performance of aortic selective lymphadenectomy was not associated with survival. Three (27%) of 11 patients with microscopic aortic nodal metastasis are alive without recurrence. CONCLUSION These data add to the literature documenting the possible therapeutic benefit of selective lymphadenectomy in management of patients with apparent early-stage endometrial cancer.


American Journal of Obstetrics and Gynecology | 1983

Venous thromboembolism prophylaxis in gynecologic oncology: A prospective, controlled trial of low-dose heparin

Daniel L. Clarke-Pearson; R. Edward Coleman; Ingrid S. Synan; Wanda Hinshaw; William T. Creasman

One hundred eighty-five patients undergoing operation for gynecologic malignancy participated in a randomized controlled trial of low-dose heparin prophylaxis. Prospective surveillance for deep venous thrombosis was performed with daily fibrinogen 125I counting in the legs and impedance plethysmography. Twelve of 97 (12.4%) patients in the control group and 13 of 88 (14.8%) patients in the low-dose heparin group developed a venous thromboembolic complication. There was no statistical difference in the incidence of proximal deep vein thrombosis, calf vein thrombosis, or pulmonary emboli between the control and low-dose heparin groups. Low-dose heparin does not afford any prophylactic benefit to patients undergoing major pelvic operative procedures for gynecologic malignancy.


American Journal of Obstetrics and Gynecology | 1993

A randomized trial of low-dose heparin and intermittent pneumatic calf compression for the prevention of deep venous thrombosis after gynecologic oncology surgery.

Daniel L. Clarke-Pearson; Ingrid S. Synan; Richard K. Dodge; John T. Soper; Andrew Berchuck; R. Edward Coleman

OBJECTIVE Our aim was to determine the relative efficacy and complications of low-dose heparin and intermittent pneumatic calf compression for the prevention of postoperative venous thrombosis in patients undergoing surgery for gynecologic malignancy. STUDY DESIGN Randomized trial comparing 107 patients treated with low-dose heparin to 101 patients treated with intermittent pneumatic calf compression was performed. All patients were evaluated with iodine-125 fibrinogen scanning of the legs. Clinical and laboratory variables associated with bleeding complications were recorded prospectively. RESULTS Venous thrombosis was diagnosed in seven patients receiving low-dose heparin and in four receiving intermittent pneumatic calf compression (p = 0.54). Low-dose heparin patients received more blood transfusions postoperatively (p = 0.02), had increased volume of retroperitoneal drainage (p = 0.02), and the activated partial thromboplastin time was more frequently prolonged (p = 0.001). CONCLUSIONS Low-dose heparin and intermittent pneumatic calf compression provide similar reduction in reducing the incidence of postoperative venous thrombosis. However, low-dose heparin is more frequently associated with postoperative bleeding complications.


Obstetrics & Gynecology | 2003

venous Thromboembolism Prophylaxis: Patients at High Risk to Fail Intermittent Pneumatic Compression

Daniel L. Clarke-Pearson; Richard K. Dodge; Ingrid S. Synan; R. Craig McClelland; G. Larry Maxwell

Abstract Objective To identify patients who fail intermittent pneumatic compression and who might be considered for other more intense thromboembolic prophylaxis. Methods We conducted a retrospective review of consecutive gynecologic surgery patients treated with intermittent pneumatic compression. Risk factors associated with thromboemboli and demographic data were reviewed. Clinical suspicion of thromboemboli was confirmed by established diagnostic techniques such as duplex Doppler ultrasound and ventilation perfusion scanning. The association between individual risk factors and the incidence of thromboemboli was identified. To control for confounding of variables, multivariable stepwise logistic regression analysis was performed. Results A total of 1862 patients undergoing gynecologic surgery between 1996 and 1997 were treated perioperatively with intermittent pneumatic compression. The overall incidence of postoperative thromboemboli was 1.3% (15 cases of clinically significant postoperative pulmonary emboli and nine deep venous thrombosis). Risk factors associated with the occurrence of thromboemboli were: cancer (P = .001), history of deep venous thrombosis (P = .03), hypertension (P = .05), use of antihypertensives (P = .04), and age at least 60 years (P = .002). Intraoperative risk factors included duration of anesthesia more than 3 hours (P = .05). The multivariable regression analysis found that the diagnosis of cancer (P = .001), history of deep venous thrombosis (P = .006), and age greater than 60 years (P = .04) were independent prognostic factors. Patients with two or three of these variables had a 3.2% incidence of developing thromboemboli as compared with a 0.6% incidence of thromboemboli if the patient had none or one risk factor. Conclusion Patients most likely to fail intermittent pneumatic compression prophylaxis include those with cancer, a past history of deep venous thrombosis, or who are 60 years or older. This information identifies a “higher-risk” group of patients who should be considered for more intense prophylaxis programs.


