Marcia M. Moore

Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway.

ObjectiveTo determine the success of a clinical pathway for outpatient laparoscopic cholecystectomy (LC) in an academic health center, and to assess the impact of pathway implementation on same-day discharge rates, safety, patient satisfaction, and resource utilization. Summary Background DataLaparoscopic cholecystectomy is reported to be safe for patients and acceptable as an outpatient procedure. Whether this experience can be translated to an academic health center or larger hospital is uncertain. Clinical pathways guide the care of specific patient populations with the goal of enhancing patient care while optimizing resource utilization. The effectiveness of these pathways in achieving their goals is not well studied. MethodsDuring a 12-month period beginning April 1, 1999, all patients eligible for an elective LC (n = 177) participated in a clinical pathway developed to transition LC to an outpatient procedure. These were compared with all patients undergoing elective LC (n = 208) in the 15 months immediately before pathway implementation. Successful same-day discharges, reasons for postoperative admission, readmission rates, complications, deaths, and patient satisfaction were compared. Average length of stay and total hospital costs were calculated and compared. ResultsAfter pathway implementation, the proportion of same-day discharges increased significantly, from 21% to 72%. Unplanned postoperative admissions decreased as experience with the pathway increased. Patient characteristics, need for readmission, complications, and deaths were not different between the groups. Patients surveyed were highly satisfied with their care. Resource utilization declined, resulting in more available inpatient beds and substantial cost savings. ConclusionsImplementation of a clinical pathway for outpatient LC was successful, safe, and satisfying for patients. Converting LC to an outpatient procedure resulted in a significant reduction in medical resource use, including a decreased length of stay and total cost of care.

Intraoperative Ultrasound Is Associated With Clear Lumpectomy Margins for Palpable Infiltrating Ductal Breast Cancer

ObjectiveTo evaluate the efficacy of intraoperative ultrasound in obtaining adequate surgical margins in women undergoing lumpectomy for palpable breast cancer. Summary Background DataAdequacy of surgical margins is a subject of debate in the literature for women undergoing breast-conserving therapy. The emerging technology of intraoperative ultrasound-guided surgery lends itself well to a prospective study evaluating surgical accuracy and margin status after lumpectomy. MethodsTwo groups of women undergoing lumpectomy for palpable breast cancer were studied, one group using intraoperative ultrasound (n = 27) and the other without (n = 24). Pathologic specimens were evaluated for size, margins, and accuracy, and patients were questioned about satisfaction with cosmetic results. ResultsSurgical accuracy was improved with intraoperative ultrasound-guided surgery. Margin status was improved, patient satisfaction was equivalent, and cost was not affected using ultrasound technology. Intraoperative ultrasound appears especially efficacious for women whose preoperative mammogram shows dense parenchyma surrounding the lesion. ConclusionsThe use of ultrasound-guided surgery optimizes the surgeon’s ability to obtain satisfactory margins for breast-conserving techniques in patients with breast cancer. Patient satisfaction is excellent and a cost savings is most likely realized.

Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial.

BACKGROUND Patients who have axillary dissections during lumpectomy or modified radical mastectomy for breast carcinoma accumulate serosanguinous fluid, potentially resulting in a seroma. Currently accepted practice includes insertion of one or more drains for fluid evacuation. This multicenter, randomized, controlled, phase II study was undertaken to evaluate whether a virally inactivated, investigational fibrin sealant is safe and effective when used as a sealing agent to reduce the duration and volume of serosanguinous fluid drainage and to determine the dose response of this effect. STUDY DESIGN Patients undergoing lumpectomy or modified radical mastectomy were randomized to treatment with 4, 8, or 16 mL of fibrin sealant or control (no agent) at the axillary dissections site. Patients undergoing modified radical mastectomy also received an additional 4 or 8 mL of fibrin sealant at the skin flap site. Efficacy was evaluated by the number of days required for wound drainage and the volume of fluid drainage compared with control. Safety was confirmed by clinical course, the absence of viral seroconversion, and no major complications attributable to the sealant. RESULTS The 4-mL axillary dissection dose of fibrin sealant significantly reduced the duration and quantity of fluid drainage from the axilla following lumpectomy (p < or = 0.05). In the modified radical mastectomy patients, a 16-mL axillary dissection dose combined with an 8-mL skin flap dose was significantly effective in reducing the number of days to drain removal (p < or = 0.05) and fluid drainage (p < or = 0.01). There were no fibrin sealant patient viral seroconversions and no major complications attributable to the sealant. A number of wound infections were noted, although this may represent a center-specific effect. CONCLUSIONS Application of fibrin sealant following axillary dissection at the time of lumpectomy or modified radical mastectomy can significantly decrease the duration and quantity of serosanguinous drainage. The viral safety of the product was also supported.

An Outcome Study of Breast Reconstruction: Presurgical Identification of Risk Factors for Complications

Background: Breast reconstruction following mastectomy has been shown to have a salutary effect on the overall psychological well-being of women being treated for breast cancer. Unfortunately, however, not every patient is an ideal candidate for reconstruction. Complications stemming from reconstructive surgery can cause significant morbidity, the most important of which may be the delay of subsequent adjuvant antineoplastic therapies, and therefore may not be in the best interests of the patient.Methods: A retrospective study was performed on a consecutive series of 123 breast reconstructions in 98 patients, performed by one of two plastic surgeons, in a university setting over a 5-year period, for all surgical outcomes. Specifically, wound-healing complications, infections, and reoperations leading to the potential delay of subsequent chemotherapy or radiotherapy were recorded, and possible risk factors leading to these were sought.Results: Three presurgical risk factors were found to have a statistically significant influence on the development of complications following breast reconstruction. These were: (1) increasing obesity, defined by the body mass index, (2) an active or recent (<5 year) history of cigarette smoking, and (3) a history of previous radiation exposure. Odds ratios were used to describe the magnitude of the effect of each factor for the development of complications. An ordinal regression analysis was used to create a nomogram based on this information that can be used to calculate any individual patient’s presurgical risk for developing major complications following breast reconstruction, based on the presence of these factors.Conclusions: It is possible, based on the presence of specific presurgical risk factors, to predict the probability of developing major complications following breast reconstruction. This information can be useful to the referring physician and plastic surgeon alike in determining which patients are the best candidates for breast reconstruction and which type of reconstruction would be best suited for each individual patient.

