An integrated strategy for improving contrast, durability, and portability of a Pocket Colposcope for cervical cancer screening and diagnosis.

INTRODUCTION: We have previously developed a portable Pocket Colposcope for cervical cancer screening in resource-limited settings. In this manuscript we report two different strategies (cross-polarization and an integrated reflector) to improve image contrast levels achieved with the Pocket Colposcope and evaluate the merits of each strategy compared to a standard-of-care digital colposcope. The desired outcomes included reduced specular reflection (glare), increased illumination beam pattern uniformity, and reduced electrical power budget. In addition, anti-fogging and waterproofing features were incorporated to prevent the Pocket Colposcope from fogging in the vaginal canal and to enable rapid disinfection by submersion in chemical agents. METHODS: Cross-polarization (Generation 3 Pocket Colposcope) and a new reflector design (Generation 4 Pocket Colposcope) were used to reduce glare and improve contrast. The reflector design (including the angle and height of the reflector sidewalls) was optimized through ray-tracing simulations. Both systems were characterized with a series of bench tests to assess specular reflection, beam pattern uniformity, and image contrast. A pilot clinical study was conducted to compare the Generation 3 and 4 Pocket Colposcopes to a standard-of-care colposcope (Leisegang Optik 2). Specifically, paired images of cervices were collected from the standard-of-care colposcope and either the Generation 3 (n = 24 patients) or the Generation 4 (n = 32 patients) Pocket Colposcopes. The paired images were blinded by device, randomized, and sent to an expert physician who provided a diagnosis for each image. Corresponding pathology was obtained for all image pairs. The primary outcome measures were the level of agreement (%) and κ (kappa) statistic between the standard-of-care colposcope and each Pocket Colposcope (Generation 3 and Generation 4). RESULTS: Both generations of Pocket Colposcope had significantly higher image contrast when compared to the standard-of-care colposcope. The addition of anti-fog and waterproofing features to the Generation 3 and 4 Pocket Colposcope did not impact image quality based on qualitative and quantitative metrics. The level of agreement between the Generation 3 Pocket Colposcope and the standard-of-care colposcope was 75.0% (kappa = 0.4000, p = 0.0028, n = 24). This closely matched the level of agreement between the Generation 4 Pocket Colposcope and the standard-of-care colposcope which was also 75.0% (kappa = 0.4941, p = 0.0024, n = 32). CONCLUSION: Our results indicate that the Generation 3 and 4 Pocket Colposcopes perform comparably to the standard-of-care colposcope, with the added benefit of being low-cost and waterproof, which is ideal for use in resource-limited settings. Additionally, the reflector significantly reduces the electrical requirements of the Generation 4 Pocket Colposcope enhancing portability without altering performance compared to the Generation 3 system.

International Image Concordance Study to Compare a Point-of-Care Tampon Colposcope With a Standard-of-Care Colposcope.

OBJECTIVE: Barriers to cervical cancer screening in low-resource settings include lack of accessible, high-quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low-cost, intravaginal, optical cervical imaging device, the point-of-care tampon (POCkeT) colposcope and evaluated whether its performance is comparable with a standard-of-care colposcope. MATERIALS AND METHODS: There were 2 protocols, which included 44 and 18 patients. For the first protocol, white-light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high-, middle-, and low-income countries. For the second protocol, green-light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high- and low-income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs. RESULTS: For the first protocol, average percent agreement between devices was 70% across all physicians. The POCkeT and standard-of-care colposcope images had 37% and 51% agreement with pathology for high-grade squamous intraepithelial lesions (HSILs), respectively. Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the 2 devices achieved similar agreement to pathology for HSIL lesions (55%). CONCLUSIONS: Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low-cost POCkeT colposcope was comparable to a standard-of-care colposcope.

An association between Trichomonas vaginalis and high-risk human papillomavirus in rural Tanzanian women undergoing cervical cancer screening.