American Journal of Obstetrics and Gynecology | 1984

The natural history of postoperative venous thromboemboli in gynecologic oncology: A prospective study of 382 patients

Daniel L. Clarke-Pearson; Ingrid S. Synan; R.Edward Colemen; Wanda Hinshaw; William T. Creasman

Three hundred eighty-two patients who underwent major operations for gynecologic malignancy were studied prospectively to determine the natural history of postoperative venous thromboemboli. Iodine 125-labeled fibrinogen leg counting, to diagnose deep venous thrombosis, was performed daily. Sixty-three patients (17%) developed postoperative venous thromboembolic complications. Deep venous thrombosis initially arose in the calf veins in 52 patients. Twenty-seven percent of these thrombi lysed spontaneously. Four percent of thrombi in the calf veins progressed to deep venous thrombosis in the femoral vein, and 4% resulted in pulmonary emboli. Nine other patients developed proximal deep venous thrombosis without prior thrombosis in the calf veins. One patient with proximal deep venous thrombosis also had a pulmonary embolus. Two patients with no evidence of deep venous thrombosis on prospective 125I-labeled fibrinogen leg counting developed pulmonary emboli, including one fatal pulmonary embolus that was found at autopsy to have arisen from the internal iliac veins. Fifty percent of all venous thromboemboli were detected within 48 hours of operation, although two patients developed significant deep venous thrombosis and pulmonary emboli after discharge from the hospital. These results add important information to our understanding of this disease process, and raise issues related to appropriate treatment and prophylaxis of venous thromboembolism in patients after gynecologic operations.


International Journal of Gynecology & Obstetrics | 1987

Variables associated with postoperative deep venous thrombosis: A prospective study of 411 gynecology patients and creation of a prognostic model

Daniel L. Clarke-Pearson; Elizabeth R. DeLong; Ingrid S. Synan

Deep venous thrombosis is a major complication following gynecologic surgery. Assessing a patients risk of developing deep venous thrombosis is important for patient selection and in choosing appropriate prophylactic methods. Four hundred eleven patients undergoing major gynecologic surgery were evaluated prospectively. All known variables associated with deep venous thrombosis were recorded. Deep venous thrombosis was diagnosed by 125I fibrinogen leg counting of all patients. Univariate analysis of all variables identified the following to be significantly related (P<.05) to postoperative deep venous thrombosis: a prior history of deep venous thrombosis, leg edema or venous stasis changes, venous varicosities, degree of preoperative ambulation, type of surgery, nonwhite race, recurrent malignancy, prior pelvic radiation therapy, age above 45 years, excessive body weight, intraoperative blood loss, and duration of anesthesia. A stepwise logistic regression analysis of these variables was performed. The following preoperative prognostic factors remained significant: type of surgery, age, leg edema, nonwhite patients, severity of venous varicosities, prior radiation therapy, and prior history of deep venous thrombosis. Duration of anesthesia was also important when intraoperative factors were considered in the analysis. Using these factors, a prognostic model was created and tested. The model resulted in a degree of concordance of 0.82 and allows one to evaluate the risks of postoperative deep venous thrombosis for an individual patient. (Obstet Gynecol 69:146, 1987)


Gynecologic Oncology | 1984

Perioperative external pneumatic calf compression as thromboembolism prophylaxis in gynecologic oncology: Report of a randomized controlled trial☆

Daniel L. Clarke-Pearson; William T. Creasman; R. Edward Coleman; Ingrid S. Synan; Wanda Hinshaw