Association of infiltrating lobular carcinoma with positive surgical margins after breast-conservation therapy.

OBJECTIVE To determine whether infiltrating lobular carcinoma (ILC) is associated with high positive-margin rates for single-stage lumpectomy procedures, and to define clinical, mammographic, or histologic characteristics of ILC that might influence the positive-margin rate, thereby affecting treatment decisions. SUMMARY BACKGROUND DATA Infiltrating lobular cancer represents approximately 10% of all invasive breast carcinomas and is often poorly defined on gross examination. METHODS A group of 47 patients with biopsy-proven ILC undergoing breast-conservation therapy (BCT) at the University of Virginia Health Sciences Center between 1975 and 1999 was compared with a group of 150 patients with infiltrating ductal cancer undergoing BCT during the same time period. The pathology of the lumpectomy specimen was reviewed for each patient to confirm surgical margin status. Office and surgical notes as well as mammography reports were examined to determine whether the lesions were deemed palpable before and during surgery. Patients were stratified according to age, family history, tumor size, tumor location, and histologic features of the tumor. RESULTS The incidence of positive margins was greater in the ILC group compared with the infiltrating ductal cancer group. Patient age, family history, and preoperative palpability of the tumor did not correlate with surgical margin status. Of the mammographic features identified, including spiculated mass, calcifications, architectural distortion, and other densities, only architectural distortion predicted positive surgical margin status. Tumor grade, tumor size, lymph node status, and receptor status were not predictive of surgical margin status. CONCLUSIONS For patients with ILC, BCT is feasible, but these patients are at high risk of tumor-positive resection margins (51% incidence) after the initial resection. Only the mammographic finding of architectural distortion was identified as a preoperative marker reliably identifying a subgroup of ILC patients at especially high risk for a positive surgical margin. For all patients with ILC considering BCT, careful counseling about the potential need for a second procedure to treat the positive margin should be included in the treatment discussion.

Seroma prevention in a rat mastectomy model: use of a light-activated fibrin sealant.

Seroma formation following mastectomy and axillary dissection remains a common and significant problem contributing to patient morbidity and health-care costs. Previous data have suggested that fibrin sealant (FS), a biological adhesive, is capable of controlling lymphatic leakage and assisting with skin graft adhesion. In this study, the use of an experimental, light-activated FS under development by CryoLife (CFS) was evaluated in a rat mastectomy model in order to reduce seroma formation. CFS is a premixed form of FS, containing an inactivator that is reversed in the presence of light, causing sealant to form. In this model, rats underwent mastectomy and extensive dissection of the axillary lymphovasculature. Next, 1 ml of saline or FS was applied to the operative site and the wound was closed. Three groups of animals were evaluated 5 days postoperatively by measuring the volume (in milliliters) of seroma able to be aspirated from the surgical site. The saline control group (N = 20) had a seroma volume (mean ± standard deviation [SD]) of 4.2 ± 2.9 ml, while a form of CFS containing human fibrinogen (80 to 100 mg per milliliter) and human thrombin (20 U per milliliter) (N = 20) had a significantly smaller seroma volume of 1.1 ± 1.6 ml (p < 0.001 analysis of variance). University of Virginia (UVA) FS, containing human fibrinogen (20 mg per milliliter) and bovine thrombin (500 U per milliliter) (N = 20), had a serorna volume of 2.0 ± 1.6 ml (p < 0.01, compared to control; p > 0.2, compared to CFS). Thus, this form of CFS significantly reduced seroma formation compared to saline control and also appeared to result in a smaller fluid accumulation than with UVA FS, although this trend was not statistically significant. These data suggest that the use of CFS may help to reduce seroma formation in humans.

Use of fibrin sealant to reduce bleeding after needle liver biopsy in an anticoagulated canine model: work in progress.

PURPOSE Needle biopsy of the liver is a common diagnostic procedure. Although relatively safe, bleeding remains a potential complication and may occur more frequently in patients with coagulopathy. The purpose of this study was to evaluate the utility of a fibrin sealant in preventing bleeding after a 15-gauge needle biopsy of the liver in a canine model heparinized to simulate coagulopathy. MATERIALS AND METHODS Fibrin sealant was delivered to biopsy tract sites in eight dogs anticoagulated with heparin (activated clotting time 387 seconds +/- 94) using the same sheath system that was employed to obtain the biopsy specimen. RESULTS The results demonstrated complete hemostasis in the sealant-plugged tracts as compared to controls. Continuous bleeding was observed in none of the fibrin sealant-treated sites, compared with all of the control biopsy sites (P = .0078). CONCLUSION These results demonstrate the high degree of efficacy of fibrin sealant delivered through a sheath system in plugging liver biopsy tracts and eliminating bleeding in a severely coagulopathic animal model. This indicates that fibrin sealant use in cutting needle biopsies can reduce major and minor complications associated with the procedure.