OBJECTIVE: The goal of this study was to determine the prevalence of vaginitis and its association with high-risk human papillomavirus (HR HPV) in women undergoing cervical cancer screening in rural Tanzania. METHODS: For the purpose of cervical cancer screening, cytology and HR HPV polymerase chain reaction data were collected from 324 women aged between 30 and 60 years. Microscopy and gram stains were used to detect yeast and bacterial vaginosis. Cervical nucleic acid amplification test specimens were collected for the detection of Trichomonas vaginalis (TV), Chlamydia trachomatis, and Neisseria gonorrhoeae. RESULTS: The majority of women were married (320 of 324) and reported having a single sexual partner (270 of 324); the median age of participants was 41 years. HR HPV was detected in 42 participants. Forty-seven percent of women had vaginitis. Bacterial vaginosis was the most common infection (32.4%), followed by TV (10.4%), and yeast (6.8%). In multivariable logistic regression analysis, TV was associated with an increased risk of HR HPV (odds ratio, 4.2 [95% CI, 1.7-10.3]). Patients with TV were 6.5 times more likely to have HPV type 16 than patients negative for TV (50% vs 13.3%) (odds ratio, 6.5 [95% CI, 1.1-37]). CONCLUSIONS: Among rural Tanzanian women who presented for cervical cancer screening, Trichomonas vaginitis was significantly associated with HR HPV infection (specifically type 16).

Panniculectomy and abdominoplasty in patients undergoing gynecologic surgery: a single center case series of 15 combined procedures.

The current obesity epidemic poses significant challenges to surgical specialists striving to safely and effectively deliver medical care. In the United States, approximately 33.3% of men and 35.3% of women are classified as obese. Pelvic surgery, especially in patients with gynecological malignancies and those who require complex surgical procedures carries additional risk because of the increased technical difficulty posed by excess abdominal wall tissues and increased difficulty in providing and maintaining exposure of the appropriate pelvic anatomy. Simultaneous panniculectomy or abdominoplasty in selected patients may provide better access and visualization of the surgical field, reduce operative difficulty, and decrease perioperative morbidity. We retrospectively reviewed our experience in 15 patients undergoing panniculectomy or abdominoplasty in conjunction with gynecologic surgery. This review was conducted after approval by the local institutional review board. Complications were analyzed, and 2 (13%) of the 15 patients were found to have major complications. The only statistically significant finding for prediction of a negative outcome was an association of hypertension and advanced age with increased risk of postoperative transfusion (P < 0.02).

Does significant medical comorbidity negate the benefit of up-front cytoreduction in advanced ovarian cancer?

BACKGROUND: The objective of the study was to determine if initial surgery (IS) or initial chemotherapy (IC) affects rates of optimal surgery and survival in a population with significant medical comorbidities. METHODS: Data of all patients with stage III-IV ovarian, peritoneal, and fallopian tube cancers diagnosed from 1995 to 2008 were reviewed. Clinical and pathologic data were abstracted. RESULTS: There were 551 cases for review: 255 (46.3%) received IS, and 296 (53.7%) received IC. Patients who received IC had higher stage (P < 0.001), higher-grade cancers (P < 0.001), higher mean CA-125 (P = 0.015), higher rates of diabetes (P = 0.006), hypertension (P = 0.008), and presurgical embolism (P < 0.022) and were older (P = 0.043). There was no difference with respect to body mass index, albumin, extent of surgery, or intensive care use. Rates of optimal cytoreduction were higher with IC compared with IS (72.7% vs 56.1%, P < 0.001). IS was associated with more blood loss (P = 0.005) and higher rates of postsurgical venous thrombosis (P < 0.001). Optimal cytoreduction predicted survival in both groups. Among optimal patients, IS improved median survival: progression-free survival of 14 months (IS) versus 12 months (IC), P = 0.004; overall survival of 58 months (IS) versus 34 months (IC), P = 0.002. Factors influencing this difference were receipt of IC and history of diabetes; both predictors of mortality: hazard ratios, 1.9 (95% confidence interval, 1.3-2.8; P < 0.001) and 1.8 (95% confidence interval, 1.02-3.1; P = 0.042), respectively. CONCLUSIONS: The achievement of optimal cytoreduction continues to be a significant predictor of survival, regardless of treatment approach. Patients selected for IS and in whom optimal cytoreduction was achieved had improvements in both progression-free survival and overall survival. However, the differences could not be explained by surgical effort alone as diabetes was independently associated with mortality.