Postoperative venous thromboembolic complications are a major problem for the gynecologic oncologist. External pneumatic calf compression (EPC), when applied intraoperatively and left on the patients legs for 5 days postoperatively, has been previously demonstrated to significantly reduce the incidence of venous thromboembolic complications in patients undergoing surgery for pelvic malignancies. The purpose of this study is to evaluate whether a short perioperative course of EPC is also effective in preventing venous thromboembolic complications. One hundred ninety-four patients participated in a randomized controlled trial of perioperative external pneumatic calf compression. 125I-labeled fibrinogen scanning and impedance plethysmography were used as prospective surveillance methods in both groups. Venous thromboembolic complications were diagnosed in 12.4% of control group patients and in 18.6% of EPC group patients. External pneumatic calf compression when used only in the perioperative period appears to be of no benefit in reducing the incidence of postoperative venous thromboembolic complications.


American Journal of Obstetrics and Gynecology | 1983

Anticoagulation therapy for venous thromboembolism in patients with gynecologic malignancy

Daniel L. Clarke-Pearson; Ingrid S. Synan; William T. Creasman

Anticoagulation therapy in 74 patients with gynecologic malignancy and venous thromboembolism was evaluated as to hemorrhagic complications, recurrent thrombosis, and completion of prescribed course. Clinically significant bleeding complications occurred in 25 patients and the course of anticoagulant therapy was not completed in 29 patients because of bleeding complications or death within 3 months. Venous thromboembolism recurred in 11% of patients. Risk factors associated with hemorrhagic complications and unsuccessful completion of anticoagulation therapy include advanced age, advanced stage of malignancy, incomplete surgical resection of tumor, and systemic chemotherapy. Complications of anticoagulant therapy were found to be excessive when compared to those in reports dealing with noncancer patients and may exceed the benefits of therapy in certain patients. Alternative methods of management for this group of high-risk patients are discussed.


Obstetrics & Gynecology | 2002

Preference and compliance in postoperative thromboembolism prophylaxis among gynecologic oncology patients

G. Larry Maxwell; Ingrid S. Synan; Risa P. Hayes; Daniel L. Clarke-Pearson

OBJECTIVE To compare low molecular weight heparin and external pneumatic compression in terms of patient preference and compliance to determine if either of these two methods is superior in postoperative thromboembolism prophylaxis of gynecologic oncology patients. METHODS A total of 211 patients undergoing major surgery for a suspected gynecologic malignancy were randomized to receive thromboembolism prophylaxis with either external pneumatic compression or low molecular weight heparin. Surveys regarding thromboembolism prophylaxis were completed by patients before surgery and approximately 7 days postoperatively. Patient preferences as well as reasons for patient dissatisfaction with prophylactic methods were elicited in the questionnaires. In addition, patient compliance with prophylaxis was recorded twice a day during hospitalization. Patients were not considered to be compliant with prophylaxis if the external pneumatic compression device was not functioning properly or if the administration of low molecular weight heparin was not given in a timely manner. RESULTS The majority of patients were satisfied with the prophylactic method that they received to the extent that they would prefer the treatment they received to one they had not necessarily experienced. The postoperative preferences of 78% of patients receiving low molecular weight heparin and 74% of those wearing external pneumatic compression corresponded to what the patients actually received as a method of thromboembolism prevention. Patient compliance with prophylaxis was noted to be inadequate in ten of 104 (9.6%) patients receiving external pneumatic compression and seven of 103 (6.8%) patients receiving low molecular weight heparin. CONCLUSION Pneumatic compression and low molecular weight heparin are similar both in terms of patient preference and compliance among gynecologic oncology patients receiving postoperative thromboembolism prophylaxis.


Gynecologic Oncology | 1982

Significant venous thromboembolism caused by pelvic lymphocysts: Diagnosis and management

Daniel L. Clarke-Pearson; Ingrid S. Synan; William T. Creasman

Abstract Lymphocysts are an infrequent complication of pelvic lymphadenectomy, but may lead to serious complications. Previous reviews have discussed the etiology, diagnosis, and management of lymphocysts. We present three cases of venous thromboembolic complications secondary to venous compression and stasis from a lymphocyst. Evaluation of venous dynamics by impedance plethysmography differentiates between venous obstruction and/or lymphedema. The subsequent management of extrinsic venous obstruction with and without thrombosis is discussed.

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Daniel L. Clarke-Pearson

University of North Carolina at Chapel Hill

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John T. Soper

University of North Carolina at Chapel Hill

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