Oregovomab maintenance monoimmunotherapy does not improve outcomes in advanced ovarian cancer.

PURPOSE: This phase III study tested the hypothesis that the CA-125-specific murine monoclonal antibody, oregovomab, administered as a monoimmunotherapy after front-line therapy in a selected ovarian cancer population would prolong time to relapse (TTR) and, ultimately, survival. PATIENTS AND METHODS: Patients with stage III to IV ovarian cancer with preoperatively elevated CA-125 and objectively defined characteristics were randomly assigned 4 to 12 weeks after front-line carboplatin and paclitaxel chemotherapy to maintenance monoimmunotherapy in a fully blinded protocol. Two mg of oregovomab or placebo was infused over 20 minutes at weeks 0, 4, and 8 and then 12 weeks until recurrence or up to year 5. Patients were evaluated with serial imaging and clinical evaluation for evidence of recurrence at quarterly visits. TTR was the primary end point. RESULTS: Three hundred seventy-three patients were accrued at more than 60 centers; 251 patients were assigned to oregovomab and 120 patients were assigned to placebo. The treatment arms were well balanced. There were no differences in the clinical outcomes between treatment groups. Median TTR measured from randomization after completion of chemotherapy for the integrated study was 10.3 months (95% CI, 9.7 to 13.0 months) for oregovomab and 12.9 months (95% CI, 10.1 to 17.4 months) for placebo (P = .29, log-rank test). The treatment was well tolerated. Grade 3 to 4 toxicity was reported in 24.6% of patients in the placebo group and 20.1% of patients in the oregovomab group, respectively. CONCLUSION: Although oregovomab has demonstrated bioactivity, the strategy of monoimmunotherapy is not effective as maintenance therapy after front-line treatment of a favorable subset of patients with advanced ovarian cancer. Future studies of this or other tumor-antigen specific immunization strategies should seek ways to further augment induced immunity.

CA125 velocity at relapse is a highly significant predictor of survival post relapse: results of a 5-year follow-up survey to a randomized placebo-controlled study of maintenance oregovomab immunotherapy in advanced ovarian cancer.

This report presents final survival survey results from a previously reported study using oregovomab immunotherapy in patients with advanced ovarian epithelial cancer. Follow-up surveys to 5 years from randomization were collected for the cohort of stage III/IV ovarian cancer patients achieving initial remission who received subsequent maintenance immunotherapy with oregovomab or placebo. The relationship of time-to-relapse, survival postrelapse, and overall survival was analyzed. One hundred forty-five patients in the intent-to-treat population and the hypothesis generating subset of 67 patients (debulked to < or =2 cm, CA125 < or =65 U/mL before cycle 3, normal CA125 and no evidence of disease postchemotherapy) previously reported were evaluated for long-term outcomes. Patterns of relapse and survival were consistent in both groups for the intent-to-treat population. Median survival time was 57.5 months for oregovomab and 48.6 months for placebo with an adjusted hazard ratio of 0.72 (95% confidence interval, 0.41-1.25). Median survival has not been reached in the hypothesis generating subset of patients receiving oregovomab. Cox multivariate regression analysis identified velocity of CA125 rise at relapse to be a highly statistically significant predictor of postrelapse outcome (P = 0.006). Although time-to-relapse may be a useful surrogate of survival in ovarian cancer immunotherapy studies, 5 years of follow-up has proved insufficient to permit a definitive survival analysis and it has been extended in ongoing phase III studies of oregovomab. Velocity of CA125 rise at relapse is a highly significant predictor of survival after relapse.

Initial chemotherapy followed by surgical cytoreduction for the treatment of stage III/IV epithelial ovarian cancer.

OBJECTIVE: The purpose of this study was to evaluate differences in morbidity, progression-free interval, and survival in women with advanced epithelial ovarian cancer treated with initial chemotherapy versus initial surgery. STUDY DESIGN: All women with epithelial ovarian cancer who were treated surgically at our hospital between January 1, 1995, and January 1, 2003, were eligible; the cases of 200 patients met the criteria and underwent retrospective chart review. RESULTS: Ninety-eight patients (49%) had initial chemotherapy, and 102 patients (51%) had initial surgery. Patients who received initial chemotherapy were more likely to have stage IV disease (initial chemotherapy, 27%, vs initial surgery, 8%; P = .042) and grade 3 disease (initial chemotherapy, 73%, vs initial surgery, 61%; P = .025). Optimal cytoreduction was achieved more often in patients who received initial chemotherapy (initial chemotherapy, 86%, vs initial surgery, 54%; P < .001). Only optimal cytoreduction (P = .022), and not treatment choice (P = .089), had an impact on median survival. CONCLUSION: Initial chemotherapy is a reasonable alternative to initial surgery for the treatment of selected patients with advanced epithelial ovarian cancer.

The utility of HPV DNA triage in the management of cytological AGC.

OBJECTIVE: Given the demonstrated utility of human papilloma virus DNA triage in the management of atypical squamous cells of undetermined significance, this study sought to evaluate the potential role of human papilloma virus DNA testing in the evaluation and management of cytological atypical glandular cells. STUDY DESIGN: Following institutional review board approval, 28 women presenting with cytological atypical glandular cells underwent repeat thin-prep cytology, Hybrid Capture 2 human papilloma virus DNA testing, colposcopic evaluation, Fisher electrosurgical conization, and endometrial sampling. Human papilloma virus test results in each patient were then correlated with histologic lesions, if present. RESULTS: Sixteen of the 28 study patients had pathologic lesions (11/28 high-grade squamous intraepithelial lesion, 3/28 low-grade squamous intraepithelial lesion, 1/28 adenocarcinoma in situ, 1/28 simple endometrial hyperplasia). Human papilloma virus DNA testing was available in 24 of 28 subjects (86%). The sensitivity of human papilloma virus positivity to predict the presence of cervical intraepithelial neoplasia was 100% (confidence interval 77% to 100%), specificity 64% (confidence interval 35% to 85%), positive predictive value 76%, and negative predictive value 100%. Women who tested human papilloma virus positive were 12 times more likely to have cervical intraepithelial neoplasia than women who were human papilloma virus negative (Fisher P<.001). Human papilloma virus positivity was not predictive of endometrial pathology; women who were human papilloma virus positive were less likely to have endometrial pathology than were women who were human papilloma virus negative (risk ratio 1.6, 95% confidence interval 0.01-1.7). CONCLUSION: Atypical glandular cells can represent a variety of lesions. The majority of the lesions will be squamous intraepithelial lesions of the cervix (50%), with high-grade squamous intraepithelial lesion present in 40% of subjects. Human papilloma virus DNA testing is a sensitive test for the presence of squamous intraepithelial lesion, with excellent negative predictive value for the absence of squamous intraepithelial lesion. The results of this study suggest human papilloma virus DNA testing might be an effective screening test in the initial evaluation and management of cytological atypical glandular cells.

Predictors of suboptimal surgical cytoreduction in women treated with initial cytoreductive surgery for advanced stage epithelial ovarian cancer.

OBJECTIVE: The purpose of this study was to determine if a suboptimal cytoreduction can be predicted preoperatively in women with advanced ovarian cancer. STUDY DESIGN: All women with stage III/IV epithelial ovarian cancer treated with initial surgery at our hospital between January 1, 1995 and January 1, 2003 were eligible; 56 patients met inclusion criteria and underwent retrospective chart review. Statistical analysis was performed using SPSS. RESULTS: Twenty-nine women (52%) had optimal cytoreduction (OC), and 27 (48%) had suboptimal cytoreduction (SC). Women in the SC group had higher median CA-125 values at surgery (954 SC vs 597 OC, P = .07). Three sites of disease on preoperative CT were reported more frequently in the SC patients; omentum (P = .007), parietal peritoneum (P = .096), and ascites (P = .093). CONCLUSION: A suboptimal cytoreduction confers no survival advantage to women with advanced ovarian cancer. Thus, these patients may be the best candidates for initial chemotherapy, and identifying them preoperatively becomes important.

Stress response inhibits the nephrotoxicity of cisplatin.

Salt loading and saline hydration are used to protect patients from cisplatin-induced nephrotoxicity. The mechanism by which salt exerts its protective effect is unknown. As part of an ongoing study of cisplatin nephrotoxicity, an in vitro assay system was developed that models the in vivo exposure and response of proximal tubule cells to cisplatin. In this study, it was discovered that the toxicity of cisplatin toward LLC-PK(1) cells varied dramatically according to the tissue culture media used for 3-h cisplatin exposure. Further experiments revealed that minor variations in the sodium concentration among standard tissue culture media modulated cisplatin nephrotoxicity. NaCl has been shown to protect against cisplatin-induced nephrotoxicity in vivo but has never before been demonstrated in vitro. NaCl did not alter the cellular accumulation of cisplatin. NaCl altered the osmolarity of the external media, and its effect was replicated by substituting equiosmolar concentrations of impermeant anions or cations. The change in osmolarity triggered a stress response within the cell that modulated sensitivity to cisplatin. These data resolve several long-standing controversies regarding the mechanism by which salt loading protects the kidney from cisplatin-induced nephrotoxicity.

Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer.

PURPOSE: To assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunotherapeutic strategy for subsequent study. PATIENTS AND METHODS: Patients with stage III/IV ovarian cancer who had a complete clinical response to primary treatment were randomly assigned to oregovomab or placebo administered at weeks 0, 4, and 8, and every 12 weeks up to 2 years or until recurrence. The primary end-point was time to relapse (TTR). RESULTS: One hundred forty-five patients were treated with oregovomab (n = 73) or placebo (n = 72). For the population overall, median TTR was not different between treatments at 13.3 months for oregovomab and 10.3 months for placebo (P =.71). Immune responses were induced in most actively treated patients. This was associated with prolonged TTR. Quality of life was not adversely impacted by treatment. Adverse events were reported with similar frequency in oregovomab and placebo groups, indicating a benign safety profile. A long-term survival follow-up is ongoing. Cox analysis of relapse data identified significant factors: performance status, CA-125 before third cycle, and baseline CA-125. Further evaluation identified a subpopulation with favorable prognostic indicators designated as the successful front-line therapy (SFLT) population. For the SFLT population, TTR was 24.0 months in the oregovomab group compared with 10.8 months for placebo (unadjusted hazard ratio of 0.543 [95% CI, 0.287 to 1.025]), a hypothesis-generating observation. CONCLUSION: Consolidation therapy with oregovomab did not significantly improve TTR overall. A set of confirmatory phase III studies has been initiated to determine whether the SFLT population derives benefit from oregovomab treatment.

Biopsy of lesions of the female genital tract in the ambulatory setting.

The organs of the female genital tract (vulva, vagina, cervix, uterus, ovaries, and fallopian tubes) are capable of elaborating an immense array of pathologic conditions. These conditions can be primarily infectious in nature, or they can be neoplastic, precancerous, or frankly cancerous. In most instances the patient's history and physical examination alone are insufficient to establish a diagnosis, given the extreme similarity in clinical presentation of the various abnormalities of the female genital tract and the subtle differences that distinguish one from the other. In order to definitively establish the diagnosis, it is often necessary to obtain a tissue sample. Most clinicians are intimidated at the prospect of performing a biopsy of the lower female genital tract given concerns for patient discomfort and bleeding, in conjunction with a lack of familiarity with the specific techniques and instruments available to perform these biopsies. Conditions may go undiagnosed, or there may be a significant delay in diagnosis, as a result. In fact, failure to biopsy and obtain an accurate diagnosis in a timely fashion is a major concern from the medicolegal perspective. There is an increasing emphasis upon ambulatory care in our society. For this reason, it is essential that the clinician be familiar with the techniques that permit safe and reliable tissue diagnosis in the outpatient setting. This article is intended to describe the various techniques available to biopsy the organs of the female genital tract, as well as the instruments designed and uniquely suited for that purpose. An extensive Medline search was performed from the years 1965-2003, cross-referencing the terms "biopsy techniques" and "organs of the female genital tract." The results of this analysis detail both incisional and excisional biopsy techniques that can be safely employed by the clinician in the out-patient or ambulatory settings to obtain tissue samples to aid in initial diagnosis, or to accomplish therapeutic excision in order to definitively address a previously known condition. Being aware of the various biopsy techniques available for the outpatient evaluation of the female genital tract, and being comfortable with their use, increases the likelihood that abnormalities of the reproductive organs will be expeditiously evaluated, accurately diagnosed, and appropriately treated in a timely fashion.

Minimizing the risk of neurologic injury in gynecologic surgery.

OBJECTIVE: The association of intraoperative neurologic injuries with gynecologic surgical procedures is well established. The sequelae of such injuries are usually transient and resolve with minimal intervention, although long-term disability can and does occasionally occur. The purpose of this study was to examine the mechanisms by which these injuries occur in order to reduce the risk of their occurrence. DATA SOURCES: A MEDLINE search was performed cross-referencing the index terms "neurological injury" and "gynecological surgery," from January 1, 1960 to December 31, 2002. METHODS OF STUDY SELECTION: This article, based on the data and results (Level I-III) obtained from the MEDLINE search, examined the most common neurologic injuries that occur in association with abdominal and vaginal surgical procedures routinely performed by gynecologists. TABULATION, INTEGRATION, AND RESULTS: Neurologic injuries after pelvic surgery all generally share a common etiology, specifically injury to one or more components of the lumbosacral nerve plexus. Three major factors that predispose to neurologic injury at the time of gynecological surgery are 1) the improper placement or positioning of self-retaining or fixed retractors, particularly those with deep lateral retractor blades; 2) improper positioning of patients in lithotomy position preoperatively; and 3) radical surgical dissection resulting in autonomic nerve disruption. Level I data strongly implicate the improper placement of self-retaining or fixed retractors as the most common cause of femoral nerve injury arising in association with abdominal surgical procedures. CONCLUSION: A thorough understanding of the anatomy of the lumbosacral nerve plexus and the mechanisms by which operative injuries to this plexus occur will enable the gynecologic surgeon to reduce the subsequent risk of their occurrence in his or her own surgical practice.

Endocervical curettage. Does it contribute to the management of patients with abnormal cervical cytology?

OBJECTIVE: To conduct a prospective analysis of whether endocervical curettage contributes to the management of patients with abnormal cervical cytology. STUDY DESIGN: Three hundred four consecutive patients being evaluated for abnormal squamous cervical cytology at the University of Virginia underwent routine endocervical curettage at the time of diagnostic colposcopy. RESULTS: Among the 304 patients evaluated colposcopically, the information provided by endocervical curettage changed treatment planning in only 13, or 4.27%. In none of these 13 patients would the omission of endocervical curettage at the time of diagnostic colposcopy have resulted in overlooking an occult invasive or microinvasive carcinoma. CONCLUSION: This prospective analysis did not find the information provided by the routine application of endocervical curettage at the time of diagnostic colposcopy to be helpful in the subsequent treatment planning of patients undergoing evaluation for cervical intraepithelial disease.

Leiomyosarcoma of the cervix.

BACKGROUND: Epithelioid leiomyosarcoma arising from the uterine cervix is extremely rare, with only three cases reported in the world literature. We present the case report of a 14-cm epithelioid leiomyosarcoma arising from the uterine cervix. CASE: A 47-year-old female presented with a 1-year history of worsening menorrhagia and was found to have a large pelvic mass extending into and filling the upper vagina. She underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, revealing a 14 x 10 x 9 cm cervical epithelioid leiomyosarcoma. CONCLUSION: Although exceedingly rare, leiomyosarcoma is able to arise primarily from the uterine cervix. Given its extreme rarity, management of cervical LMS must be extrapolated from the currently accepted management for uterine LMS.

Uterine perforation at the time of brachytherapy for carcinoma of the cervix.

OBJECTIVE: The reported incidence of uterine perforation by tandems at the time of vaginal brachytherapy for management of cervical cancer ranges from 1.75% to 10% per application. The potential ramifications of afterloading a tandem that is outside the uterine cavity within the pelvis are sufficiently severe, in terms of bowel injury, that a reliable means of determining tandem positioning at the time of placement is essential. METHODS: We examined a representative patient that underwent tandem placement for Federation Internationale of Gynecologic Oncologist (FIGO) stage Ib1 cervical Squamous Cell Carcinoma (SCCA). The information provided by conventional radiographic assessment and clinical impression was not helpful in ultimately determining tandem placement. RESULTS: Direct endoscopic visualization provided accurate and irrefutable evidence of tandem location and positioning prior to leaving the operating room. CONCLUSION: A variety of techniques have been described to assist in accurate placement of the uterine tandem prior to afterloading, when utilizing definitive chemoradiation in the management of cervical carcinoma. These include postoperative plain films or computerized tomography, versus intraoperative transabdominal or transrectal ultrasound guidance at the time of placement. Postoperative techniques that confirm perforation necessitate a second visit to the operating room, a second general anesthetic, as well as a treatment delay that may impact negatively upon central control rates in the long term. Intraoperative techniques have their limitations as well, particularly in the obese patient. With difficult or questionable insertions, direct endoscopic evaluation at the time of tandem insertion is the only means of knowing definitively the location of the tandem prior to leaving the operating room.

Effects of adjunctive Swedish massage and vibration therapy on short-term postoperative outcomes: a randomized, controlled trial.

OBJECTIVE: To examine the effects of adjunctive postoperative massage and vibration therapy on short-term postsurgical pain, negative affect, and physiologic stress reactivity. DESIGN: Prospective, randomized controlled trial. The treatment groups were: (1) usual postoperative care (UC); (2) UC plus massage therapy; or (3) UC plus vibration therapy. SETTING: The University of Virginia Hospital Surgical Units, Gynecology-Oncology Clinic, and General Clinical Research Center. SUBJECTS: One hundred and five (N = 105) women who underwent an abdominal laparotomy for removal of suspected cancerous lesions. INTERVENTIONS: All patients received UC with analgesic medication. Additionally, the massage group received standardized 45-minute sessions of gentle Swedish massage on the 3 consecutive evenings after surgery and the vibration group received 20-minute sessions of inaudible vibration therapy (physiotones) on the 3 consecutive evenings after surgery, as well as additional sessions as desired. OUTCOME MEASURES: Sensory pain, affective pain, anxiety, distress, analgesic use, systolic blood pressure, 24-hour urine free cortisol, number of postoperative complications, and days of hospitalization. RESULTS: On the day of surgery, massage was more effective than UC for affective (p = 0.0244) and sensory pain (p = 0.0428), and better than vibration for affective pain (p = 0.0015). On postoperative day 2, massage was more effective than UC for distress (p = 0.0085), and better than vibration for sensory pain (p = 0.0085). Vibration was also more effective than UC for sensory pain (p = 0.0090) and distress (p = .0090). However, after controlling for multiple comparisons and multiple outcomes, no significant differences were found. CONCLUSIONS: Gentle Swedish massage applied postoperatively may have minor effects on short-term sensory pain, affective pain, and distress among women undergoing an abdominal laparotomy for removal of suspected malignant tissues.